|
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