(Poster presented on Sunday 05 March, 08:50 08:55; 2017 AAD Meeting, Orlando, Florida, USA)

Transcription

1 Secukinumab in Psoriasis Patients with Concurrent Psoriatic Arthritis: Patient-Reported Outcomes in the Corrona Psoriasis Registry AB Gottlieb, B Strober, 2 AW Armstrong, 3 JD Greenberg, 4,5 C Karki, 4 M Mason, 4 N Guo, 4 I Gilloteau, 6 A Guana, 7 M Lebwohl (Poster presented on Sunday 05 March, 08:50 08:55; 207 AAD Meeting, Orlando, Florida, USA) Department of Dermatology, New York Medical College, Valhalla, NY, USA. 2 University of Connecticut Health Center, Farmington, CT, USA and Probity Medical Research, Waterloo, ON, Canada. 3 University of Southern California, Los Angeles, CA., USA. 4 Corrona, LLC, Southborough, MA, USA. 5 NYU School of Medicine, New York, NY, USA. 6 Novartis Pharma AG, Basel, Switzerland. 7 Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. 8 Icahn School of Medicine at Mount Sinai, New York, NY, USA

2 Disclosures of the Presenting Author Alice Gottlieb, M.D., Ph.D. Amgen Inc. Astellas Akros Centocor (Janssen), Inc. Celgene Corp. Bristol Myers Squibb Co. Beiersdorf, Inc. Abbott Labs. (Abbvie) TEVA Actelion UCB Novo Nordisk Novartis Dermipsor Ltd. Incyte Pfizer Canfite Lilly Coronado Vertex Disclosures Karyopharm CSL Behring Biotherapies for Life Glaxo Smith Kline Xenoport Catabasis Meiji Seika Pharma Co., Ltd Takeda MitsubishiTanabe Pharma Development America, Inc Genentech Baxalta Kineta One KPI Therapeutics Crescendo Bioscience Aclaris Amicus Reddy Labs Research/Educational Grants (paid to Tufts Medical Center) until 5//6 Then None: Centocor (Janssen), Amgen, Abbott (Abbvie), Novartis, Celgene, Pfizer, Lilly, Levia, Merck, Xenoport, Dermira, Baxalta

3 Background Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-7A, has significant efficacy in the treatment of moderate to severe psoriasis and psoriatic arthritis (PsA) with a favorable safety profile -4 The Corrona Psoriasis Registry is an independent observational cohort to compare the safety of FDA-approved systemic treatments in moderate to severe psoriasis in the US Psoriasis can have significant burden on quality of life, and it is estimated that between 30 42% of patients with psoriasis have concurrent PsA 5,6 This presentation describes patient reported outcomes (PROs) in psoriasis patients with concurrent PsA treated with secukinumab and other systemic treatments at registry enrollment. Hueber W et al. Sci Transl Med 200; 2: 52ra72; 2. Papp KA et al. Br J Dermatol 203; 68: 42 42; 3. Rich P et al. Br J Dermatol 203; 68: 402 4; 4. Langley RG et al. N Engl J Med. 204;37: ; 5. Gladman DD et al. Ann Rheum Dis 2005;64 Suppl 2:ii4-7; 6. Zachariae H. Am J Clin Dermatol 2003;4:44 7. IL, interleukin

