Novel Biologic Promising in Mid-Stage Scleroderma Trial
MedPage Today reports on study findings available online in Annals of the Rheumatic Diseases which found anti-interleukin agent romilkimab demonstrated significant benefits on skin fibrosis among patients with systemic sclerosis in a Phase II trial.
HSS rheumatologist Robert F. Spiera, MD who was not involved in the study, provided comments on the results, noting, "This was a really interesting study looking at a novel strategy for patients with early diffuse systemic sclerosis, which is a real challenge in terms of identifying effective therapies.” He cited, “This was a trial design that is very impressive to me in the sense that they did what we do in the real world, which was to allow background therapy.” Dr. Spiera added, "Here they were adding the experimental treatment to standard of care therapy, meaning that all patients were able to receive such therapies, which could in theory make it harder to demonstrate that the study medication was having a beneficial effect."
While the study was limited by its brief duration, the impact on skin met the prespecified endpoint, which is the first time that this has been achieved in a Phase II study in diffuse cutaneous systemic sclerosis. "It definitely showed signals of efficacy and was acceptable in terms of safety. This would warrant a further look in a large Phase III clinical trial," he concluded.
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