Table 4.
Summary of efficacy parameters through week 52 (efficacy full analysis seta)
| 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) |
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
aData imputation was nonresponder imputation for categorical parameters and last observation carried forward for noncategorical parameters