PsA. SIMPONI (golimumab) Rheumatoid arthritis. Psoriatic arthritis. Ankylosing spondylitis EFFICACY EFFICACY EFFICACY. QoL. QoL.

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1 RA Rheumatoid arthritis PsA Psoriatic arthritis AS Ankylosing spondylitis EFFICACY EFFICACY EFFICACY QoL QoL QoL SAFETY SAFETY SAFETY EXPERIENCE EXPERIENCE EXPERIENCE SUMMARY SUMMARY SUMMARY Copyright 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved. RHEU /13

2 EFFICACY Signs and xxxxxxx symptoms of RA Clinical xxxxxxx remission Pre-erosive xxxxxxxx lesions Structural damage SIMPONI helps deliver a sustained reduction in the signs and symptoms of RA 1 RA ACR response at Week Patients, % ACR20 ACR50 ACR70 Placebo + MTX (n=39; switched to SIMPONI 50 mg monthly + MTX at Week 16) SIMPONI 50 mg monthly + MTX (n=70) ACR improvements were sustained over 2 years. 3 Week 14 HAQ-DI score

3 EFFICACY Signs and xxxxxxx symptoms of RA Clinical xxxxxxx remission Pre-erosive xxxxxxxx lesions Structural damage SIMPONI helps deliver a sustained reduction in the signs and symptoms of RA 1 RA ACR response at Week Patients, % P= P= ACR20 (PE) ACR50 ACR70 Placebo (n=133) SIMPONI 50 mg (n=89) P= ACR improvements were sustained over 2 years. 3 Week 14 Week 52 HAQ-DI score

4 EFFICACY Signs and xxxxxxx symptoms of RA Clinical xxxxxxx remission Pre-erosive xxxxxxxx lesions Structural damage SIMPONI helps deliver a sustained reduction in the signs and symptoms of RA 1 RA Almost 3 times more improvement in HAQ-DI scores vs placebo + MTX alone at Week 24 (0.38 vs 0.13, P<0.001) ACR improvements were sustained over 2 years. 3 Week 14 Week 52 HAQ-DI score

5 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage RA = rheumatoid arthritis; ACR = American College of Rheumatology; MTX = methotrexate; PE = primary end point; HAQ-DI = Health Assessment Questionnaire Disability Index. References 1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6): Erratum in: Ann Rheum Dis. 2011;70(1): Keystone EC, et al. Ann Rheum Dis. 2010;69(6): SIMPONI.. March 2012.

6 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered subcutaneously every 4 weeks. Primary end points were the proportion of patients with 20% improvement in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.

7 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage SIMPONI helps achieve and maintain clinical remission 1 RA DAS28 (CRP) remission at Week Patients, % P< Placebo + MTX (n=133) SIMPONI 50 mg + MTX monthly (n=89) Week 24 Week 52 DAS28 remission rates were maintained through Week

8 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage SIMPONI helps achieve and maintain clinical remission 1 RA DAS28 (CRP) remission at Week times as many patients achieved DAS28 remission vs MTX alone (27.0% vs 6.8%; P<0.001) at Week Patients, % P< Placebo + MTX (n=133) SIMPONI 50 mg + MTX monthly (n=89) Week 24 Week 52 DAS28 remission rates were maintained through Week

9 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage SIMPONI helps achieve and maintain clinical remission 1 RA Remission was sustained through Week 52 61% of patients initially receiving SIMPONI 50 mg + MTX achieved DAS28 (CRP) remission. 3 Week 24 Week 52 DAS28 remission rates were maintained through Week

10 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage MTX = methotrexate; DAS28 = Disease Activity Score 28; CRP = C-reactive protein; RA = rheumatoid arthritis; ACR = American College of Rheumatology; HAQ-DI = Health Assessment Questionnaire Disability Index. References 1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6): Erratum in: Ann Rheum Dis. 2011;70(1): SIMPONI.. March Keystone EC, et al. Ann Rheum Dis. 2010;69(6):

11 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the efficacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered subcutaneously every 4 weeks. Primary end points were the proportion of patients with 20% improvement in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24.

12 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage SIMPONI helps achieve early and sustained reduction in pre-erosive lesions 1,2,a,b Radiographic data for SIMPONI supported by MRI substudies 1,2 : In a substudy of GO-BEFORE (N=318), significant improvements in synovitis (P<0.001), osteitis (P<0.001), and bone erosions (P<0.05) vs placebo + MTX were observed as early as Week 12. 1,c In a substudy of GO-FORWARD (n=240), significant reductions in synovitis and osteitis vs MTX alone were observed despite low levels of disease activity in the total study population (P<0.001). 2,d Improvements in synovitis, osteitis, and bone erosions were maintained to Week Synovitis improvement RA MRI synovitis and bone marrow edema osteitis in early RA can predict later radiographic progression. 3

13 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

14 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

15 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

16 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

17 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

18 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

19 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

20 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

21 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Example of improvements in synovitis after treatment with SIMPONI e STIR Postcontrast T1 RA Baseline Week 12 Week 24

22 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage a Early defined as treatment response at Week 12. Sustained defined as maintained improvements at Week 24. b Pre-erosive = synovitis and osteitis. c GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active RA naïve to MTX. Radiographic progression was a primary end point. d GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) in patients with active RA despite MTX therapy. Primary end points were the proportion of patients with 20% improvement in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. e Please note that treatment with SIMPONI 100 mg should only be considered in patients weighing over 100 kg who have not achieved adequate clinical response with SIMPONI 50 mg. The increased risk of certain serious adverse drug reactions with the 100-mg dose compared with the 50-mg dose should be taken into account. MRI = magnetic resonance imaging; MTX = methotrexate; RA = rheumatoid arthritis; ACR = American College of Rheumatology; HAQ-DI = Health Assessment Questionnaire Disability Index. References 1. Østergaard M, et al. Arthritis Rheum. 2011;63(12): Conaghan PG, et al. Ann Rheum Dis. 2011;70(11): Boyesen P, et al. Ann Rheum Dis. 2011;70(3):

23 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage GO-FORWARD: MRI of the wrist at baseline, Week 12, and Week 24 of a patient randomized to receive SIMPONI 100 mg plus placebo. Coronal short tau inversion recovery (STIR) images (A C) show extensive bone edema at baseline (A). The bone edema has markedly decreased at Week 12 (B) and has nearly resolved at Week 24 (C). Corresponding postcontrast T1-weighted images with fat suppression (D F) show substantial synovitis at baseline (D) and markedly reduced synovitis at Week 12 (E) and Week 24 (F). Precontrast T1-weighted images without fat suppression (G I) show no progression of bone erosion during the 24-week follow-up period. Note: Series of consecutive images were evaluated; the images displayed here are representative but not exhaustive.

24 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage SIMPONI helps to significantly inhibit progression of structural damage 1 SIMPONI 50 mg + MTX significantly inhibited radiographic progression at Week 52 in previously MTX-naïve patients, as measured by SHS. 1 Nearly half the radiographic progression seen vs MTX alone. Benefits demonstrated even in patients with disease duration >3 years (established RA). In MTX-experienced patients with active disease, SIMPONI 50 mg + MTX significantly limited radiographic progression at Week 24 and reduced RA signs and symptoms as measured by ACR20 responses at Weeks 14 and MTX naive MTX experienced RA SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function leading to potential improvements in patient QoL. 3

25 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Change in SHS from baseline 1,2 RA MTX naïve (Week 52) a P=0.015 Mean change from baseline Placebo + MTX (n=160) 0.74 SIMPONI 50 mg monthly + MTX (n=159) MTX naive MTX experienced

26 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Change in SHS from baseline 1,2 RA MTX naïve (Week 52) a P=0.015 Mean change from baseline % less progression 1.37 Placebo + MTX (n=160) 0.74 SIMPONI 50 mg monthly + MTX (n=159) MTX naive MTX experienced

27 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Change in SHS from baseline 1,2 RA MTX experienced (Week 24) b P=0.020 Mean change from baseline Placebo + MTX (n=105) 1.05 SIMPONI 50 mg monthly + MTX (n=101) MTX naive MTX experienced

28 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage Change in SHS from baseline 1,2 RA MTX experienced (Week 24) b P=0.020 Mean change from baseline % less progression 2.51 Placebo + MTX (n=105) 1.05 SIMPONI 50 mg monthly + MTX (n=101) MTX naive MTX experienced

29 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage a Coprimary end point at Week 52. b Week 24 data. MTX = methotrexate; SHS = Sharp/van der Heijde score (higher SHS scores indicate greater radiographic progression); RA = rheumatoid arthritis; QoL = quality of life. References 1. Emery P, et al. Arthritis Rheum. 2011;63(5): Tanaka Y, et al. Ann Rheum Dis. 2011;Epub ahead of print. 3. SIMPONI.. March 2012.

30 EFFICACY Signs and symptoms of RA Clinical remission Pre-erosive lesions Structural damage GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active RA naïve to MTX. Radiographic progression was a primary end point. Tanaka, et al: a multicenter, randomized, double-blind, placebo-controlled study in Japanese patients (N=261) with active RA despite MTX therapy. Patients were randomized to SIMPONI 50 mg, SIMPONI 100 mg, or placebo, subcutaneously, every 4 weeks. The primary end point was the proportion of patients achieving ACR20 at Week 14. Radiographic progression was assessed by change from baseline in SHS at Week 24.