4 Patients and Methods Corrona: A prospective, multicenter, observational registry for patients with psoriasis Adult patients with psoriasis enrolled between April and May who started/switched to a systemic therapy at enrollment (incident user) or in the previous 2 months (prevalent user), and who had a concurrent PsA diagnosis based on clinical judgement of the treating dermatologist were included in this analysis Patients were stratified by drug groups: biologics (secukinumab, etanercept [ETN], adalimumab [ADA], ustekinumab [UST]), and non-biologics PRO data collected at enrollment into the registry through questionnaires: Work productivity and activity impairment [WPAI; scale 0 00] Health status (EQ-5D-3L, VAS 0 00; 0 = worst, 00 = best) Dermatology-related quality of life (DLQI: 0 question/6 domain 4-point Likert scale, total 30) Fatigue, pain and itch were measured on a VAS scale of 0 00 (0 = none; 00 = very severe) An ANOVA or chi-square test of association was performed for means or proportions, respectively, to indicate if there was an overall difference in the groups (i.e. at least one group was found to differ) Data for 4 patients treated with infliximab and 5 patients treated with ixekizumab are not shown due to small sample sizes. PsA, Psoriatic Arthritis; ETN, etanercept; ADA, adalimumab; UST, ustekinumab; Non-biologics: methotrexate, cyclosporine, apremilast; WPAI, Work Productivity & Activity Impairment Questionnaire; EQ-5D-3L, Self completed measure of health status; DLQI, Dermatology Life Quality Index; VAS, visual analogue scale; ANOVA, Analysis of Variance.

5 Disease Severity and Patient Characteristics of PsA Patients at Enrollment in the Corrona Psoriasis Registry As of May 3 206, 529 psoriasis patients were enrolled in registry. Of those: 69 (40.5%) had a PsA diagnosis (mean disease duration 7.9 years) of which 35% were biologic naïve, 25.0% received secukinumab, 5.7% ETN, 8.7% ADA, 6.8% UST, and 32.3% Non-biologics Parameter Patient disease characteristics at enrollment Secukinumab (N = 55) Etanercept (N = 35) Adalimumab (N = 6) Ustekinumab (N = 04) Nonbiologics (N = 200) All systemics (N = 69) Biologic naïve (n, %) 7% 57% 59% 9% 49% 35% Psoriasis duration, years (mean, ± SD ) 2. (4.) 6. (4.2) 5.3 (3.0) 6.3 (2.6) 4.6 (3.4) 6.8 (3.6) Psoriatic arthritis duration, years (mean, ± SD ) 0. (8.4) 6.4 (0.) 7.2 (8.7) 7.8 (7.5) 6.7 (7.9) 7.9 (8.4) PASI score (0 72), mean (±SD) (9.2) 3.8 (4.0) 5. (7.3) 4.6 (5.6) 4.8 (7.0) 5.5 (7.4)* Incident 0.4 (9.9) 4.9 (3.4) 8.6 (9.3) 7.0 (7.7) 6.7 (9.6) 8.4 (9.3) Prevalent 5.6 (7.9) 3.5 (4.) 3.6 (5.5) 3.9 (4.8) 4. (5.6) 4.2 (5.9) All biologics and non-biologics. 2 Combined score of incident and prevalent users. Incident user: started/switched to a systemic therapy at enrollment; prevalent user: started/switched to a systemic therapy in the previous 2 months *P<0.05 for comparison among groups collectively by ANOVA, showing an overall difference. Data for 4 patients treated with infliximab and 5 patients treated with ixekizumab are not shown due to small sample sizes

