Vectra DA: A Better Measure for Predicting Radiographic Progression in Rheumatoid Arthritis?

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1 Vectra DA: A Better Measure for Predicting Radiographic Progression in Rheumatoid Arthritis? Ronald F. van Vollenhoven, MD, PhD Jonathan Kay, MD Andrew Laster MD, FACR Eric Sasso, MD Crescendo Bioscience is the sponsor of the presentation. 1

2 Agenda Introduction: - Eric Sasso, MD, Crescendo Bioscience The Role of CRP and ESR in Assessing RA Disease Activity: - Jonathan Kay, MD, UMass Medical School Vectra DA and Radiographic Progression: - Eric Sasso, MD, Crescendo Bioscience - Ronald van Vollenhoven, MD, PhD, Karolinska Institute Clinical Applications of Vectra DA: - Andrew Laster, MD, FACR, Arthritis & Osteoporosis Consultants of the Carolinas Q&A 2

3 Vectra DA Intended Use Vectra DA, a multi-biomarker blood test, was validated to measure disease activity in adults diagnosed with rheumatoid arthritis Test results are intended to Aid in the assessment of disease activity in RA patients Help inform patient management decisions when used in conjunction with standard clinical assessment This test is not intended or validated to: Diagnose RA Guide therapy selection Interpretation of individual biomarker results has not been validated 3

4 Vectra DA Biomarkers: Twelve biomarkers reflect the heterogeneity of RA Biomarker Biomarker Category VCAM-1 EGF VEGF-A IL-6 TNF-RI MMP-1 MMP-3 Adhesion Molecules Growth Factors Cytokine-related Proteins Matrix Metalloproteinases Primary Role Cellular influx and tissue expansion Local inflammation and destruction Cartilage degradation and joint damage YKL-40 Skeletal-related Proteins Stromal activity & regulation (fibroblasts, chondrocytes, vascular cells) Leptin Resistin SAA CRP Hormones Acute Phase Proteins Systemic Inflammatory Response 4

5 An algorithm is applied to the concentrations of individual biomarkers to calculate a Vectra DA score from 1 to 100 * The range reflects the precision of the score based on repeat measurements. 5

6 The Role of CRP and ESR in Assessing RA Disease Activity Jonathan Kay, MD UMass Medical School Crescendo Bioscience is the sponsor of the presentation. 6

7 Disclosures Research Support: AbbVie Inc.; Ardea Biosciences, Inc.; Eli Lilly and Company; Fidia Farmaceutici, SpA; Roche Laboratories, Inc. Consultant: AbbVie Inc.; Amgen, Inc.; AstraZeneca; Bristol-Myers Squibb Company; Celgene Corp.; Crescendo Bioscience, Inc.; Eli Lilly and Company; EPIRUS Biopharmaceuticals, Inc.; Genentech Inc.; Hospira, Inc.; Janssen Biotech, Inc.; medac pharma Inc.; PanGenetics, B.V.; Pfizer Inc.; Roche Laboratories, Inc.; Sun Pharmaceutical Industries Ltd.; UCB, Inc. 7

8 8

9 Background Patients with active RA often have elevated tender & swollen joint counts and patient & MD global assessment, yet have normal ESR and/or CRP These discordances imply that when ESR and CRP are in the normal range, they may be uninformative in clinical practice, especially for patients with active RA These discordances also imply that patients may fail to meet clinical trial APR entry criteria despite having active disease. 1 1 Sokka T, Pincus T. Arthritis Rheum. 2003; 48:

10 Study Overview Observational study CORRONA database October 1, 2001 through February 27, RA patients with active disease All had CDAI >2.8 at a visit ESR and CRP obtained at visit 4,031 (44.1%) were biologic-naïve Kay J, Morgacheva O, Messing S, et al. Arthritis Research & Therapy 2014; 16(1) 10

11 Baseline Characteristics by APR Levels Neither APR elevated n=2520 APR levels discordant n=1058 Both APR elevated n=650 P-Value Age (years) 59.29± ± ± < Duration of RA (years) 11.01± ± ± CDAI ± ± ± < Tender Joints 3.73 ± ± ± 7.21 <0.0001* Swollen Joints 4.04 ± ± ± 6.42 <0.0001* Patient Global Assessment ± ± ± < MD Global Assessment ± ± ± < Prednisone Use 680 (26.98%) 341 (32.23%) 275 (42.31%) < Methotrexate Use 1668 (66.19%) 698 (65.97%) 417 (64.15%) Biologic Use 1263 (50.12%) 447 (42.25%) 224 (34.46%) < * Log-linear model (Poisson) - χ² test Kay J, Morgacheva O, Messing S, et al. Arthritis Research & Therapy 2014; 16(1) 11