31 QoL Physical function Summary Effective once-monthly treatment that helps improve physical function and QoL 1,2 RA SIMPONI 50 mg + MTX significantly improved HAQ scores vs placebo + MTX 1,2 : HAQ scores were maintained through Week Significantly improved health-related QoL as measured by SF-36 physical component score. 3 HAQ

32 QoL Physical function SIMPONI (golimumab) Summary Improvement in HAQ from baseline RA Median improvement in HAQ-DI P< n=133 n=89 n=81 n=70 Week 24 Week 52 Placebo + MTX (switched to SIMPONI 50 mg monthly + MTX at Week 16) SIMPONI 50 mg + MTX

33 QoL Physical function SIMPONI (golimumab) Summary QoL = quality of life; MTX = methotrexate; HAQ = Health Assessment Questionnaire; HAQ-DI = HAQ Disability Index; RA = rheumatoid arthritis; ACR = American College of Rheumatology; SF-36 = Short Form-36 Health Survey. References 1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6): Erratum in: Ann Rheum Dis. 2011;70(1): Keystone EC, et al. Ann Rheum Dis. 2010;69(6): SIMPONI.. March 2012.

34 QoL Physical function SIMPONI (golimumab) Summary GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the efficacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered subcutaneously every 4 weeks. Primary end points were the proportion of patients with 20% improvement in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24.

35 QoL Physical function SIMPONI (golimumab) Summary Efficacy with monthly SC SIMPONI RA Reduced signs and symptoms 1 3 Provided proven clinical remission 2,3 Reduced disease activity 2,4 6

36 QoL Physical function Summary Efficacy with monthly SC SIMPONI RA Reduced signs and symptoms 1 3 Almost twice as many patients achieved an ACR50 response vs MTX alone ACR response maintained through 2 years Provided proven clinical remission 2,3 Reduced disease activity 2,4 6

37 QoL Physical function Summary Efficacy with monthly SC SIMPONI RA Reduced signs and symptoms 1 3 Almost twice as many patients achieved an ACR50 response vs MTX alone ACR response maintained through 2 years Provided proven clinical remission 2,3 DAS28 remission rates sustained through Week 52 and Week 104 Reduced disease activity 2,4 6

38 QoL Physical function Summary Efficacy with monthly SC SIMPONI RA Reduced signs and symptoms 1 3 Almost twice as many patients achieved an ACR50 response vs MTX alone ACR response maintained through 2 years Provided proven clinical remission 2,3 DAS28 remission rates sustained through Week 52 and Week 104 Reduced disease activity 2,4 6 Significantly reduced preerosive lesions Resulted in nearly half the radiographic progression vs MTX alone

39 QoL Physical function SIMPONI (golimumab) Summary ACR = American College of Rheumatology; MTX = methotrexate; SC = subcutaneous; DAS28 = Disease Activity Score 28 (DAS28 remission was compiled using C-reactive protein [CRP]); HAQ = Health Assessment Questionnaire; SF-36 = Short Form-36 Health Survey. References 1. Keystone EC, et al. Ann Rheum Dis. 2009;68(6): Erratum in: Ann Rheum Dis. 2011;70(1): SIMPONI.. March Keystone EC, et al. Ann Rheum Dis. 2010;69(6): Erratum in: Ann Rheum Dis. 2011;70(1): Østergaard M, et al. Arthritis Rheum. 2011;63(12): Conaghan PG, et al. Ann Rheum Dis. 2011;70(11): Emery P, et al. Arthritis Rheum. 2011;63(5):

40 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested Safety profile of SIMPONI after 3 years 1,2 RA In Phase 3 trials through 3 years 1 : 7.4% of patients receiving injections of SIMPONI 50 mg discontinued therapy because of adverse events vs 4.9% of those receiving placebo injections. SIMPONI has over 8 years of worldwide clinical trial experience and has been used in over 80,000 patients. 2,3 Adverse event data

41 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested An analysis of pooled data from the long-term extensions of randomized, double-blind, placebo-controlled studies in RA, PsA, and AS. 1 RA Adverse event 2 (Pooled data) SIMPONI 50 mg +/ MTX Placebo +/ MTX Patients treated (n) 1, Deaths a All serious infections a Tuberculosis (TB) a Opportunistic infections other than TB a Malignancy Nonmelanoma skin cancers Total patient-years of follow-up Incidence/100 patient-years Lymphoma Total patient-years of follow-up Incidence/100 patient-years Other malignancies Total patient-years of follow-up Incidence/100 patient-years 2, , , Includes SIMPONI SC Phase 2b studies in addition to Phase 3 RA, PsA, and AS studies.

42 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested a Incidence per 100 patient-years. RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; MTX = methotrexate. References 1. Kay J, et al. ACR 2011; abstract Data on file. MSD SIMPONI PSUR Accessed 31/01/12.

43 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested SIMPONI comprehensively tested in worldwide trials RA A comprehensive development program: Phase 3 clinical trials in over 2,300 rheumatology patients 1 6 Trial Indication Patient type Subjects, N GO-BEFORE Active RA MTX naïve 637 GO-FORWARD Active RA MTX nonresponders 444 GO-AFTER Active RA Anti-TNF experienced 461 GO-REVEAL GO-RAISE Active PsA Active AS DMARD nonresponders Conventional therapy nonresponders SIMPONI has been extensively tested in a worldwide clinical trial program in more than 2,300 patients, including different RA a patient groups, as well as those with PsA b or AS c. 1 6

44 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active RA naïve to MTX. Radiographic progression was a primary end point. ACR50 at Week 24 was a primary end point.

45 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered subcutaneously every 4 weeks. Primary end points were the proportion of patients with 20% improvement in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.

46 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-AFTER: a double-blind, placebo-controlled trial (N=461) to evaluate the efficacy and safety of SIMPONI in patients with active rheumatoid arthritis (RA) who had previously received one or more TNFα inhibitors. Patients with active RA were randomly assigned (1:1:1) to placebo or SIMPONI 50 mg or 100 mg. The primary end point was the proportion of patients who achieved 20% or higher improvement in ACR criteria for assessment of RA (ACR20) at Week 14. At Week 16, patients who had less than 20% improvement in tender and swollen joint counts were given rescue therapy in a double-blinded manner: patients in the placebo group received SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and patients in the SIMPONI 100-mg group continued to receive 100 mg.

47 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

48 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the efficacy and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or 100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the SC SIMPONI 100-mg group continued to receive 100 mg of SC SIMPONI. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.

49 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested a SIMPONI, in combination with MTX, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD therapy including MTX has been inadequate. the treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX. SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function. b SIMPONI, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. c SIMPONI is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy. RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis; DMARD = disease-modifying antirheumatic drug; AS = ankylosing spondylitis. References 1. SIMPONI.. March Keystone EC, et al. Ann Rheum Dis. 2009;68(6): Erratum in: Ann Rheum Dis. 2011;70(1): Emery P, et al. Arthritis Rheum. 2009;60(8): Erratum in: Arthritis Rheum. 2010;62(10): Smolen JS, et al. Lancet. 2009;374(9685): Inman RD, et al. Arthritis Rheum. 2008;58(11): Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8):2555.

50 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Convenience and features that fit with everyday life RA Developed for convenience with only 1 injection per month. 1 6 Features citric acid free formulation a and low injection volume (0.5 ml). 1 Low level of ISRs, including pain 1 : 5.8% of patients on SIMPONI (50 mg and 100 mg) experienced ISRs vs 2.2% on placebo. 1 Dosing information

51 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Citric acid free formulation a Injection volume RA Monthly SIMPONI autoinjector 50 mg Monthly SIMPONI prefilled syringe 50 mg Adalimumab autoinjector 40 mg and prefilled syringe 40 mg Etanercept autoinjector 50 mg Etanercept prefilled syringe 25 mg Certolizumab prefilled syringe 200 mg

52 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Citric acid free formulation a Injection volume RA Monthly SIMPONI autoinjector 50 mg 0.5 ml Monthly SIMPONI prefilled syringe 50 mg 0.5 ml Adalimumab autoinjector 40 mg and prefilled syringe 40 mg 0.8 ml Etanercept autoinjector 50 mg 1.0 ml Etanercept prefilled syringe 25 mg 0.5 ml Certolizumab prefilled syringe 200 mg 1.0 ml

53 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program a A comparison of injection media found that a solution containing citrate as a buffer caused more pain immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain than the control saline solution. 6 ISR = injection site reaction; SC = subcutaneous. References 1. SIMPONI.. March Humira.. January Enbrel.. September Cimzia.. December Jørgensen JT, et al. Ann Pharmacother. 1996;30(7 8): Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2): Brands mentioned are trademarks of their respective owners.

54 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per month Injections per year

55 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per month Injections per year

56 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per month Injections per year

57 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per month Injections per year

58 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per month Injections per year

59 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per month Injections per year

60 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per year Injections per month

61 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per year Injections per month

62 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per year Injections per month

63 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per year Injections per month

64 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per year Injections per month

65 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1-6 RA Injections per year Injections per month

66 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program References 1. SIMPONI.. March Humira.. January Enbrel.. September Cimzia.. December Jørgensen JT, et al. Ann Pharmacother. 1996;30(7 8): Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2): Brands mentioned are trademarks of their respective owners.

67 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program State-of-the-art SmartJect autoinjector pen RA Developed to help simplify administration Secure Autoretract needle Security seal Built-in safety sleeve Easy to administer 2 audible clicks Large observation window Easy to handle Easy-grip body Large side button Easy-twist cap In RA, SIMPONI has a recommended dose of 50 mg, in combination with MTX, given once a month, on the same date each month. 1 Also available as 0.5-mL, single-use prefilled syringe

68 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Convenient, single-use prefilled syringe RA Developed to help simplify administration Easy to handle Needle guard Thumb-sized plunger head Easy to administer Clear observation window Easy-to-read label Secure Sturdy needle cover Extra-fine needle In RA, SIMPONI has a recommended dose of 50 mg, in combination with MTX, given once a month, on the same date each month. 1 Also available as 0.5-mL, single-use, state-of-the-art SmartJect autoinjector pen

69 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program RA = rheumatoid arthritis; MTX = methotrexate. Reference 1. SIMPONI.. March 2012.