6 Effects of Psoriasis on Quality of Life in Patients with Concurrent PsA at Enrollment EQ-5D and DLQI scores were similar across all treatment groups Quality of life scores at enrollment Parameter Secukinumab (N = 55) Etanercept (N = 35) Adalimumab (N = 6) Ustekinumab (N = 04) Non-biologics (N = 200) All systemics (N = 69) Overall health state (EQ-5D) 2 EQ-5D (VAS: 0 00), mean (± SD) 69.6 (2.3) 66.8 (24.6) 7. (22.4) 7.4 (20.7) 66.6 (24.3) 69.0 (22.6) Problems with walking, n (%) 6 (40%) 3 (38%) 37 (32%) 43 (42%) 75 (38%) 232 (38%) Problems with self care, n (%) 20 (3%) (3%) (0%) (%) 25 (3%) 70 (2%) Problems with usual activities, n (%) 74 (49%) 3 (38%) 45 (40%) 32 (32%) 83 (42%) 253 (42%) Pain and discomfort, n (%) 05 (69%) 20 (59%) 72 (62%) 68 (66%) 29 (65%) 40 (65%) Anxiety and depression 50 (33%) (32%) 40 (35%) 3 (30%) 65 (33%) 202 (33%) DLQI 3 (Score 0 30), mean (± SD) 7.6 (6.2) 5.7 (6.0) 6.6 (6.4) 7.8 (7.2) 6. (5.2) 6.8 (6.) DLQI Effect on Life, n (%) 0 : None 27 (8%) 0 (29%) 29 (25%) 22 (2%) 39 (20%) 30 (2%) 2 5: Small 42 (27%) 3 (37%) 38 (33%) 32 (3%) 8 (4%) 209 (34%) 6 0: Moderate 38 (25%) 6 (7%) 20 (7%) 7 (7%) 39 (20%) 2 (20%) 20: Very large 42 (27%) 4 (%) 22 (9%) 24 (23%) 38 (9%) 32 (2%) 2 30: Extremely large 4 (3%) 2 (6%) 7 (6%) 8 (8%) 3 (2%) 24 (4%) All biologics and non-biologics. 2 EQ-5D-3L: Self-completed measure of health status, Scoring: 3 DLQI: Dermatology Life Quality Index, Scoring: VAS 0 00: 0="worst health" 00="best health" status.

7 Mean, ± SD Effect of Psoriasis on Fatigue, Pain and Itch in Patients with Concurrent PsA at Enrollment Mean scores were higher for fatigue, itch, overall pain, joint pain, and Patient Global Assessment in the secukinumab group Fatigue, Pain and Itch VAS scores at enrollment Secukinumab (N = 55) Etanercept (N = 35) Adalimumab (N = 6) Ustekinumab (N = 04) Non-biologics (N = 200) All systemics (N=69) Fatigue Pain Itch Joint pain Patient overall assessment for psoriasis Patient overall assessment for PsA All biologics and non-biologics. VAS 0 00: 0 = none; 00 = very severe. Patient overall assessment (PGA) was also assessed on a VAS scale of 0 00.

8 Mean percentage Effect of Psoriasis on Work Productivity Domains in Patients with Concurrent PsA at Enrollment A similar proportion of patients across all treatment groups was currently employed at enrollment Work impairment and activity impairment was similar across the groups Work productivity (WPAI) 2 at enrollment * Mean % patients currently employed Mean % work hours missed Mean % impairment while working Mean % overall work impairment % activity impairment All biologics and non-biologics. 2 Impairment Questionnaire, Scoring: *P<0.05 for comparison among groups collectively by Chi-square test, showing an overall difference

9 Conclusions: Secukinumab treated psoriasis patients with concurrent PsA have more severe disease characteristics, and for some important PROs the impairment is higher in the secukinumab group compared with other groups Patient reported outcomes were generally similar across the groups. Overall: Approximately three-quarters of patients reported that psoriasis had a negative effect on their life Patients Global Assessment for psoriasis and Global Assessment for PsA were similar across all groups Mean scores were higher for fatigue, itch, overall pain, joint pain, and Patient Global Assessment in the secukinumab group Work and activity impairment was reported by approximately a quarter of patients Future studies will provide long term PRO data for patients with psoriasis and concurrent PsA Corrona Psoriasis Registry is sponsored by Corrona LLC and is funded by Abbvie, Boehringer Ingelheim, Eli Lilly and Company and Novartis Pharmaceutical Corporation. Corrona, LLC has been supported through contracted subscriptions in the last two years by AbbVie, Amgen, Astra Zeneca, BMS, Crescendo, Eli Lilly and Company, Genentech, GSK, Horizon Pharma USA, Janssen, Momenta Pharmaceuticals, Novartis, Pfizer, Roche and UCB. The design and conduct of this research was a collaborative effort between Corrona and Novartis, and financial support for this research was provided by Novartis. Novartis participated in the interpretation of data, review and approval of the abstract. Medical writing support was provided by Tina Patrick, Novartis Ireland Ltd.