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Table 4 Summary of efficacy parameters through week 52 (efficacy full analysis seta)

From: Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients

Efficacy parameter Sirukumab 50 mg q4w (N = 61) Sirukumab 100 mg q2w (N = 61)
ACR20 response, n (%)
 Week 16 47 (77.0) 44 (72.1)
 Week 24 45 (73.8) 50 (82.0)
 Week 52 39 (63.9) 46 (75.4)
ACR50 response, n (%)
 Week 16 29 (47.5) 35 (57.4)
 Week 24 30 (49.2) 39 (63.9)
 Week 52 29 (47.5) 35 (57.4)
ACR70 response, n (%)
 Week 16 16 (26.2) 20 (32.8)
 Week 24 15 (24.6) 22 (36.1)
 Week 52 20 (32.8) 24 (39.3)
HAQ-DI
 Week 16 median decrease from baseline, % 41.2 51.5
 Week 52 median decrease from baseline, % 44.5 70.0
CRP levels (mg/dl), mean (SD)
 Week 16 0.02 (0.05) 0.02 (0.02)
 Week 52 0.02 (0.06) 0.02 (0.02)
DAS28-CRP response
 Week 16 responders, n (%) 55 (90.2) 59 (96.7)
 Week 52 responders, n (%) 45 (73.8) 50 (82.0)
DAS28-CRP remission
 Week 16 remitters, n (%) 28 (45.9) 30 (49.2)
 Week 52 remitters, n (%) 29 (47.5) 32 (52.5)
SDAI
 Week 16 change from baseline, mean (SD) −22.4 (12.44) −25.9 (13.99)
 Week 52 change from baseline, mean (SD) −23.3 (14.02) −28.5 (15.94)
CDAI
 Week 16 change from baseline, mean (SD) −19.4 (12.14) −22.7 (13.23)
 Week 52 change from baseline, mean (SD) −20.4 (13.83) −25.3 (15.26)
HAQ-DI response
 Week 16 responders, n (%) 46 (75.4) 41 (67.2)
 Week 52 responders, n (%) 44 (72.1) 41 (67.2)
  1. ACR20/50/70 American College of Rheumatology 20/50/70 response, CDAI Clinical Disease Activity Index, CRP C-reactive protein, DAS28 Disease Activity Score 28, HAQ-DI Health Assessment Questionnaire-Disability Index, SD standard deviation, SDAI Simplified Disease Activity Index, q4w once in 4 weeks, q2w once in 2 weeks
  2. aData imputation was nonresponder imputation for categorical parameters and last observation carried forward for noncategorical parameters