70 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Carefully tailored SIMPONI for Me patient support program RA Patient support program designed to complement the patient-doctor relationship: Developed to help give patients on therapy with SIMPONI the confidence they need to self-inject Personalized, ongoing educational advice and support Tailored to meet needs of treatment-naïve and biologic-experienced patients Program includes A starter kit Personalized monthly reminderto-inject service FREE help line Online information resource Registering for SIMPONI for Me Any patients with medical questions concerning their condition are advised to contact their health care professional.

71 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program RA How patients can register for SIMPONI for Me Complete and return enrollment form provided with starter kit Call SIMPONI for Me at < > Visit simponiforme.com

72 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Helps get patients back to everyday life in a monthly SC dose RA Proven and sustained clinical efficacy 1,2 Rigorous clinical trial program 1,3,4 Convenience and support 1 Clinical efficacy Clinical experience Convenience

73 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Helps get patients back to everyday life in a monthly SC dose RA Proven and sustained clinical efficacy 1,2 Provided sustained ACR50 response Achieved and maintained DAS28 remission Inhibited radiographic progression Significantly improved HAQ scores Rigorous clinical trial program 1,3,4 Convenience and support 1 Clinical efficacy Clinical experience Convenience

74 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Helps get patients back to everyday life in a monthly SC dose RA Proven and sustained clinical efficacy 1,2 Provided sustained ACR50 response Achieved and maintained DAS28 remission Inhibited radiographic progression Significantly improved HAQ scores Rigorous clinical trial program 1,3,4 Efficacy in RA demonstrated in three Phase 3 trials Over 8 years of worldwide clinical trial experience across indications Over 80,000 patients treated globally across indications Convenience and support 1 Clinical efficacy Clinical experience Convenience

75 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Helps get patients back to everyday life in a monthly SC dose RA Proven and sustained clinical efficacy 1,2 Provided sustained ACR50 response Achieved and maintained DAS28 remission Inhibited radiographic progression Significantly improved HAQ scores Rigorous clinical trial program 1,3,4 Efficacy in RA demonstrated in three Phase 3 trials Over 8 years of worldwide clinical trial experience across indications Over 80,000 patients treated globally across indications Convenience and support 1 Only SC anti-tnf with monthly dosing Choice of prefilled autoinjector pen or syringe Carefully tailored patient support program Clinical efficacy Clinical experience Convenience

76 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical efficacy RA Efficacy sustained through Week 52 with with more more than than half of patients achieving an ACR50 response Clinical efficacy times as many patients achieved DAS28 remission vs MTX alone (P<0.001) at Week Clinical experience Convenience Almost times more improvement in HAQ-DI scores vs placebo + MTX alone at Week 24 (P<0.001)

77 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical efficacy RA Efficacy sustained through Week 52 with more than half of patients achieving an ACR50 response Clinical efficacy times as many patients achieved DAS28 remission vs MTX alone (P<0.001) at Week Clinical experience Convenience Almost times more improvement in HAQ-DI scores vs placebo + MTX alone at Week 24 (P<0.001)

78 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical efficacy RA Efficacy sustained through Week 52 with more than half of patients achieving an ACR50 response. 5 Clinical efficacy 4 times as many patients achieved DAS28 remission vs MTX alone (P<0.001) at Week Clinical experience Convenience Almost times more improvement in HAQ-DI scores vs placebo + MTX alone at Week 24 (P<0.001)

79 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical efficacy RA Efficacy sustained through Week 52 with more than half of patients achieving an ACR50 response Clinical efficacy 4 times as many patients achieved DAS28 remission vs MTX alone (P<0.001) at Week Clinical experience Convenience Almost 3 times more improvement in HAQ-DI scores vs placebo + MTX alone at Week 24 (P<0.001)

80 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical experience RA Clinical efficacy Over patients treated globally. 3,4 70,000 80,000 90, ,000 Clinical experience Over years of clinical trial experience. 3, Convenience

81 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical experience RA Clinical efficacy Over 80,000 patients treated globally. 3,4 70,000 90, ,000 Clinical experience Over years of clinical trial experience. 3, Convenience

82 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical experience RA Clinical efficacy Over 80,000 patients treated globally. 3,4 70,000 90, ,000 Clinical experience Over 8 years of clinical trial experience. 3, Convenience

83 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Convenience RA Which of these products is NOT a citric acid free formulation? 1,6 10,a Clinical efficacy Monthly SIMPONI autoinjector 50 mg Monthly SIMPONI prefilled syringe 50 mg Adalimumab autoinjector 40 mg and prefilled syringe 40 mg Etanercept autoinjector 50 mg Clinical experience Convenience Etanercept prefilled syringe 25 mg Certolizumab prefilled syringe 200 mg

84 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Convenience RA Which of these products is NOT a citric acid free formulation? 1,6 10,a Monthly SIMPONI autoinjector 50 mg Monthly SIMPONI prefilled syringe 50 mg Adalimumab autoinjector 40 mg and prefilled syringe 40 mg Etanercept autoinjector 50 mg Etanercept prefilled syringe 25 mg Certolizumab prefilled syringe 200 mg Clinical efficacy Clinical experience Convenience

85 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) a A comparison of injection media found that a solution containing citrate as a buffer caused more pain immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain than the control saline solution. 10 SC = subcutaneous; RA = rheumatoid arthritis; TNF = tumor necrosis factor; ACR = American College of Rheumatology; MTX = methotrexate; DAS28 = Disease Activity Score 28; HAQ= Health Assessment Questionnaire; HAQ-DI = Health Assessment Questionnaire Disability Index. References 1. SIMPONI.. March Keystone EC, et al. Ann Rheum Dis. 2009;68(6): Erratum in: Ann Rheum Dis. 2011;70(1): Data on file. MSD SIMPONI PSUR Accessed 01/31/ Keystone EC, et al. Ann Rheum Dis. 2010;69(6): Humira.. January Enbrel.. September Cimzia.. December Jørgensen JT, et al. Ann Pharmacother. 1996;30(7 8): Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2): Brands mentioned are trademarks of their respective owners.

86 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) REMICADE provides an appropriate solution for patients with active, uncontrolled disease who are at risk of noncompliance and/or who have a preference for IV RA REMICADE helps you deliver rapid a relief, proven remission, and close management for patients with RA Improved quality of life 1 REMICADE rapid a relief, proven remission Improved signs and symptoms 2 Helped achieve biologic-free remission 3 Weight-based dose optimization 4 Helped prevent joint damage 5 In-office infusion allows for closer patient monitoring and support Patient profiles REMICADE offers speed a and power to help achieve sustained remission in early and established RA.

87 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) RA The patient High CRP levels Unable to understand and/ or follow treatment regimen The patient at risk with active, uncontrolled Signs of erosive disease Unwilling or unable to self-inject of noncompliance or who prefers disease High inflamed joint count Needs the reassurance of regular contact with an HCP IV treatment

88 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) IV = intravenous; RA = rheumatoid arthritis; CRP = C-reactive protein; HCP = health care professional. References 1. Klarenbeek NB, et al. Ann Rheum Dis. 2011;70(6): Maini R, et al. Lancet. 1999;354(9194): Van der Kooij SM, et al. Ann Rheum Dis. 2009;68(6): REMICADE.. March St Clair EW, et al. Arthritis Rheum. 2004;50(11):

89 RA Rheumatoid arthritis PsA Psoriatic arthritis AS Ankylosing spondylitis EFFICACY EFFICACY EFFICACY QoL QoL QoL SAFETY SAFETY SAFETY EXPERIENCE EXPERIENCE EXPERIENCE SUMMARY SUMMARY SUMMARY Copyright 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved. RHEU /13

90 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps to provide proven reduction in disease activity in PsA patients 1,2 PsA SIMPONI 50 mg significantly reduced signs and symptoms across all ACR criteria 1,2 : ACR response at Week 14 1,2 The safety profile of SIMPONI in PsA was consistent with that of other anti-tnf agents. 2 Patients, % P < P < ACR20 ACR50 ACR70 P < Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n = 113) SIMPONI 50 mg (n = 292) Week 14 Week 24 Week 52 Week 104

91 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps to provide proven reduction in disease activity in PsA patients 1,2 PsA SIMPONI 50 mg significantly reduced signs and symptoms across all ACR criteria 1,2 : ACR response at Week 24 1,2 The safety profile of SIMPONI in PsA was consistent with that of other anti-tnf agents. 2 Patients, % P < P < ACR20 ACR50 ACR70 P < Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n = 113) SIMPONI 50 mg (n = 292) Week 14 Week 52 Week 104

92 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps to provide proven reduction in disease activity in PsA patients 1,2 PsA SIMPONI 50 mg significantly reduced signs and symptoms across all ACR criteria 1,2 : ACR response at Week The safety profile of SIMPONI in PsA was consistent with that of other anti-tnf agents. 2 Patients, % ACR20 ACR50 ACR70 Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n =113) SIMPONI 50 mg (n=146) Week 14 Week 24 Week 52 Week 104

93 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps to provide proven reduction in disease activity in PsA patients 1,2 PsA SIMPONI 50 mg significantly reduced signs and symptoms across all ACR criteria 1,2 : The safety profile of SIMPONI in PsA was consistent with that of other anti-tnf agents. 2 Clinical improvements across all ACR criteria were maintained through Week Week 14 Week 24 Week 52 Week 104

