Table 3.
LSM change from baseline for efficacy parameters according to baseline IL‐6 tertile in the MONARCH study (week 24)a
| Treatment group | Low IL‐6 (n = 100) | Medium IL‐6 (n = 100) | High IL‐6 (n = 100) | All (biomarker population) (n = 307)b |
|---|---|---|---|---|
| Change in TJC | ||||
| Sarilumab 200 mg every 2 weeks | −18.7 (−20.9, −16.5) | −18.6 (−21.8, −15.4) | −18.6 (−21.2, −16.0) | −18.9 (−20.4, −17.4) |
| Adalimumab 40 mg every 2 weeks | −16.8 (−19.5, −14.1) | −18.8 (−21.6, −15.9) | −15.9 (−18.5, −13.4) | −17.2 (−18.7, −15.6) |
| Change in SJC | ||||
| Sarilumab 200 mg every 2 weeks | −12.8 (−13.9, −11.8) | −13.2 (−15.1, −11.3) | −15.1 (−16.8, −13.4)c | −13.8 (−14.7, −12.9) |
| Adalimumab 40 mg every 2 weeks | −12.7 (−14.0, −11.5) | −14.0 (−15.7, −12.3) | −11.5 (−13.2, −9.9) | −12.9 (−13.8, −11.9) |
| Change in DAS28‐CRPd | ||||
| Sarilumab 200 mg every 2 weeks | −2.5 (−2.8, −2.2)c | −2.8 (−3.2, −2.4)c | −3.5 (−3.8, −3.2)c | −3.0 (−3.2, −2.8)c |
| Adalimumab 40 mg every 2 weeks | −1.8 (−2.2, −1.5) | −2.2 (−2.6, −1.8) | −2.1 (−2.4, −1.8) | −2.1 (−2.3, −1.9) |
| Change in CDAI | ||||
| Sarilumab 200 mg every 2 weeks | −27.1 (−29.6, −24.7) | −28.0 (−31.6, −24.4) | −33.1 (−35.9, −30.3)c | −29.7 (−31.3, −28.1)c |
| Adalimumab 40 mg every 2 weeks | −25.0 (−27.9, −22.1) | −27.4 (−30.7, −24.2) | −25.9 (−28.6, −23.2) | −26.4 (−28.0, −24.7) |
Values are the least squares mean (LSM) change from baseline (95% confidence interval). The LSM was derived from a linear regression performed on the change from baseline in efficacy measures, with baseline efficacy value, treatment, and study randomization stratification factors (region) as fixed effects, in each biomarker tertile. See Table 1 for other definitions.
Includes the overall biomarker population, regardless of whether patients had baseline IL‐6 values available.
Nominal P < 0.05 versus adalimumab.
For IL‐6 tertile–by‐treatment group interaction, nominal P < 0.05 for high or medium tertile versus low tertile, by linear regression with treatment, study randomization stratification factors (region), baseline efficacy value, IL‐6 tertile at baseline, and IL‐6 tertile at baseline–by‐treatment interaction as fixed effects.