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. 2016 Oct 6;18:225. doi: 10.1186/s13075-016-1132-9

Table 4.

Median percent change from baseline in biomarker concentration in patients who achieved or did not achieve LDA (DAS28-CRP <3.2) at week 24

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