94 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA PsA = psoriatic arthritis; ACR = American College of Rheumatology; SC = subcutaneous; TNF = tumor necrosis factor. References 1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8): SIMPONI.. March Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: /art [Epub ahead of print]

95 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

96 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps provide proven reduction in disease activity in PsA patients 1, 2 PsA SIMPONI helped achieve a significant improvement in DAS28 scores at Week 24 (P<0.001) 1,a DAS28 scores at Week 24 1,a Improvements in DAS Placebo (n=113) P < SIMPONI 50 mg monthly (n=146) DAS28 scores were maintained through 2 years. 2 Week 52 Week 104

97 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps provide proven reduction in disease activity in PsA patients 1,2 PsA SIMPONI helped achieve a significant improvement in DAS28 scores at Week 24 (P<0.001) 1,a DAS28-CRP response of good/moderate was achieved by 82% of patients treated with DAS28 scores were maintained through 2 years. 2 SIMPONI 50 mg at Week Week 24 Week 52 Week 104

98 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps provide proven reduction in disease activity in PsA patients 1,2 PsA SIMPONI helped achieve a significant improvement in DAS28 scores at Week 24 (P<0.001) 1,a DAS28 scores were maintained through 2 years. 2 Week 24 Week 52 Week 104

99 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA a DAS28 remission was compiled using CRP; lower score equals improvement. PsA = psoriatic arthritis; DAS28 = Disease Activity Score 28; CRP = C-reactive protein; SC = subcutaneous; ACR = American College of Rheumatology. References 1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8): SIMPONI.. March Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: /art [Epub ahead of print]

100 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N= 405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

101 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps inhibit structural damage in active PsA PsA Helps prevent long-term damage SIMPONI significantly inhibited structural damage in active PsA through Week 24 ( 0.16 vs 0.27 for placebo; P= 0.011). 1 Prevention of structural damage was maintained through Week 52 and Week 104, with 77% of patients experiencing no progression from baseline. 1 Radiographic progression

102 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA Change in radiographic progression to Week 24 1,2 PsA Mean change in SHS from baseline Weeks Weeks 0.0 Placebo (n=113) SIMPONI 50 mg monthly (n=146) Week 0 Week 24 Week 52

103 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA Change in radiographic progression to Week 24 1,2 PsA Mean change in SHS from baseline Weeks 0.27 P= Weeks All patients randomized to placebo received SIMPONI 50 mg monthly from Week 24 Placebo (n =113) SIMPONI 50 mg monthly (n=146) Week 0 Week 24 Week 52

104 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA Change in radiographic progression to Week 52 1,2 PsA Mean change in SHS from baseline Weeks Weeks Placebo (n =113) SIMPONI 50 mg monthly (n=146) Week 0 Week 24 Week 52

105 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA PsA = psoriatic arthritis; SHS = Sharp/van der Heijde score; SC = subcutaneous; ACR = American College of Rheumatology. References 1. SIMPONI.. March Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: /art [Epub ahead of print]

106 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from Week 24 through Week 104. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14. Radiographs of the hands and feet were obtained at Weeks 0, 24, 52, and 104.

107 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps improve signs and symptoms of psoriasis PsA SIMPONI helped to significantly reduce severity of skin psoriasis a (PASI50, 75, and 90; P<0.001) 1 Patients, % Improvement in PASI scores at Week P < PASI50 PASI75 PASI90 Placebo (n=113) SIMPONI 50 mg monthly (n=146) P < P < Nail appearance Week 24 Week 52

108 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps improve signs and symptoms of psoriasis PsA SIMPONI helped to significantly reduce severity of skin psoriasis a (PASI50, 75, and 90; P<0.001) 1 Improvement in PASI75 score at Week 52 2 Patients, % Nail appearance 0 Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=113) SIMPONI 50 mg monthly (n=146) Week 24

109 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA a Among the 74% of patients in whom 3% of body surface area was affected by psoriasis at baseline. PASI = Psoriasis Area and Severity Index; PsA = psoriatic arthritis; SC = subcutaneous; ACR = American College of Rheumatology. References 1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8): Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: /art [Epub ahead of print]

110 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from Week 24 through Week 52. The study was unblinded at Week 52. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

111 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps restore normal appearance to nails 1 SIMPONI helped to significantly improve psoriatic nail disease as measured by NAPSI (P=0.015 Week 14; P<0.001 Week 24) 1 : NAPSI improvements were sustained through Week Median change in NAPSI score, % Improvement in NAPSI score P= Week 14 Week 24 P< Placebo (n=113) SIMPONI 50 mg monthly (n=146)

112 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA NAPSI = Nail Psoriasis Severity Index; PsA = psoriatic arthritis; SC = subcutaneous; ACR = American College of Rheumatology. References 1. Kavanaugh A, et al. Arthritis Rheum. 2009;60: Erratum in: Arthritis Rheum. 2010;62(8): Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: /art [Epub ahead of print]

113 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

114 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA SIMPONI helps reduce the signs and symptoms of enthesitis PsA In GO-REVEAL, SIMPONI significantly improved enthesitis and reduced the proportion of patients with enthesitis vs placebo at Week 24 1,a : 5 times greater improvement in PsA-modified MASES score vs placebo at Week 24 (60% vs 12%, P<0.001) SIMPONI has shown significant efficacy against most of the manifestations associated with PsA. 1 4

115 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks through Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

116 Signs and symptoms EFFICACY Disease activity Structural damage Signs of psoriasis Enthesitis of PsA a SIMPONI 50 mg monthly. MASES = Maastricht Ankylosing Spondylitis Enthesitis Score; PsA = psoriatic arthritis; SC = subcutaneous; ACR = American College of Rheumatology. References 1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8): Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: /art [Epub ahead of print] 3. Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9): SIMPONI.. March 2012.

117 QoL Improved QoL SIMPONI (golimumab) Summary SIMPONI helps improve patient QoL PsA 10 times more improvement in QoL score with SIMPONI 50 mg vs placebo 1 : Mean improvement in PCS component of SF36 of 6.5 in the group receiving SIMPONI 50 mg vs 0.6 for placebo at Week 14 (P<0.001). Improvement was maintained through Week Improvement in QoL Safety profile Mean change from baseline in SF36 PCS score P< Week 14 Week Placebo (n=113) SIMPONI 50 mg monthly (n=146)

118 QoL Improved QoL Summary PsA Safety profile through Week 52: Safety findings through Week 52 were consistent with Week 24 results and with other biologic agents, including anti-tnf agents. 2 The most commonly reported AEs at Weeks 24 and 52 were respiratory infections and nasopharyngitis (at Week 24, 9% SIMPONI vs 6% placebo, and 9% SIMPONI vs 4% placebo, respectively). 1,2 No patient developed active tuberculosis or an opportunistic infection through Week % of the group receiving SIMPONI and 4% of the placebo group discontinued treatment before Week ISRs occurred in 3% of the groups receiving either placebo or SIMPONI at Week 24. No ISR was severe, serious, or resulted in discontinuation of treatment. 1

119 QoL Improved QoL SIMPONI (golimumab) Summary GO-REVEAL: a multicenter, randomized, double-blind, placebo-controlled study (N = 405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks through Week 20. All patients, including those randomized to placebo, received SIMPONI from Week 24 through Week 52. The study was unblinded at Week 52. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

120 QoL Improved QoL SIMPONI (golimumab) Summary QoL = quality of life; SF36 PCS = Short Form-36 physical component summary score; PsA = psoriatic arthritis; SC = subcutaneous; ACR = American College of Rheumatology; TNF = tumor necrosis factor; AE = adverse event; ISR = injection site reaction. References 1. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8): Kavanaugh A, et al. Arthritis Rheum. 2012; Feb 29 doi: /art [Epub ahead of print]

121 QoL Improved QoL Summary Efficacy with monthly SC SIMPONI PsA Reduced signs and symptoms 1,2 Reduced disease activity 1,2 Improved most PsA-associated comorbidities 2,3

122 QoL Improved QoL Summary Efficacy with monthly SC SIMPONI PsA Reduced signs and symptoms 1,2 8 times more patients achieved an ACR50 response at Week 24 a ACR response maintained through 2 years b Reduced disease activity 1,2 Improved most PsA-associated comorbidities 2,3

123 QoL Improved QoL Summary Efficacy with monthly SC SIMPONI PsA Reduced signs and symptoms 1,2 8 times more patients achieved an ACR50 response at Week 24 a ACR response maintained through 2 years b Reduced disease activity 1,2 Significant improvement in DAS28 scores at Week 24, maintained over 2 years Helped to prevent structural damage through Week 52 and Week 104 to help maintain everyday functioning Improved most PsA-associated comorbidities 2,3

124 QoL Improved QoL Summary Efficacy with monthly SC SIMPONI PsA Reduced signs and symptoms 1,2 8 times more patients achieved an ACR50 response at Week 24 a ACR response maintained through 2 years b Reduced disease activity 1,2 Significant improvement in DAS28 scores at Week 24, maintained over 2 years Helped to prevent structural damage through Week 52 and Week 104 to help maintain everyday functioning Improved most PsA-associated comorbidities 2,3 Significant improvement in skin response (PASI), nail disease (NAPSI), and enthesitis (PsA-modified MASES)

125 QoL Improved QoL SIMPONI (golimumab) Summary a ACR50 response at Week 24: 32% for SIMPONI 50 mg vs 4% for placebo. b ACR50 response at Week 104 of 46% for SIMPONI 50 mg. ACR = American College of Rheumatology; PsA = psoriatic arthritis; PASI = Psoriasis Area and Severity Index; NAPSI = Nail Psoriasis Severity Index; MASES = Maastricht Ankylosing Spondylitis Enthesitis Score; DAS28 = Disease Activity Score 28; SC = subcutaneous; SF36 PCS = Short Form-36 physical component summary score. References 1. SIMPONI.. March Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8): Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):

126 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested Safety profile of SIMPONI after 3 years 1,2 PsA In Phase 3 trials through 3 years 1 : 7.4% of patients receiving injections of SIMPONI 50 mg discontinued therapy because of adverse events vs 4.9% of those receiving placebo injections. SIMPONI has over 8 years of worldwide clinical trial experience and has been used in over 80,000 patients. 2,3 Adverse event data

127 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested An analysis of pooled data from the long-term extensions of randomized, double-blind, placebo-controlled studies in AS, RA, and PsA 1 : PsA Adverse event 2 (Pooled data) SIMPONI 50 mg +/ MTX Placebo +/ MTX Patients treated (n) 1, Deaths a All serious infections a Tuberculosis (TB) a Opportunistic infections other than TB a Malignancy Nonmelanoma skin cancers Total patient-years of follow-up Incidence/100 patient-years Lymphoma Total patient-years of follow-up Incidence/100 patient-years Other malignancies Total patient-years of follow-up Incidence/100 patient-years 2, , , Includes SIMPONI SC Phase 2b studies in addition to Phase 3 AS, RA, and PsA.

