Table 2.
Summary results for sarilumab SC 200 mg q2w monotherapy versus other monotherapies in the csDMARD-IR population: median estimates of relative treatment effects (95% credible intervals; base case) for week 24 efficacy and safety (SI, SAE)
| Sarilumab 200 mg vs | ACR20 OR FEM (DIC = 117.98) | ACR50 OR FEM (DIC = 112.39) | ACR70 OR FEM (DIC = 99.93) | DAS28 rem RD FEM (DIC = – 6.69) |
|---|---|---|---|---|
| Placebo | 9.69 (5.19 to 18.28) | 11.88 (5.81 to 25.28) | 18.99 (5.78 to 77.53) | – |
| csDMARD | 9.1 (3.88 to 21.86) | 5.41 (2.16 to 13.79) | 4.98 (1.52 to 17.2) | 0.313 (0.142 to 0.486) |
| Adalimumab | 1.82 (1.18 to 2.83) | 1.99 (1.3 to 3.07) | 2.28 (1.31 to 4.06) | 0.196 (0.123 to 0.269) |
| Certolizumab | 1.11 (0.4 to 2.9) | 1.43 (0.33 to 5.15) | 0.67 (0 to 13.77) | – |
| Etanercept | 1.01 (0.43 to 2.39) | 0.94 (0.33 to 2.54) | 0.47 (0.05 to 2.61) | – |
| Tocilizumab 8 | 0.89 (0.48 to 1.65) | 0.84 (0.45 to 1.57) | 1.06 (0.5 to 2.29) | − 0.098 (− 0.213 to 0.018) |
| Tofacitinib | 3.11 (1.09 to 8.64) | 2.42 (0.64 to 8.43) | 5.1 (0.82 to 32.01) | – |
| Sarilumab 200 mg vs | HAQ-DI CFB diff FEM (DIC = − 21.08) | EULAR good RD FEM (DIC = − 9.04) | EULAR mod–good RD FEM (DIC = − 7.90) | SI RD FEM (DIC = − 15.76) | SAE RD FEM (DIC = − 11.28) |
|---|---|---|---|---|---|
| Placebo | − 0.488 (− 0.666 to − 0.309) | 0.32 (0.206 to 0.434) | 0.428 (0.279 to 0.576) | 0.055 (− 0.006 to 0.114) | 0.078 (− 0.033 to 0.189) |
| csDMARD | − 0.199 (− 0.563 to 0.166) | 0.575 (0.389 to 0.761) | 0.482 (0.299 to 0.664) | – | – |
| Adalimumab | − 0.181 (− 0.319 to − 0.041) | 0.268 (0.173 to 0.363) | 0.135 (0.05 to 0.219) | 0 (− 0.021 to 0.021) | − 0.016 (− 0.064 to 0.031) |
| Certolizumab | 0.002 (− 0.328 to 0.331) | – | – | 0.037 (− 0.031 to 0.103) | 0.034 (− 0.091 to 0.159) |
| Etanercept | 0.113 (− 0.22 to 0.445) | – | – | – | – |
| Tocilizumab 8 | 0.026 (− 0.236 to 0.289) | − 0.05 (− 0.187 to 0.087) | − 0.095 (− 0.226 to 0.035) | – | – |
| Tofacitinib | – | – | – | 0.084 (− 0.01 to 0.178) | 0.137 (− 0.006 to 0.28) |
Bold text indicates in favor of sarilumab 200 mg monotherapy; black text indicates that the two treatment options are comparable
ACR20/50/70 American College of Rheumatology 20/50/70% response criteria, csDMARD conventional synthetic disease-modifying antirheumatic drug, CFB change from baseline, DAS28 European League Against Rheumatism Disease Activity Score 28-joint count (DAS28) remission (defined as DAS28 erythrocyte sedimentation rate or C-reactive protein < 2.6), DIC device information criterion, diff difference, FEM fixed-effect model, EULAR European League Against Rheumatism, HAQ-DI Health Assessment Questionnaire Disability Index, IR inadequate responders or intolerant; mod, moderate, OR odds ratio, q2w every 2 weeks, RD risk difference, rem remission, SAE serious adverse event, SC subcutaneous, SI serious infection