Table 3.
Median percent change from baseline in biomarker concentration in ACR50 responder and nonresponder patients at week 24
| Placebo | Sarilumab 200 mg q2w | |||
|---|---|---|---|---|
| ACR50 responder (n = 34) |
ACR50 nonresponder (n = 94) |
ACR50 responder (n = 67) |
ACR50 nonresponder (n = 64) |
|
| CRP | ||||
| Week 2 | 8.5 | −3.3 | −94.2 | −87.5 |
| Week 24 | −40.3** | −4.2 | −96.3 | −94.1 |
| C1M | ||||
| Week 2 | 1.6 | 2.6 | −57.1* | −43.8 |
| Week 24 | −26.7* | −7.2 | −62.8** | −57.0 |
| C2M | ||||
| Week 2 | 0.0 | 3.4 | −4.3 | −4.3 |
| Week 24 | 0.0 | 3.1 | 0.0 | −6.5 |
| MMP-3 | ||||
| Week 2 | −5.1 | 1.9 | −10.8* | −4.4 |
| Week 24 | −6.3 | −1.4 | −50.9 | −30.6 |
| OPG | ||||
| Week 2 | 1.7 | 0.0 | −6.0 | −2.2 |
| Week 24 | 0.0 | −1.8 | −1.1 | −2.0 |
| sRANKL | ||||
| Week 2 | −5.4 | −1.2 | −7.9 | −2.7 |
| Week 24 | −23.6* | −0.8 | −31.4 | −24.9 |
Percent change from baseline in biomarkers transformed in rank was compared between responder and nonresponder patients at week 24 using an analysis of variance (ANOVA)-type method, with response, visit, and response-by-visit interaction as fixed effects, rank-transformed baseline biomarker value and rank-transformed baseline biomarker-value-by-visit interaction as fixed covariates, and assuming an unstructured covariance structure. The model was run separately by treatment group (sarilumab 200 mg q2w and placebo)
ACR American College of Rheumatology
C1M collagen type I MMP-cleaved fragment, C2M collagen type II MMP-cleaved fragment, CRP C-reactive protein, DAS28-CRP 28-joint disease activity score by CRP, LDA low disease activity, MMP matrix metalloproteinase, MTX methotrexate, OPG osteoprotegerin, q2w every 2 weeks, sRANKL soluble receptor activator of nuclear factor-kB ligand. *Nominal p < 0.05 vs nonresponder. **Nominal p < 0.01 vs nonresponder