128 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested a Incidence per 100 patient-years. MTX = methotrexate; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis. References 1. Kay J, et al. ACR 2011; abstract Data on file. MSD SIMPONI PSUR Accessed 01/31/12.

129 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested SIMPONI comprehensively tested in worldwide trials PsA A comprehensive development program: Phase 3 clinical trials in over 2,300 rheumatology patients 1 6 Trial Indication Patient type Subjects, N GO-BEFORE Active RA a MTX naïve 637 GO-FORWARD Active RA a MTX nonresponders 444 GO-AFTER Active RA a Anti-TNF experienced 461 GO-REVEAL Active PsA b DMARD nonresponders GO-RAISE Active AS c Conventional therapy nonresponders SIMPONI has been extensively tested in a worldwide clinical trial program in more than 2,300 patients, including different RA a patient groups, as well as those with PsA b or AS c. 1 6

130 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-BEFORE: a multicenter, randomized, double-blind, placebo-controlled study (N= 637) in patients with active RA naïve to MTX. Radiographic progression was a primary end point. ACR50 at Week 24 was a primary end point.

131 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-FORWARD: a multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered subcutaneously every 4 weeks. Primary end points were the proportion of patients with 20% improvement in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.

132 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-AFTER: a multicenter, double-blind, placebo-controlled Phase III trial (N=461) to evaluate the efficacy and safety of SIMPONI in patients with active rheumatoid arthritis (RA) who had previously received one or more TNFα inhibitors. Patients with active RA were randomly assigned (1:1:1) to placebo, SIMPONI 50 mg, or SIMPONI 100 mg. The primary end point was the proportion of patients who achieved 20% or higher improvement in ACR criteria for assessment of RA (ACR20) at Week 14. At Week 16, patients who had <20% improvement in tender and swollen joint counts were given rescue therapy in a double-blinded manner: patients in the placebo group received SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and patients in the SIMPONI 100-mg group continued to receive 100 mg.

133 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-REVEAL: a randomized, double-blind, placebo-controlled study (N=405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

134 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the efficacy and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or 100 mg or placebo, every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group were switched in Week 24 to SC SIMPONI 50 mg.

135 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested a SIMPONI, in combination with MTX, is indicated for: The treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD therapy including MTX has been inadequate. The treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX. SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function. b SIMPONI, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. c SIMPONI is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy. RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis; DMARD = disease-modifying antirheumatic drug; AS = ankylosing spondylitis. References 1. SIMPONI.. March Keystone EC, et al. Ann Rheum Dis. 2009;68(6): Erratum in: Ann Rheum Dis. 2011;70(1): Emery P, et al. Arthritis Rheum. 2009;60(8): Erratum in: Arthritis Rheum. 2010;62(10): Smolen JS, et al. Lancet. 2009;374(9685): Inman RD, et al. Arthritis Rheum. 2008;58(11): Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8):2555.

136 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Convenience and features that fit with everyday life PsA Developed for convenience with only 1 injection per month. 1 5 Features citric acid free formulation a and low injection volume (0.5 ml). 1 Low level of ISRs, including pain: 5.8% of patients on SIMPONI (50 mg and 100 mg) experienced ISRs vs 2.2% on placebo. 1 Dosing information

137 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Citric acid free formulation a Injection volume PsA Monthly SIMPONI autoinjector 50 mg Monthly SIMPONI prefilled syringe 50 mg Adalimumab autoinjector 40 mg and prefilled syringe 40 mg Etanercept autoinjector 50 mg Etanercept prefilled syringe 25 mg

138 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Citric acid free formulation a Injection volume PsA Monthly SIMPONI autoinjector 50 mg 0.5 ml Monthly SIMPONI prefilled syringe 50 mg 0.5 ml Adalimumab autoinjector 40 mg and prefilled syringe 40 mg 0.8 ml Etanercept autoinjector 50 mg 1.0 ml Etanercept prefilled syringe 25 mg 0.5 ml

139 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program a A comparison of injection media found that a solution containing citrate as a buffer caused more pain immediately after SC injection than did a solution with histidine as buffer, which did not cause more pain than the control saline solution. 5 ISR = injection site reaction; SC=subcutaneous. References 1. SIMPONI.. March Humira.. January Enbrel.. September Jørgensen JT, et al. Ann Pharmacother. 1996;30(7 8): Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2): Brands mentioned are trademarks of their respective owners.

140 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per month Injections per year

141 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per month Injections per year

142 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per month Injections per year

143 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per month Injections per year

144 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per month Injections per year

145 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per year Injections per month

146 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per year Injections per month

147 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per year Injections per month

148 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per year Injections per month

149 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Only SC anti-tnf with monthly dosing 1 5 PsA Injections per year Injections per month

150 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program References 1. SIMPONI.. March Humira.. January Enbrel.. September Jørgensen JT, et al. Ann Pharmacother. 1996;30(7 8): Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2): Brands mentioned are trademarks of their respective owners

151 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program State-of-the-art SmartJect autoinjector pen PsA Developed to help simplify administration Secure Autoretract needle Security seal Built-in safety sleeve Easy to administer 2 audible clicks Large observation window Easy to handle Easy-grip body Large side button Easy-twist cap In PsA, SIMPONI 50 mg is given once a month, on the same date each month. 1 Also available as 0.5-mL, single-use prefilled syringe

152 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Convenient, single-use prefilled syringe PsA Developed to help simplify administration Easy to handle Needle guard Thumb-sized plunger head Easy to administer Clear observation window Easy-to-read label Secure Sturdy needle cover Extra-fine needle In PsA, SIMPONI 50 mg is given once a month, on the same date each month. 1 Also available as 0.5-mL, single-use, state-of-the-art SmartJect autoinjector pen

153 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program PsA = psoriatic arthritis. Reference 1. SIMPONI.. March 2012.

154 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program Carefully tailored SIMPONI for Me patient support program PsA Patient support program designed to complement the patient doctor relationship: Developed to help give patients on therapy with SIMPONI the confidence they need to self-inject Personalized, ongoing educational advice and support Tailored to meet needs of treatment-naïve and biologic-experienced patients Program includes A starter kit Personalized monthly reminderto-inject service FREE help line Online information resource Registering for SIMPONI for Me Any patients with medical questions concerning their condition are advised to contact their health care professional.

155 EXPERIENCE Convenience Monthly dosing State-of-the-art devices Patient support program PsA How patients can register for SIMPONI for Me Complete and return enrollment form provided with starter kit Call SIMPONI for Me at < > Visit simponiforme.com

156 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Helps get patients back to everyday life in a monthly SC dose PsA Proven and sustained clinical efficacy 1 3 Rigorous clinical trial program 1 Convenience and support 1 Clinical efficacy Safety Convenience

157 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Helps get patients back to everyday life in a monthly SC dose PsA Proven and sustained clinical efficacy 1 3 Sustained improvements in ACR response criteria Efficacy against key manifestations associated with PsA, including skin and nail disease Improved QoL Rigorous clinical trial program 1 Convenience and support 1 Clinical efficacy Safety Convenience

158 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Helps get patients back to everyday life in a monthly SC dose PsA Proven and sustained clinical efficacy 1 3 Sustained improvements in ACR response criteria Efficacy against key manifestations associated with PsA, including skin and nail disease Improved QoL Rigorous clinical trial program 1 Approval for PsA, RA, and AS at launch Trials in wide range of patient types and treatment experience Convenience and support 1 Clinical efficacy Safety Convenience

159 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Helps get patients back to everyday life in a monthly SC dose PsA Proven and sustained clinical efficacy 1 3 Sustained improvements in ACR response criteria Efficacy against key manifestations associated with PsA, including skin and nail disease Improved QoL Rigorous clinical trial program 1 Approval for PsA, RA, and AS at launch Trials in wide range of patient types and treatment experience Convenience and support 1 Only SC anti-tnf with monthly dosing Carefully tailored patient support program Clinical efficacy Safety Convenience

160 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical efficacy PsA Clinical improvements across all ACR criteria were maintained through Week Clinical efficacy Prevention of structural damage was maintained through Week 52 and Week 104, with % of patients experiencing no progression from baseline Clinical experience Convenience times more improvement in QoL score with SIMPONI 50 mg vs placebo

161 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical efficacy PsA Clinical improvements across all ACR criteria were maintained through Week Clinical efficacy Prevention of structural damage was maintained through Week 52 and Week 104, with % of patients experiencing no progression from baseline Clinical experience Convenience times more improvement in QoL score with SIMPONI 50 mg vs placebo

