Romilkimab shows potential for systemic sclerosis in phase 2 trial
Romilkimab showed significant effects on skin changes in patients with systemic sclerosis, according to phase 2 trial results published in the Annals of the Rheumatic Diseases.
In this double-blind, proof-of-concept, phase 2 study, 97 patients aged ≥18 years with diffuse cutaneous SSc (dcSSc) were randomized to receive romilkimab (n = 48) or placebo (n = 49) for 24 weeks. Change in modified Rodnan skin score from baseline to week 24 were recorded.
The least squares mean change from baseline to 24 weeks was -4.76 for patients taking romilkimab compared with -2.45 for patients taking placebo.
Treatment-emergent adverse events were similar between the groups with 84% and 80% reported in the placebo and romilkimab groups, respectively. One patient in the romilkimab group died from scleroderma renal crisis and 1 patient in the placebo group as a result of cardiomyopathy; both were not considered treatment related.
Allanore Y, Wung P, Soubrane C, et al. A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis. Ann Rheum Dis. 2020; doi: 10.1136/annrheumdis-2020-218447.