8* n = 6,507 30% ESR >28* n = 2,719 70% ESR 28* n = 6,416 * Units of CRP are mg/dl;

12 ESR and CRP were each low in ~70% of patients Data from 9,135 patients with active RA (CDAI >2.8) from the CORRONA registry 29% CRP >0.8* n = 2,628 71% CRP 0.8* n = 6,507 30% ESR >28* n = 2,719 70% ESR 28* n = 6,416 * Units of CRP are mg/dl; Units of ESR are mm/hr Kay J, Morgacheva O, Messing S, et al. Arthritis Research & Therapy 2014; 16(1) 12

CRP and ESR were both low in 58% of patients with active RA Data from 9,135 patients with active RA (CDAI >2.8) from the CORRONA registry 42% ESR >28* and/or CRP >0.

13 CRP and ESR were both low in 58% of patients with active RA Data from 9,135 patients with active RA (CDAI >2.8) from the CORRONA registry 42% ESR >28* and/or CRP >0.8* n = 3,840 58% ESR 28* and CRP 0.8* n = 5,295 * Units of CRP are mg/dl; Units of ESR are mm/hr Kay J, Morgacheva O, Messing S, et al. Arthritis Research & Therapy 2014; 16(1) 13

14 Similar levels of low CRP and ESR were seen among the 4,031 biologic-naïve patients with active RA (CDAI >2.8) 34% CRP >0.8* n = 1,357 66% CRP 0.8* n = 2,674 32% ESR >28* n = 1,275 68% ESR 28* n = 2,756 * Units of CRP are mg/dl; Units of ESR are mm/hr Kay J, Morgacheva O, Messing S, et al. Arthritis Research & Therapy 2014; 16(1) 14

15 Similar levels of low CRP and ESR were seen among the 4,031 biologic-naïve patients with active RA (CDAI >2.8) 46% ESR >28* and/or CRP >0.8* n = 1,867 54% CRP 0.8* and ESR 28* n = 2,164 * Units of CRP are mg/dl; Units of ESR are mm/hr Kay J, Morgacheva O, Messing S, et al. Arthritis Research & Therapy 2014; 16(1) 15

In both moderate and high CDAI Disease Activity Levels, both ESR and CRP were low in ~50% of patients 100% 90% 80% 70% 60% 10% 23% 16% 27% 26% 28% Both CRP and ESR elevated 50% 40% 30% 20% 67% 57%

16 In both moderate and high CDAI Disease Activity Levels, both ESR and CRP were low in ~50% of patients 100% 90% 80% 70% 60% 10% 23% 16% 27% 26% 28% Both CRP and ESR elevated 50% 40% 30% 20% 67% 57% 46% Either CRP or ESR elevated Neither CRP or ESR elevated 10% 0% CDAI LDA MDA HDA CDAI LDA CDAI MDA CDAI HAD (>2.8 & 10) (>10 & 22) (>22) LDA = Low Disease Activity, MDA = Moderate Disease Activity, HDA = High Disease Activity Kay J, Morgacheva O, Messing S, et al. Arthritis Research & Therapy 2014; 16(1) 16

17 Summary Patients with active RA often have elevated tender & swollen joint counts and patient & MD global assessment, yet have normal ESR and/or CRP These discordances imply that when ESR and CRP are in the normal range, they may be uninformative in clinical practice, especially for patients with active RA These discordances also imply that patients may fail to meet clinical trial APR entry criteria despite having active disease. 1 1 Sokka T, Pincus T. Arthritis Rheum. 2003; 48:

Percentage of Assessments Multiple Cohorts ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Vectra DA algorithm scores were frequently moderate or high when CRP was low ( 1 mg/dl) 100%

