Lenabasum fails efficacy outcomes in diffuse cutaneous systemic sclerosis, may improve FVC
Healio Rheumatology discusses the findings of a new study presented at the EULAR 2021 Congress by Robert F. Spiera, MD, rheumatologist and Director of the Vasculitis and Scleroderma Program at HSS.
According to Dr. Spiera, although lenabasum failed to meet its efficacy endpoint in a trial of patients with diffuse cutaneous systemic sclerosis, a post-hoc analysis suggests an impact on forced vital capacity (FVC).
To examine the efficacy, safety and tolerability of lenabasum compared with placebo, Dr. Spiera and colleagues conducted the double-blind, randomized, phase-3 RESOLVE-1 trial. Study participants were allowed to receive background immunosuppressive therapies because it “reflects real-world clinical practice in the treatment of systemic sclerosis,” Dr. Spiera explained.
The researchers found that mycophenolate also impacted outcomes. Dr. Spiera noted, “Patients who entered the trial on mycophenolate were more likely to have a more favorable response with regard to FVC, whereas other features, including the region they came from or disease duration did not. Baseline FVC also came up statistically significant in this model.”
Dr. Spiera concluded, “Evidence for an effect of lenabasum on forced vital capacity [FVC] was suggested by post-hoc analyses that considered the effect of background immunosuppressive therapies on outcomes.”
He added, “Results from the post-hoc analyses will require confirmation in additional studies to determine the potential of lenabasum for treating patients with systemic sclerosis. Treatment with lenabasum was safe and well-tolerated in this study.”
Read the full article at Healio.com.