Romilkimab delivers in diffuse cutaneous systemic sclerosis

Romilkimab, a novel bispecific immunoglobulin-G4 antibody that binds and neutralizes interleukin (IL)-4/IL-13, shows promise in the treatment of diffuse cutaneous systemic sclerosis (dcSSc), producing significant reduction in skin fibrosis, according to data from a phase II trial.

Ninety-seven adult dcSSc patients with or without immunosuppressive background therapy were randomized to receive either romilkimab (n=48) or placebo (n=49) for 24 weeks.

The primary endpoint of change in modified Rodnan skin score (mRSS) at week 24 was significantly greater with the study drug than with placebo (–4.76 vs –2.45; difference, –2.31, 95 percent confidence interval, –4.32 to –0.31; p=0.0291).

There were no significant differences observed in the secondary endpoints of forced vital capacity (–10 mL with romilkimab vs –80 mL with placebo; p=0.10), diffusing lung capacity for carbon monoxide (–0.12 vs –0.27, respectively; p=0.14), and physical/functional disability (mean Health Assessment Questionnaire-Disability Index score, –0.09 vs –0.12, respectively; p=0.40).

Treatment-emergent adverse event were comparable between romilkimab and placebo (80 percent vs 84 percent), with most events being mild to moderate in severity and rarely leading to discontinuations (three overall).

There were two deaths documented, one due to scleroderma renal crisis in the active treatment group and the other due to cardiomyopathy in the placebo group, but neither was considered treatment related. There were no cardiac safety signals detected with romilkimab.