162 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical efficacy PsA Clinical improvements across all ACR criteria were maintained through Week Clinical efficacy Prevention of structural damage was maintained through Week 52 and Week 104, with 77% of patients experiencing no progression from baseline Clinical experience Convenience times more improvement in QoL score with SIMPONI 50 mg vs placebo

163 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical efficacy PsA Clinical improvements across all ACR criteria were maintained through Week Clinical efficacy Prevention of structural damage was maintained through Week 52 and Week 104, with 77% of patients experiencing no progression from baseline Clinical experience Convenience 10 times more improvement in QoL score with SIMPONI 50 mg vs placebo

164 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical experience PsA Clinical efficacy Over patients treated globally. 4,5 70,000 80,000 90, ,000 Clinical experience Over years of clinical trial experience. 4, Convenience

165 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical experience PsA Clinical efficacy Over 80,000 patients treated globally. 4,5 70,000 90, ,000 Clinical experience Over years of clinical trial experience. 4, Convenience

166 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Clinical experience PsA Clinical efficacy Over 80,000 patients treated globally. 4,5 70,000 90, ,000 Clinical experience Over 8 years of clinical trial experience. 4, Convenience

167 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Convenience PsA Which of these products is NOT a citric acid free formulation? 1,6 9,a Clinical efficacy Monthly SIMPONI autoinjector 50 mg Monthly SIMPONI prefilled syringe 50 mg Adalimumab autoinjector 40 mg and prefilled syringe 40 mg Etanercept autoinjector 50 mg Clinical experience Convenience Etanercept prefilled syringe 25 mg

168 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) Convenience PsA Which of these products is NOT a citric acid free formulation? 1,6 9,a Monthly SIMPONI autoinjector 50 mg Monthly SIMPONI prefilled syringe 50 mg Adalimumab autoinjector 40 mg and prefilled syringe 40 mg Etanercept autoinjector 50 mg Etanercept prefilled syringe 25 mg Clinical efficacy Clinical experience Convenience

169 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) a A comparison of injection media found that a solution containing citrate as a buffer caused more pain immediately after SC injection than did a solution with histidine as a buffer, which did not cause more pain than the control saline solution. 9 SC = subcutaneous; ACR = American College of Rheumatology; QoL = quality of life; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis; TNF = tumor necrosis factor. References 1. SIMPONI.. March Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8): Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9): Data on file. MSD SIMPONI PSUR Humira.. January Enbrel.. September Jørgensen JT, et al. Ann Pharmacother. 1996;30(7 8): Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2): Brands mentioned are trademarks of their respective owners

170 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) REMICADE provides an appropriate solution for patients with high disease activity who are at risk of noncompliance and/or have a preference for IV REMICADE helps you deliver rapid a relief, sustained improvement, and close management for patients with PsA PsA REMICADE: rapid a relief, proven remission Rapid a relief of articular symptoms 1 3 Improvements in PsA manifestations 2 6 Sustained improvement in structural damage 7 Long-term inhibition of radiographic progression 8 Recommended by GRAPPA for all PsA manifestations 9 In-office infusion allows for closer patient monitoring and support Patient profiles REMICADE offers speed a and power to help achieve sustained remission in early and established PsA.

171 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) PsA The patient High CRP levels Unable to understand and/ or follow treatment regimen The patient at risk with active, uncontrolled Signs of erosive disease Unwilling or unable to self-inject of noncompliance or who prefers disease High inflamed joint count Needs the reassurance of regular contact with an HCP IV treatment

172 SUMMARY SIMPONI SIMPONI (golimumab) REMICADE (infliximab) a Rapid and speed are defined as response by Week 2. IV = intravenous; GRAPPA = Group for Research and Assessment of Psoriasis and Psoriatic Arthritis; PsA = psoriatic arthritis. References 1. Baranauskaite A, et al. Ann Rheum Dis. 2012;71(4): Antoni C, et al. Arthritis Rheum. 2005;52(4): Antoni C, et al. J Rheumatol. 2008;35(5): Reich K, et al. Lancet. 2005;366(9494); Antoni C, et al. Ann Rheum Dis. 2005;64(8): Kavanaugh A, et al. Ann Rheum Dis. 2007;66(4): Van der Heijde D, et al. Ann Rheum Dis. 2007;56(8); Kavanaugh A, et al. Ann Rheum Dis. 2006;65(8): Ritchlin CT, et al. Ann Rheum Dis. 2009;68(9):

173 RA Rheumatoid arthritis PsA Psoriatic arthritis AS Ankylosing spondylitis EFFICACY EFFICACY EFFICACY QoL QoL QoL SAFETY SAFETY SAFETY EXPERIENCE EXPERIENCE EXPERIENCE SUMMARY SUMMARY SUMMARY Copyright 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. All rights reserved. RHEU /13

174 EFFICACY Signs and symptoms Functioning Spinal inflammation SIMPONI helps to significantly reduce signs and symptoms of AS AS SIMPONI 50 mg helped achieve a greater ASAS20 response 4 weeks after the first injection vs placebo 1 : 59% of patients receiving SIMPONI 50 mg achieved the primary end point of an ASAS20 response vs 22% of placebo patients by Week 14 (P<0.001). 1,2 ASAS40 response data Clinical improvements in ASAS20 and ASAS40 were maintained through 2 years, and 32% of patients receiving SIMPONI 50 mg were in ASAS partial remission. 3

175 EFFICACY Signs and symptoms Functioning Spinal inflammation ASAS40 response at Week PE EE XO 100 AS 80 Patients, % Week Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

176 EFFICACY Signs and symptoms Functioning Spinal inflammation ASAS40 response at Week PE EE XO 100 AS 80 Patients, % ASAS40 response at Week 4 1 Greater proportions of patients in the SIMPONI groups achieved an ASAS40 response 4 weeks after the first injection. 0 Week Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

177 EFFICACY Signs and symptoms Functioning Spinal inflammation ASAS40 response at Week PE EE XO 100 AS Patients, % ASAS40 response at Week % of SIMPONI patients 15.4% of placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24) 0 Week Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

178 EFFICACY Signs and symptoms Functioning Spinal inflammation ASAS40 response at Week PE EE XO 100 AS Patients, % ASAS40 response at Week % of SIMPONI I patients 48% of placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24) 0 Week Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

179 EFFICACY Signs and symptoms Functioning Spinal inflammation ASAS40 response at Week PE EE XO 100 AS Patients, % ASAS40 response at Week % of SIMPONI patients ts 79% of placebo patients t (switched to SIMPONI 50 mg at Week 16 or Week 24) 0 Week Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

180 EFFICACY Signs and symptoms Functioning Spinal inflammation AS = ankylosing spondylitis; ASAS = ASsessment in AS international working group criteria; PE = primary endpoint; EE = early escape; XO = crossover; SC = subcutaneous. References 1. Inman RD, et al. Arthritis Rheum. 2008;58(11): SIMPONI.. March Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.

181 EFFICACY Signs and symptoms Functioning Spinal inflammation GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the efficacy and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or 100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. Observed data are presented without imputation. At Week 16, patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.

182 EFFICACY Signs and symptoms Functioning Spinal inflammation SIMPONI helps to achieve sustained improvements in functioning, pain, and stiffness over time AS SIMPONI 50 mg helped improve disease activity (BASDAI50) and physical function (BASFI) scores at Week 24 vs placebo (P<0.001) 1 : Half of patients achieved BASDAI50 at Week 24 (51% vs 15% placebo; P<0.001). 1 BASDAI50 response data Clinical improvements in disease activity and physical function were maintained through 2 years with SIMPONI 50 mg (both <3 at Week 104). 2 BASFI response data

183 EFFICACY Signs and symptoms Functioning Spinal inflammation BASDAI50 response at Week PE EE XO 10 AS Mean BASDAI score Week BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

184 EFFICACY Signs and symptoms Functioning Spinal inflammation BASDAI50 response at Week PE EE XO 10 AS Mean BASDAI score Week BASDAI50 response at Week 4 2 A greater proportion of patients in the SIMPONI group achieved a 50% improvement in BASDAI score 4 weeks after the first injection BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

185 EFFICACY Signs and symptoms Functioning Spinal inflammation BASDAI50 response at Week PE EE XO 10 AS Mean BASDAI score Week BASDAI50 response at Week % of SIMPONI patients 15.4% of placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24) BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

186 EFFICACY Signs and symptoms Functioning Spinal inflammation BASDAI50 response at Week PE EE XO 10 AS Mean BASDAI score Week BASDAI50 response at Week % of SIMPONI patients 50% of placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24) BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 104

187 EFFICACY Signs and symptoms Functioning Spinal inflammation BASDAI50 response at Week PE EE XO 10 AS Mean BASDAI score Week BASDAI50 response at Week % of SIMPONI patients 74% of placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24) BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

188 EFFICACY Signs and symptoms Functioning Spinal inflammation BASFI response at Week PE EE XO 10 AS Mean BASFI score Week BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

189 EFFICACY Signs and symptoms Functioning Spinal inflammation BASFI response at Week PE EE XO 10 AS Mean BASFI score Week BASFI response at Week 4 1 More patients in the SIMPONI group achieved improvements in BASFI scores 4 weeks after the first injection BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

190 EFFICACY Signs and symptoms Functioning Spinal inflammation BASFI response at Week PE EE XO 10 AS Mean BASFI score Week BASFI response at Week SIMPONI patients 5.0 placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24) BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

191 EFFICACY Signs and symptoms Functioning Spinal inflammation BASFI response at Week PE EE XO 10 AS Mean BASFI score Week BASFI response at Week 28 2 Patients who switched from placebo to SIMPONI experienced substantial improvement ment in BASFI within 4 12 weeks BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

192 EFFICACY Signs and symptoms Functioning Spinal inflammation BASFI response at Week PE EE XO 10 AS Mean BASFI score Week BASFI response at Week SIMPONI maintained ne BASFI response from Week 52 to Week BASDAI50 response data BASFI response data Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=107 at Week 104) Week 4 Week 14 Week 28 Week 104

193 EFFICACY Signs and symptoms Functioning Spinal inflammation BASDAI = Bath AS Disease Activity Index; BASFI = Bath AS Functional Index; PE = primary endpoint; EE = early escape; XO = crossover; AS = ankylosing spondylitis. References 1. Inman RD, et al. Arthritis Rheum. 2008;58(11): Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.