18 Percentage of Assessments Multiple Cohorts ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Vectra DA algorithm scores were frequently moderate or high when CRP was low ( 1 mg/dl) 100% 90% 13% 13% 80% 70% 60% 50% 40% 30% 20% 10% 0% 59% 34% 7% SWEFOT SWEFOT era era Pre-MTX Pre-MTX N = 71/ % 54% 33% Leiden Leiden Stable Stable DMARDs DMARDs N = 158/ % 36% 51% BRASS Stable Therapy Stable BRASS Therapy N = 184/ % Vectra DA algorithm score High (>44) Mod (30-44) Low (<30) Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases doi: /annrheumdis ; Lee, YC. et al, ACR 2013, Arthritis Rheum 2013;65 Suppl 10:2683; Li W, et al, EULAR 2013, poster # FRI0098; Data on File * The Vectra DA algorithm and biomarkers were used in a study performed in Crescendo s R&D lab 18

19 Percentage of Assessments SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Vectra DA algorithm scores were also frequently moderate or high when ESR was low ( 25) 100% Low CRP Low ESR 90% 80% 70% 60% 50% 40% 30% 20% 59% 34% 68% 26% Vectra DA algorithm score High (>44) Mod (30-44) Low (<30) 10% 0% 7% 7% SWEFOT SWEFOT era era Pre-MTX SWEFOT Leiden Stable era DMARDs Pre-MTX BRASS Stable Therapy N = 71/ % N = 74/ % Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases doi: /annrheumdis ; ; Crescendo Data on File SWEFOT: CRP groups are based on CRP values from clinical laboratory 19

20 Vectra DA and Radiographic Progression Eric Sasso, MD Crescendo Bioscience Ronald F. van Vollenhoven, MD, PhD Karolinska Institute Crescendo Bioscience is the sponsor of the presentation. 20

21 Disclosures Dr. Eric Sasso is an employee of Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. 21

22 Leiden Stable DMARDs Crescendo Bioscience is the sponsor of the presentation. 22

Stable DMARDS / Leiden ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Leiden study N=271 visits for 163 patients Clinic visit On

23 Stable DMARDS / Leiden ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Leiden study N=271 visits for 163 patients Clinic visit On DMARDs 1 year Clinical data Vectra DA X-ray #1 X-ray #2 Radiographic progression van der Helm-van Mil, et al. Rheumatology (5):

Δ SHS > 3 in a 12 month period Stable DMARDS / Leiden ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Vectra DA algorithm score discriminated risk for radiographic

8 N = 271 visits, 163 patients 50% 40% 43% 37% 30% 20% 15% 18% 20% 27% 24% 10% 7% 0% n = 3/43 Vectra DA 2/13 Algorithm 19/105 Score 47/110 n = 17/83 8/30 DAS28CRP 23/95 23/63 Range = 25

24 Δ SHS > 3 in a 12 month period Stable DMARDS / Leiden ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Vectra DA algorithm score discriminated risk for radiographic progression better than DAS28-CRP Vectra DA Algorithm Score DAS28-CRP RR = 6.1 P<0.05 RR = 1.8 N = 271 visits, 163 patients 50% 40% 43% 37% 30% 20% 15% 18% 20% 27% 24% 10% 7% 0% n = 3/43 Vectra DA 2/13 Algorithm 19/105 Score 47/110 n = 17/83 8/30 DAS28CRP 23/95 23/63 Range = 25 (Remission ; High >44) <2.3 (Remission 2.3 <2.32; to >2.7 High to >4.1) Remission Low Moderate High van der Helm-van Mil, et al. Rheumatology doi: /rheumatology/kes378 The Vectra DA algorithm and biomarkers were used in a study performed in Crescendo s R&D lab 24

25 Stable DMARDS / Leiden Good radiographic outcome (ΔSHS 3) for patients in remission versus non-remission Definition of Remission Remission Nonremission P-value PLR DAS28-CRP < % (66/83) 71% (134/188) ACR/EULA R 83 (25/30) 73 (175/241) Vectra DA (40/43) 70 (160/228) van der Helm-van Mil, et al. Rheumatology (5):

26 Stable DMARDS / Leiden Good radiographic outcome (ΔSHS 3) for patients in remission versus non-remission Definition of Remission Remission Nonremission P-value PLR DAS28-CRP < % (66/83) 71% (134/188) ACR/ EULAR 83% (25/30) 73% (175/241) Vectra DA (40/43) 70 (160/228) van der Helm-van Mil, et al. Rheumatology (5):

27 Stable DMARDS / Leiden Good radiographic outcome (ΔSHS 3) for patients in remission versus non-remission Definition of Remission Remission Nonremission P-value PLR DAS28-CRP < % (66/83) 71% (134/188) ACR/ EULAR 83% (25/30) 73% (175/241) Vectra DA 25 93% (40/43) 70% (160/228) van der Helm-van Mil, et al. Rheumatology (5):

