Median per cent change from baseline in biomarker concentrations at week 24 in ACR50, ACR70, DAS28-CRP and CDAI LDA responder/non-responder patients
| Endpoint | Treatment q2w+csDMARDs | Population | Median per cent change (Q1, Q3) from baseline at week 24 | ||
| CRP | MMP-3 | OC | |||
| ACR50 | Sarilumab 150 mg | Responder n=50 | −88.4 (−98.1, 54.7) | −49.3 (−71.2, –22.2)* | 8.3 (−5.6, 52.3)† |
| Non-responder n=47 | −77.5 (−94.3, –21.4) | −28.6 (−46.0, 20.1) | 3.1 (−15.6, 24.1) | ||
| Sarilumab 200 mg | Responder n=55 | −97.1 (−99.1, –91.9)† | −49.4 (−76.6, –11.1) | 11.7 (−11.7, 34.6) | |
| Non-responder n=42 | −94.6 (−98.3, –86.9) | −43.5 (−79.1, 7.2) | 2.7 (−14.5, 29.1) | ||
| ACR70 | Sarilumab 150 mg | Responder n=27 | −91.6 (−98.6, –71.4)† | −59.7 (−71.8, –30.6)* | 21.9 (−5.8, 61.1)† |
| Non-responder n=70 | −78.1 (−95.2, –21.4) | −29.2 (−50.6, 13.6) | 3.5 (−9.8, 25.2) | ||
| Sarilumab 200 mg | Responder n=23 | −96.6 (−99.0, –88.3) | −54.3 (−71.4, –15.9) | 19.0 (−11.7, 34.6) | |
| Non-responder n=74 | −96.5 (−98.9, –87.4) | −46.5 (−79.7, –2.7) | 3.5 (−14.9, 30.8) | ||
| DAS28-CRP LDA | Sarilumab 150 mg | Responder n=46 | −92.6 (−98.0, –70.9)* | −49.3 (−71.2, –20.7)* | 11.1 (1.0, 47.6)† |
| Non-responder n=51 | −74.0 (−92.7, –1.4) | −29.7 (−48.1, 16.5) | 2.2 (−15.6, 25.9) | ||
| Sarilumab 200 mg | Responder n=55 | −96.6 (−99.0, –92.1)* | −48.5 (−76.6, –7.0) | 9.7 (−15.0, 33.4) | |
| Non-responder n=42 | −97.3 (−98.9, –74.1) | −49.6 (−79.7, –3.1) | 5.1 (−10.1, 30.0) | ||
| CDAI LDA | Sarilumab 150 mg | Responder n=46 | −82.0 (−97.2, –25.2) | −34.75 (−65.7, –3.3) | 10.8 (−6.3, 45.1) |
| Non-responder n=51 | −90.2 (−97.1, –25.2) | −34.6 (−55.0, –8.2) | 3.7 (−13.7, 26.5) | ||
| Sarilumab 200 mg | Responder n=49 | −96.10 (−99.0, –91.4) | −49.4 (−76.6, −15.9) | 3.7 (−14.6, 31.0) | |
| Non-responder n=48 | −97.6 (−98.7, −87.1) | −44.7 (−79.4, 6.9) | 10.9 (−12.3, 33.6) | ||
*Unadjusted P<0.01 versus non-responders (using ANOVA-type for CRP and MMP-3 and RANK-ANCOVA for OC).
†Unadjusted P<0.05 versus non-responders.
ACR50/70, American College of Rheumatology 50%/70% improvement; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-CRP, 28-joint disease activity score by CRP; CDAI, clinical disease activity index; LDA, low disease activity; MMP, matrix metalloproteinase; n , number of patients in each response category in the biomarker population; sample sizes can vary from one biomarker to another; OC, osteocalcin; q2w, every 2 weeks.