194 EFFICACY Signs and symptoms Functioning Spinal inflammation GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the efficacy and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or 100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. Observed data are presented without imputation. At Week 16, patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.

195 EFFICACY Signs and symptoms Functioning Spinal inflammation SIMPONI helps achieve improvement in spinal inflammation 1 AS SIMPONI 50 mg helped achieve a significant improvement in MRI-detected spinal inflammation 1 : 5.9 reduction in mean ASspiMRI-a score with SIMPONI vs 2.5 with placebo at Week 14 (P<0.05). 59% of patients receiving SIMPONI 50 mg with inflammation at baseline demonstrated minimal inflammation at Week MRI data Improvements in MRI-detected spinal inflammation were sustained through Week 104 with a mean reduction in ASspiMRI-a score of

196 EFFICACY Signs and symptoms Functioning Spinal inflammation Changes in MRI-detected spinal inflammation 1,a AS MRI scan at baseline Active lesions at multiple vertebral units (C7/T1 and T6/T7) MRI scan at Week 14 MRI scan at Week 104

197 EFFICACY Signs and symptoms Functioning Spinal inflammation Changes in MRI-detected spinal inflammation 1,a AS MRI scan at baseline Active lesions at multiple vertebral units (C7/T1 and T6/T7) MRI scan at Week 14 Spinal activity markedly decreased MRI scan at Week 104

198 EFFICACY Signs and symptoms Functioning Spinal inflammation Changes in MRI-detected spinal inflammation 1,a AS MRI scan at baseline Active lesions at multiple vertebral units (C7/T1 and T6/T7) MRI scan at Week 14 Spinal activity markedly decreased MRI scan at Week 104 Spinal activity almost fully resolved

199 EFFICACY Signs and symptoms Functioning Spinal inflammation a Please note that treatment with SIMPONI 100 mg should only be considered in patients weighing over 100 kg who have not achieved adequate clinical response with SIMPONI 50 mg. The increased risk of certain serious adverse drug reactions with the 100-mg dose compared with the 50-mg dose should be taken into account. MRI = magnetic resonance imaging; ASspiMRI-a = AS spine MRI-activity (assesses the presence of bone marrow edema but not the degree of edema); AS = ankylosing spondylitis; SC = subcutaneous; ASAS = assessment in AS international working group criteria. Reference 1. Braun J, et al. Ann Rheum Dis (Nov 29); Epub ahead of print.

200 EFFICACY Signs and symptoms Functioning Spinal inflammation GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the efficacy and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or 100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.

201 QoL Improved patient QoL Night back pain & sleep Summary SIMPONI helps improve patient quality of life AS 27% improvement from baseline in SF-36 PCS with SIMPONI vs 7% with placebo at Week 24 (P<0.001). 1 Patients who switched from placebo to SIMPONI 50 mg at Week 24 demonstrated a quality-of-life bounce back, achieving a 7-fold improvement in SF-36 PCS score by Week 52. 1,2 SF-36 PCS data Improvements in health-related quality of life, as assessed by SF-36 PCS scores, were sustained through 104 weeks. 1,2

202 QoL Improved patient QoL Night back pain & sleep Summary Sustained improvement in SF-36 PCS 1,2 AS Mean change from baseline Week XO P< Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=113 at Week 104) Week 24 Week 52 Week 76 Week 104

203 QoL Improved patient QoL Night back pain & sleep Summary Sustained improvement in SF-36 PCS 1,2 AS Mean change from baseline Week XO P< Sustained improvement at Week SIMPONI patients 2.0 placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24). Numbers are for mean change from baseline in SF-36 PCS Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=113 at Week 104) Week 24 Week 52 Week 76 Week 104

204 QoL Improved patient QoL Night back pain & sleep Summary Sustained improvement in SF-36 PCS 1,2 AS Mean change from baseline Week XO P<0.001 Sustained improvement at Week SIMPONI patients 14.1 placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24). Numbers are for mean change from baseline in SF-36 PCS Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=113 at Week 104) Week 24 Week 52 Week 76 Week 104

205 QoL Improved patient QoL Night back pain & sleep Summary Sustained improvement in SF-36 PCS 1,2 AS Mean change from baseline Week XO Sustained improvement at Week SIMPONI patients P< placebo patients (switched to SIMPONI 50 mg at Week 16 or Week 24). Numbers are for mean change from baseline in SF-36 PCS Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=113 at Week 104) Week 24 Week 52 Week 76 Week 104

206 QoL Improved patient QoL Night back pain & sleep Summary Sustained improvement in SF-36 PCS 1,2 AS Mean change from baseline Week XO P< Sustained improvement at Week SIMPONI patients 15.5 placebo 5 patients (switched to SIMPONI 50 mg at Week 16 or Week 24). Numbers are for mean change from baseline in SF-36 PCS Placebo (switched to SIMPONI 50 mg at Week 16 or Week 24; n=65) SIMPONI 50 mg (n=113 at Week 104) Week 24 Week 52 Week 76 Week 104

207 QoL Improved patient QoL Night back pain & sleep Summary SF-36 = Short Form-36 Health Survey; PCS = physical component score, assessed on a 0 to 50 scale (higher score represents improvement); AS = ankylosing spondylitis; XO = crossover. References 1. Inman RD, et al. Arthritis Rheum. 2008;58(11): Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.

208 EFFICACY Signs and symptoms Functioning Spinal inflammation GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the efficacy and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or 100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.

209 QoL Improved patient QoL Night back pain & sleep Summary SIMPONI helps reduce night back pain and improve sleep 1,2 AS Significant reduction in night back pain with SIMPONI vs placebo at Weeks 14 and 24 (P<0.001). 1,2 Significantly greater reduction in sleep disturbance with SIMPONI vs placebo at Weeks 14 and 24 (P<0.001), as measured by the JSEQ. 1 VAS scores Changes in JSEQ scores significantly correlated with changes in SF-36 summary scores, BASFI scores, night back pain, total back pain, BASDAI scores, and inflammation (morning stiffness). 2

210 QoL Improved patient QoL Night back pain & sleep Summary Improvement in night back pain at Week 24 AS VAS (0 10 cm) Baseline 7.1 Baseline SIMPONI 50 mg monthly (n=138) Placebo (n=78) Baseline Week 14 Week 24

211 QoL Improved patient QoL Night back pain & sleep Summary Improvement in night back pain at Week 24 AS VAS (0 10 cm) Week P<0.001 Week SIMPONI 50 mg monthly (n=138) Placebo (n=78) Baseline Week 14 Week 24

212 QoL Improved patient QoL Night back pain & sleep Summary Improvement in night back pain at Week 24 AS VAS (0 10 cm) Week P<0.001 Week SIMPONI 50 mg monthly (n=138) Placebo (n=78) Baseline Week 14 Week 24

213 QoL Improved patient QoL Night back pain & sleep Summary VAS = visual analogue scale; AS = ankylosing spondylitis; SC = subcutaneous; ASAS = ASsessment in AS international working group criteria; JSEQ = Jenkins Sleep Evaluation Questionnaire; SF-36 = Short Form-36 Health Survey (physical component score assessed on a 0 to 50 scale [higher score represents improvement]); BASFI = Bath AS Functional Index; BASDAI = Bath AS Disease Activity Index. References 1. Inman RD, et al. Arthritis Rheum. 2008;58(11): Deodhar A, et al. Arthritis Care Res. 2010;62(9):

214 QoL Improved patient QoL Night back pain & sleep Summary GO-RAISE: a multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the efficacy and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or 100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.

215 QoL Improved patient QoL Night back pain & sleep Summary Efficacy with monthly SC SIMPONI AS Reduced signs and symptoms 1 Reduced disease activity 1 Sustained improvements 2 4 weeks 14 weeks 44 weeks 1.5 years 2 years

216 QoL Improved patient QoL Night back pain & sleep Summary Efficacy with monthly SC SIMPONI AS Reduced signs and symptoms 1 Almost half of patients achieved an ASAS20 response just 4 weeks after the first injection. Reduced disease activity 1 Sustained improvements 2 4 weeks 14 weeks 44 weeks 1.5 years 2 years

217 QoL Improved patient QoL Night back pain & sleep Summary Efficacy with monthly SC SIMPONI AS Reduced signs and symptoms 1 Almost half of patients achieved an ASAS20 response just 4 weeks after the first injection. Reduced disease activity 1 43% of patients achieved BASDAI50 by Week 14. Sustained improvements 2 4 weeks 14 weeks 44 weeks 1.5 years 2 years

218 QoL Improved patient QoL Night back pain & sleep Summary Efficacy with monthly SC SIMPONI Reduced signs and symptoms 1 Almost half of patients achieved an ASAS20 response just 4 weeks after the first injection. Reduced disease activity 1 43% of patients achieved BASDAI50 by Week 14. Sustained improvements 2 Improvements in signs and symptoms, physical function, and quality of life were maintained through 2 years. 4 weeks 14 weeks 44 weeks 1.5 years 2 years SIMPONI can help to improve quality of life and functionality 4 times greater improvement in SF-36 physical component scores at Week 24 with SIMPONI 50 mg compared with placebo. 1 AS

219 QoL Improved patient QoL Night back pain & sleep Summary ASAS = ASsessment in AS international working group criteria; SC = subcutaneous; BASDAI = Bath AS Disease Activity Index; SF-36 = Short Form-36 Health Survey (physical component score assessed on a 0 to 50 scale [higher score represents improvement]). References 1. Inman RD, et al. Arthritis Rheum. 2008;58(11): Braun J, et al. Ann Rheum Dis. 2011; Epub ahead of print.

