A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis.

Another randomised study (ASSET) showed that abatacept was associated with a numerically greater improvement in adjusted mRSS (primary endpoint) than placebo at 12 months (mean (SE): ‒6.24 (1.14) vs ‒4.49 (1.14); p=0.28), but this study failed to reach statistical significance. 29 It is not possible to determine if different mechanism of action between agents accounted for the variable results, but it must be noted that the primary analyses in our study were based on prespecified one-sided compared with two-sided alpha testing in faSScinate and ASSET.

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Periostin also showed a strong trend for greater decline with romilkimab versus placebo ( figure 3B ).

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