Table 4.
Summary results for sarilumab 200 mg q2w combinations vs other combinations in the TNFi-IR population: median estimates of relative treatment effects (95% credible intervals) (base case) for week 24 efficacy and safety (SI, SAE)
| Sarilumab 200 mg+csDMARD combination vs: | ACR20 RD FEM (DIC=–25.55) |
ACR50 RD FEM (DIC=–35.76) |
ACR70 RD FEM (DIC=–36.14) |
DAS28<2.6 RD FEM (DIC=–36.30) |
HAQ CFB diff FEM (DIC=–55.78) |
SI 24 week OR FEM (DIC=78.37) |
SAE 24 week OR FEM (DIC=128.27) |
| csDMARDs+placebo |
0.272
(0.173 to 0.371) |
0.225
(0.135 to 0.316) |
0.091
(0.026 to 0.157) |
0.216
(0.141 to 0.292) |
−
0.241
( − 0.376 to − 0.102 ) |
0.97 (0.1 to 9.4) |
1.72 (0.61 to 5.23) |
| csDMARDs+: | |||||||
| Abatacept | −0.036 (−0.17 to 0.098) |
0.06 (−0.048 to 0.168) |
0.005 (−0.073 to 0.082) |
0.122
(0.037 to 0.208) |
0.081 (−0.083 to 0.245) |
0.88 (0.06 to 12.83) |
1.85 (0.54 to 6.77) |
| Baricitinib 2 mg combi | 0.096 (−0.043 to 0.236) |
0.126
(0.006 to 0.248) |
−0.007 (−0.093 to 0.08) |
0.169
(0.074 to 0.265) |
−0.01 (−0.217 to 0.198) |
1.24 (0.09 to 18.36) |
3.38 (0.83 to 14.96) |
| Baricitinib 4 mg combi | 0.081 (−0.058 to 0.221) |
0.063 (−0.061 to 0.186) |
−0.044 (−0.133 to 0.046) |
0.058 (−0.045 to 0.161) | 0.04 (−0.167 to 0.248) |
0.8 (0.06 to 10.76) |
1.2 (0.33 to 4.56) |
| Golimumab combi | 0.1 (−0.038 to 0.237) |
0.094 (−0.021 to 0.209) |
0.006 (−0.081 to 0.094) |
0.138
(0.044 to 0.231) |
−0.03 (−0.206 to 0.146) |
0.96 (0.07 to 13.14) |
2.4 (0.64 to 9.48) |
| Tocilizumab 4 mg/kg intravenous combi | 0.069 (−0.062 to 0.199) |
0.096 (−0.016 to 0.207) |
0.054 (−0.021 to 0.13) |
0.161
(0.072 to 0.249) |
0.02 (−0.165 to 0.206) |
1.8 (0.12 to 28.59) |
2.78 (0.77 to 10.83) |
| Tocilizumab 8 mg/kg intravenous combi | −0.127 (−0.26 to 0.006) |
−0.025 (−0.142 to 0.092) |
−0.019 (−0.103 to 0.064) |
−0.065 (−0.169 to 0.04) |
0.099 (−0.086 to 0.286) |
0.64 (0.05 to 8.03) |
3.31 (0.9 to 12.98) |
| Rituximab combi | −0.059 (−0.185 to 0.066) |
0.007 (−0.101 to 0.114) |
−0.019 (−0.096 to 0.057) |
0.126
(0.043 to 0.208) |
0.073 (−0.083 to 0.232) |
0.56 (0.04 to 7.91) |
2.38 (0.71 to 8.47) |
| Sarilumab 150 mg combi | 0.051 (−0.051 to 0.153) |
0.037 (−0.063 to 0.138) |
−0.036 (−0.114 to 0.043) |
0.04 (−0.051 to 0.13) |
−0.06 (−0.194 to 0.075) |
2.38 (0.18 to 78.26) |
1.72 (0.62 to 5.24) |
Models: ACR response and DAS28 <2.6 using RD model with fixed effects (FEM); HAQ using CFB model with FEM; SI and SAE using logit model (OR) with FEM; italic text: in favour of sarilumab 200 mg combination; roman text: two treatment options are comparable.
ACR, American College of Rheumatology; CFB, change from baseline; Combi, combination; DAS, Disease Activity Score; DIC, deviance information criterion; FEM, fixed-effects model; HAQ-DI, Health Assessment Questionnaire Disability Index; IR, inadequate response; MTX, methotrexate; RD, risk difference; SAEs, serious adverse events; SC, subcutaneous; SI, serious infections; csDMARD, conventional disease-modifying antirheumatic drugs; diff, difference; mTSS, modified total sharp score; rRAM, regression with random effects model.