|
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