Table 4.
Placebo | Sarilumab 200 mg q2w | |||
---|---|---|---|---|
LDA achieved (n = 37) |
LDA not achieved (n = 91) |
LDA achieved (n = 72) |
LDA not achieved (n = 59) |
|
CRP | ||||
Week 2 | 1.2 | −2.9 | −95.0** | −83.5 |
Week 24 | −31.9** | −4.2 | −96.9** | −90.2 |
C1M | ||||
Week 2 | 4.5 | 2.2 | −55.8* | −45.1 |
Week 24 | −16.8* | −4.3 | −65.7** | −54.1 |
C2M | ||||
Week 2 | 0 | 3.4 | 0* | −14.3 |
Week 24 | 0 | 3.5 | 0 | −6.7 |
MMP-3 | ||||
Week 2 | −2.0 | 2.3 | −7.2 | −3.3 |
Week 24 | −9.7 | 0.4 | −47.2 | −34.2 |
OPG | ||||
Week 2 | −5.1 | 1.6 | −6.5* | −0.9 |
Week 24 | −1.9 | −1.8 | −4.6 | 0.9 |
sRANKL | ||||
Week 2 | −4.7 | −0.8 | −7.9 | −2.3 |
Week 24 | −16.2* | −0.8 | −39.7 | −25.8 |
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).
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