28 Stable DMARDS / Leiden Good radiographic outcome (ΔSHS 3) for patients in remission versus non-remission Definition of Remission Remission Nonremission P-value PLR DAS28-CRP < % (66/83) 71% (134/188) ACR/ EULAR 83% (25/30) 73% (175/241) Vectra DA 25 93% (40/43) 70% (160/228) van der Helm-van Mil, et al. Rheumatology (5):

29 Vectra DA and Radiographic Progression Ronald F. van Vollenhoven, MD, PhD Karolinska Institute Crescendo Bioscience is the sponsor of the presentation. 29

30 Disclosures Research support, consultancy: AbbVie, Biotest, BMS, Crescendo, GSK, Janssen, Lilly, Merck, Pfizer, Roche, UCB, Vertex 30

31 31

32 era / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted SWEFOT Vectra DA Analysis Overview Patients from 15 rheumatology units in Sweden Early rheumatoid arthritis (era) patients with disease duration <1 year, DMARD nai ve X-ray #1 Clinical Data Vectra DA (N = 235) Assess Response ΔSHS X-ray #2 BL month 3 year 1 Start MTX R NR MTX MTX/H/S MTX/Inf R = Responders NR = Non Responders MTX/H/S = Methotrexate with sulfasalazine and hydroxychloroquine MTX/Inf = Methotrexate with infliximab Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases doi: /annrheumdis ; 32

33 % Rapid Radiographic Progressors (Δ SHS >5 BL to year 1) era / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Vectra DA categories predicted risk of rapid radiographic progression (ΔSHS >5) over 1 year 35% 30% 25% 20% 21% 15% 10% 5% 0% n = 3% 0% 0/5 1/29 42/201 Low Moderate High (<30) (30-44) (>44) Vectra DA Score at Baseline (Total N = 235) Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases doi: /annrheumdis ; 33

34 % Rapid Radiographic Progressors (Δ SHS >5 BL to year 1) era / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Vectra DA categories predicted risk of rapid radiographic progression (ΔSHS >5) over 1 year 35% 30% 25% 20% 15% p = x Relative Risk 21% 10% 5% 0% n = 3% 0% 0/5 1/29 42/201 Low Moderate High (<30) (30-44) (>44) Vectra DA Score at Baseline (Total N = 235) Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases doi: /annrheumdis ; Data on File The p value represents low/moderate vs. high Vectra DA score. The p value for moderate vs. high Vectra DA score is (figure 2D) 34

35 Δ Total Sharp-van der Heijde Score era / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Baseline Vectra DA score categories differentiated radiographic progressors at 1 year BL Vectra DA Levels High (> 44), n = 201 Moderate (30 44), n = 29 Low (< 30), n = 5 ΔSHS>5 21% 3% 0% 5 ΔSHS>5 Cumulative % of Patients N=235 Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases doi: /annrheumdis ; 35

36 Δ Total SHS Δ Total SHS era / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Baseline Vectra DA score differentiated radiographic progressors at year 1 better than baseline CRP, ESR, or DAS28-ESR Δ Total SHS Δ Total SHS Vectra DA category High (> 44), n = 201 Cumulative % of Patients DAS28-ESR category High (>5.1), n = 167 Moderate (> ), n = 68 Low High ( (>5.1), 3.2), n = 0167 ΔSHS>5 Moderate High (> 44), (30 n = 44), 201 n = 29 21% Low Moderate (< 30), (30 n = 544), n = 29 3% Low (< 30), n = 5 0% 5 5 ΔSHS>5 20% Moderate (> ), n = 68 15% Low ( 3.2), n = 0 CRP category High (> 3 mg/dl), n = 89 Moderate (> 1-3 mg/dl), n = 75 High (> 3 mg/dl), n = 89 Low ( 1 mg/dl), 71 Moderate (> 1-3 mg/dl), n = 75 Cumulative % of Patients 3 rd Tertile (>44 mm/h), n = 80 2 nd Tertile (>25-45 mm/h), n = 81 3 rd 1 st Tertile (>44 ( 25 mm/h), mm/h), n = n 80 = 74 ESR category ΔSHS>5 25% 15% Low ( 1 mg/dl), n = 71 14% 2 nd Tertile (>25-45 mm/h), n = 81 1 st Tertile ( 25 mm/h), n = 74 ΔSHS>5 26% 15% 14% 5 5 Cumulative % of Patients N=235 Cumulative % of Patients SHS = Sharp-van der Heijde Score Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases doi: /annrheumdis ; 36

