Efficacy outcomes at Week 12 (primary and secondary endpoints).
| Variables | Secukinumab IV Loading, n = 88 | Secukinumab SC Loading, n = 89 | Secukinumab Pooled, n = 177 | Placebo, n = 44 |
|---|---|---|---|---|
| ACR20 responders, n (%) | 47 (53.4) | 40 (44.9) | 87 (49.2) | 18 (40.9) |
| ACR50 responders, n (%) | 18 (20.5) | 16 (18.0) | 34 (19.2) | 5 (11.4) |
| ACR70 responders, n (%) | 7 (8.0) | 5 (5.6) | 12 (6.8) | 0 (0.0) |
| DAS28-CRP | ||||
| LS mean of change (SE) | −1.7 (0.12) | −1.7 (0.12) | −1.7 (0.08) | −1.2 (0.17) |
| LS mean difference (SE) vs placebo | −0.5 (0.20)* | −0.4 (0.21)* | −0.5 (0.19)* | |
| DAS28-ESR | ||||
| LS mean change from baseline (SE) | −2.0 (0.13) | −1.8 (0.13) | −1.9 (0.09) | −1.5 (0.18) |
| LS mean difference (SE) vs placebo | −0.5 (0.22)* | −0.4 (0.22) | −0.4 (0.20)* | |
| Patient’s global assessment of disease activity, VAS, mm | ||||
| LS mean change from baseline (SE) | −18.6 (2.04) | −15.3 (2.06) | −16.9 (1.45) | −9.9 (2.88) |
| LS mean difference (SE) vs placebo | −8.7 (3.53)* | −5.4 (3.55) | −7.0 (3.23)* | |
| Physician’s global assessment of disease activity, VAS, mm | ||||
| LS mean change from baseline (SE) | −27.1 (1.93) | −29.0 (1.95) | −28.0 (1.37) | −18.9 (2.73) |
| LS mean difference (SE) vs placebo | −8.2 (3.34)* | −10.1 (3.36)* | −9.2 (3.05)* | |
| Patient’s assessment of RA pain, VAS, mm | ||||
| LS mean change from baseline (SE) | −14.4 (2.06) | −12.6 (2.07) | −13.5 (1.46) | −6.7 (2.90) |
| LS mean difference (SE) vs placebo | −7.8 (3.56)* | −6.0 (3.57) | −6.9 (3.25)* | |
| hsCRP | ||||
| LS mean change from baseline (SE) | −6.0 (0.94) | −5.7 (0.95) | −5.9 (0.67) | −1.7 (1.34) |
| LS mean difference (SE) vs placebo | −4.3 (1.63)* | −4.0 (1.64)* | −4.2 (1.50)* | |
| HAQ-DI | ||||
| LS mean change from baseline (SE) | −0.4 (0.05) | −0.3 (0.05) | −0.3 (0.04) | −0.2 (0.07) |
| LS mean difference (SE) vs placebo | −0.2 (0.09) | −0.1 (0.09) | −0.1 (0.08) |
↵* p < 0.05 for comparison with placebo. ACR: American College of Rheumatology; CRP: C-reactive protein; DAS28: Disease Activity Score in 28 joints; ESR: erythrocyte sedimentation rate; HAQ-DI: Health Assessment Questionnaire–Disability Index; hsCRP: high-sensitivity C-reactive protein; IV: intravenous; LS: least-square; RA: rheumatoid arthritis; SE: standard error; SC: subcutaneous; VAS: visual analog scale.