220 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested Safety profile of SIMPONI after 3 years 1,2 AS In Phase 3 trials through 3 years 1 : 7.4% of patients receiving injections of SIMPONI 50 mg discontinued therapy because of adverse events vs 4.9% of those receiving placebo injections. SIMPONI has over 8 years of worldwide clinical trial experience and has been used in over 80,000 patients 2,3 Adverse event data

221 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested An analysis of pooled data from the long-term extensions of randomized, double-blind, placebo-controlled studies in AS, RA, and PsA 1 : AS Adverse event 2 (Pooled data) SIMPONI 50 mg +/ MTX Placebo +/ MTX Patients treated (n) 1, Deaths a All serious infections a Tuberculosis (TB) a Opportunistic infections other than TB a Malignancy Nonmelanoma skin cancers Total patient-years of follow-up Incidence/100 patient-years Lymphoma Total patient-years of follow-up Incidence/100 patient-years Other malignancies Total patient-years of follow-up Incidence/100 patient-years 2, , , Includes SIMPONI SC Phase 2b studies in addition to Phase 3 AS, RA, and PsA.

222 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested a Incidence per 100 patient-years. MTX = methotrexate; AS = ankylosing spondylitis; RA = rheumatoid arthritis; PsA = psoriatic arthritis. References 1. Kay J, et al. ACR 2011; abstract Data on file. MSD SIMPONI PSUR Accessed 01/31/12.

223 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested SIMPONI comprehensively tested in worldwide trials AS A comprehensive development program: Phase 3 clinical trials in over 2,300 rheumatology patients 1 6 Trial Indication Patient type Subjects, N GO-BEFORE Active RA MTX naïve 637 GO-FORWARD Active RA MTX nonresponders 444 GO-AFTER Active RA Anti-TNF experienced 461 GO-REVEAL GO-RAISE Active PsA Active AS DMARD nonresponders Conventional therapy nonresponders SIMPONI has been extensively tested in a worldwide clinical trial program in more than 2,300 patients, including different RA a patient groups, as well as those with PsA b or AS c. 1 6

224 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-BEFORE: A multicenter, randomized, double-blind, placebo-controlled study (N=637) in patients with active RA naïve to MTX. Radiographic progression was a primary end point. ACR50 at Week 24 was a primary end point.

225 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-FORWARD: A multicenter, randomized, double-blind, placebo-controlled study (N=444) to examine the effi cacy and safety of SIMPONI in patients with active RA despite MTX therapy. Patients were randomized in a 3:3:2:2 ratio to treatment with placebo injections plus MTX capsules, injections of SIMPONI 100 mg plus placebo capsules, SIMPONI 50 mg plus MTX, or SIMPONI 100 mg plus MTX. Injections were administered subcutaneously every 4 weeks. Primary end points were the proportion of patients with 20% improvement in the ACR criteria at Week 14 and the change from baseline in the HAQ-DI score at Week 24. Responder analysis.

226 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-AFTER: a multicenter, randomized, double-blind, placebo-controlled, Phase III trial (N=461) to evaluate the efficacy and safety of SIMPONI in patients with active rheumatoid arthritis (RA) who had previously received one or more TNFα inhibitors. Patients with active RA were randomly assigned (1:1:1) to placebo or SIMPONI 50 mg or 100 mg. The primary end point was the proportion of patients who achieved 20% or higher improvement in ACR criteria for assessment of RA (ACR20) at Week 14. At Week 16, patients who had less than 20% improvement in tender and swollen joint counts were given rescue therapy in a double-blinded manner: patients in the placebo group received SIMPONI 50 mg, patients in the SIMPONI 50-mg group had a dose escalation to 100 mg, and patients in the SIMPONI 100-mg group continued to receive 100 mg.

227 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-REVEAL: A multicenter, randomized, double-blind, placebo-controlled study (N=405) in patients with active PsA. Patients were randomized to treatment with SC SIMPONI 50 mg, SIMPONI 100 mg, or placebo every 4 weeks to Week 20. The primary end point was the proportion of patients meeting the ACR20 improvement criteria at Week 14.

228 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested GO-RAISE: A multicenter, randomized, double-blind, placebo-controlled study (N=356) to evaluate the efficacy and safety of SIMPONI. Patients with active AS were randomly assigned (1.8:1.8:1) to SC SIMPONI 50 mg or 100 mg, or placebo every 4 weeks. The primary end point was the proportion of patients who achieved ASAS20 response at Week 14. At Week 16, patients who had failed to achieve ASAS20 response entered early escape in a double-blinded manner: patients in the placebo group received SC SIMPONI 50 mg, patients in the group receiving SC SIMPONI 50 mg had a dose escalation to 100 mg, and patients in the 100-mg group continued to receive 100 mg. All other patients in the placebo group were changed over in Week 24 to SC SIMPONI 50 mg.

229 SAFETY 3-year safety data SIMPONI (golimumab) Comprehensively tested a SIMPONI, in combination with MTX, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to DMARD therapy including MTX has been inadequate. the treatment of severe, active, and progressive rheumatoid arthritis in adults not previously treated with MTX. SIMPONI, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function. b SIMPONI, alone or in combination with MTX, is indicated for the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has been shown to reduce the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. c SIMPONI is indicated for the treatment of severe, active AS in adults who have responded inadequately to conventional therapy. RA = rheumatoid arthritis; MTX = methotrexate; TNF = tumor necrosis factor; PsA = psoriatic arthritis; DMARD = disease-modifying antirheumatic drug; AS = ankylosing spondylitis. References 1. SIMPONI.. March Keystone EC, et al. Ann Rheum Dis. 2009;68(6): Erratum in: Ann Rheum Dis. 2011;70(1): Emery P, et al. Arthritis Rheum. 2009;60(8): Erratum in: Arthritis Rheum. 2010;62(10): Smolen JS, et al. Lancet. 2009;374(9685): Inman RD, et al. Arthritis Rheum. 2008;58(11): Kavanaugh A, et al. Arthritis Rheum. 2009;60(4): Erratum in: Arthritis Rheum. 2010;62(8):2555.

230 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Convenience and features that fit with everyday life AS Developed for convenience with only 1 injection per month. 1 5 Features citric acid free formulation a and low injection volume. 1 Low level of ISRs including pain: 5.8% of patients on SIMPONI (50 mg and 100 mg) experienced ISRs vs 2.2% on placebo. 1 Dosing information

231 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Citric acid free formulation a Injection volume AS Monthly SIMPONI autoinjector 50 mg Monthly SIMPONI prefilled syringe 50 mg Adalimumab autoinjector 40 mg and prefilled syringe 40 mg Etanercept autoinjector 50 mg Etanercept prefilled syringe 25 mg

232 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Citric acid free formulation a Injection volume AS Monthly SIMPONI autoinjector 50 mg 0.5 ml Monthly SIMPONI prefilled syringe 50 mg 0.5 ml Adalimumab autoinjector 40 mg and prefilled syringe 40 mg 0.8 ml Etanercept autoinjector 50 mg 1.0 ml Etanercept prefilled syringe 25 mg 0.5 ml

233 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program a A comparison of injection media found that a solution containing citrate as a buffer caused more pain immediately after SC injection than did a solution with histidine as buffer, which did not cause more pain than the control saline solution. 5 ISR = injection site reaction; SC = subcutaneous. References 1. SIMPONI.. March Humira.. January Enbrel.. September Jørgensen JT, et al. Ann Pharmacother. 1996;30(7 8): Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2): Brands mentioned are trademarks of their respective owners.

234 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per month Injections per year

235 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per month Injections per year

236 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per month Injections per year

237 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per month Injections per year

238 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per month Injections per year

239 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per year Injections per month

240 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per year Injections per month

241 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per year Injections per month

242 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per year Injections per month

243 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Only SC anti-tnf with monthly dosing 1 5 AS Injections per year Injections per month

244 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program References 1. SIMPONI.. March Humira.. January Enbrel.. September Jørgensen JT, et al. Ann Pharmacother. 1996;30(7 8): Laursen T, et al. Basic Clin Pharmacol Toxicol. 2006;98(2): Brands mentioned are trademarks of their respective owners.

245 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program State-of-the-art SmartJect autoinjector pen AS Developed to help simplify administration Secure Autoretract needle Security seal Built-in safety sleeve Easy to administer 2 audible clicks Large observation window Easy to handle Easy-grip body Large side button Easy-twist cap In AS, SIMPONI 50 mg is given once a month, on the same date each month. 1 Also available as 0.5-ml, single-use prefilled syringe

246 EXPERIENCE Convenience Monthly dosing State-of-theart devices Patient support program Convenient single-use prefilled syringe AS Developed to help simplify administration Easy to handle Needle guard Thumb-sized plunger head Easy to administer Clear observation window Easy-to-read label Secure Sturdy needle cover Extra-fine needle In AS, SIMPONI 50 mg is given once a month, on the same date each month. 1 Also available as 0.5-ml, single-use, state-of-the-art SmartJect autoinjector pen