37 Number of Patients era Pre-MTX / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Rapid radiographic progression at 1 year in patients with high Vectra DA (>44) was observed across CRP categories at baseline Baseline Vectra DA Score Baseline Vectra DA Low (<30) Mod ΔSHS (30 >5 (n 44) = 43) High (>44) ΔSHS >5 at 1 year Low ( 1) Mod (>1 3) High (>3) n = 71 n = 75 n = 89 Baseline CRP (mg/dl) Hambardzumyan K, Bolce R, Saevarsdottir S, et al. Annals of the Rheumatic Diseases doi: /annrheumdis ; 37

Rapid Radiographic Progressors (Δ SHS > 5) from Year 1 to 2 era / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Persistence of a high Vectra DA score at Year 1 was associated

38 Rapid Radiographic Progressors (Δ SHS > 5) from Year 1 to 2 era / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Persistence of a high Vectra DA score at Year 1 was associated with rapid progression from Year 1 to Year 2 (ΔSHS >5) Among Patients with High Vectra DA at Baseline 40% 35% 30% 20% 10% 4% 6% n = 0% N= 51 DAS28CRP (Remission <2.32; High >4.1) Low Moderate High Vectra DA Score at Year 1 Patients had high Vectra DA score at BL and were MTX non-responders at Month 3. Rapid radiographic progression is defined as ΔSHS >5 in one year. Hambardzumyan, K. Ann Rheum Dis 2014;73(Suppl2). 38

39 Vectra DA is not validated to guide therapy selection. The statements/conclusions provided herein are based on a secondary analysis of the SWEFOT trial data. Additional validation studies would be required to support use of Vectra DA as a predictor of therapy response. 39

40 Patients with DAS at year 1 era / SWEFOT ML-ACR2014ITSlides-01 11/14 unauthorized changes not permitted Response to triple therapy was best following a large decrease in Vectra DA score (>20) on MTX monotherapy 80% Triple therapy Anti-TNF 70% 67% 60% 57% 50% 40% 43% 37% 30% 20% 10% 0% n = 12/18 19/44 6/16 29/51 Δ >20 Δ 20 Δ >20 Δ 20 Δ Vectra DA at month 3 of MTX Vectra DA is not validated to guide therapy selection. The statements/conclusions provided herein are based on a secondary analysis of the SWEFOT trial data. Additional validation studies would be required to support use of Vectra DA as a predictor of therapy response. Hambardzumyan, K. Ann Rheum Dis 2014;73(Suppl2). 40

41 Clinical Applications of Vectra DA Andrew Laster MD, FACR Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC Crescendo Bioscience is the sponsor of the presentation. 41

42 Disclosures Advisory board: Amgen, Crescendo Bioscience, Genentech/ Roche, Lilly, UCB Speakers Bureau: Abbvie, Amgen, Crescendo Bioscience, Genentech/ Roche, GSK, Lilly, UCB Consultant: Augmedix, Hologic, Medimaps 42

43 Arthritis & Osteoporosis Consultants of the Carolinas Community based independent rheumatology practice in Charlotte, NC (pop.1.5 x 10 6 ) 6 rheumatologists / 2 NPs / 41 total staff Single office Full capability with X ray and U/S MRI not available in office without CON in NC 43

44 Use of Vectra DA in My Practice Number of RA patients in practice: 456 Tested with Vectra DA in Last 12 Months: 322 (71%) Single test 52% > 1 test 48% Score Distribution for Last 12 Months Score Composite for Last 12 Months 30% 25% 20% 15% 10% 5% 0%

45 Why Not Just Rely on the Clinical Exam? 12-30% of patients with apparent clinical remission have evidence of radiographic progression 1,2,3 Advanced imaging with U/S or MRI: has superior sensitivity compared to clinical evaluation for detecting synovitis correlates with subsequent X ray damage and functional outcome ~ 60% of patients not in clinical remission do not progress radiographically 2 1 Brown et al Arthritis Rheum 2008; 58(10): Lillegraven et al Ann Rheum Dis 2012; 71(50): van der Helm-van Mil et al Rheumatology 2013; 52 (5):

46 Vectra DA: How I incorporate into practice Clinical Exam Role of Vectra Comments Normal joint exam Synovitis on exam and no radiographic abnormalities (erosions/jsn) Synovitis on exam + erosions and/or JSN Tender joints without obvious synovitis Rule out subclinical synovitis Assess likelihood of radiographic progression Helps assess adequacy of response to therapy Helps assess patients with co-morbidities (Fibromyalgia / OA) If ESR/CRP are normal, an elevated Vectra DA score may lead to U/S or MRI to confirm active RA Low Vectra DA score means lower risk of progression. High Vectra DA score means higher risk of progression. Clinical measures and ESR/CRP may not be sufficient in assessing LDA or remission. Low Vectra DA means active RA is less likely 46

47 Other Possible Roles for Vectra DA Monitor response to drug therapy: MTX +/- corticosteroids Biologic therapy: abatacept, adalimumab, etanercept, golimumab, infliximab, tocilizumab* tofacitinib Insurance approval: Biologic dosing: adalimumab, tofacitinib Assessment of disease activity in single joint instead of MRI * Change in Vectra DA score during tocilizumab treatment may underestimate the change in clinical response 47

48 Summary: Clinical Utility of Vectra DA in My Practice Vectra DA has had a significant impact on my ability to better assess disease activity in RA patients with a variety of presentations (there is not one ideal patient type where Vectra DA is best suited): Identify patients with sub-clinical synovitis Exclude active RA in setting of co-morbidities Assess early in disease course, likelihood of progression with radiographic damage Vectra DA has resulted in more selective utilization of advanced diagnostic imaging in my practice Vectra DA has allowed me to more confidently manage drug therapy in a treat-to-target approach 49

49 Q&A Crescendo Bioscience is the sponsor of the presentation. 50

50 Vectra DA Posters and Presentations at ACR Oral Presentations Wednesday, Nov. 19; Room 258B 9:30 9:45 AM 2973 The Multi-Biomarker Disease Activity Score as a Predictor of Radiographic Progression in a Registry of Patients with Rheumatoid Arthritis; E.H. Sasso, G. Wu, C.C. Hwang, M.E. Weinblatt, N.A. Shadick,C. Alexander, O.G. Segurado 9:45 10:00 AM 2974 Multi-Biomarker Disease Activity Score is Associated with Power Doppler Ultrasound in Patients with Rheumatoid Arthritis in Low Disease Activity State; M.H. Ma, T. Garrood, W. Li, N.A. Defranoux, G.H. Kingsley, A.P. Cope, D. Scott Poster Presentations Sunday, Nov 16, 9:00 11:00 AM; Exhibit Hall B 364 In Early Rheumatoid Arthritis, the Multi-Biomarker Disease Activity Score at Different Time-Points is Predictive of Subsequent Radiographic Progression; K. Hambardzumyan R.J. Bolce, S. Saevarsdottir, K. Forslind, I.F. Petersson, P. Geborek, E.H. Sasso, D. Chernoff, S. Cruickshank, R.F. van Vollenhoven 367 In Early Rheumatoid Arthritis Patients with Non-Response to Methotrexate Monotherapy the Change in Multi- Biomarker Disease Activity Score is Differentially Associated with Subsequent Response to Non-Biological Versus Biological Therapy; K. Hambardzumyan, R.J. Bolce, S. Saevarsdottir, K. Forslind, I.F. Petersson, P. Geborek, E.H. Sasso, D. Chernoff, S. Cruickshank, R.F. van Vollenhoven 376 Using the Multi-Biomarker Disease Activity Score as a Complementary Inclusion Criterion for Clinical Trials in Rheumatoid Arthritis May Enhance Recruitment; R.F. van Vollenhoven, R. Bolce, K. Hambardzumyan, S. Saevarsdottir, K. Forslind, I.F. Petersson, E.H. Sasso, C.C Hwang, O.G. Segurado, P. Geborek Tuesday, Nov. 18; 9:00 11:00 AM Exhibit Hall B 2615 Preliminary Assessment of a Multi-Biomarker Disease Activity Test for Axial Spondyloarthritis; W.P. Maksymowych, S. Wichuk, P.S. Eastman, E.H. Sasso 51

Vectra DA for the objective measurement of disease activity in patients with rheumatoid arthritis

Vectra DA for the objective measurement of disease activity in patients with rheumatoid arthritis O.G. Segurado, E.H. Sasso Crescendo Bioscience, South San Francisco, United States. Oscar G. Segurado,