Most secondary end points did not support the results of the analysis for the primary end point
THURSDAY, Sept. 8, 2022 (HealthDay News) — Patients with systemic lupus erythematosus (SLE) receiving litifilimab, a humanized monoclonal antibody that binds to blood dendritic cell antigen 2, versus placebo have a greater reduction in the number of swollen and tender joints at 24 weeks, according to a study published in the Sept. 8 issue of the New England Journal of Medicine.
Richard A. Furie, M.D., from Northwell Health in Great Neck, New York, and colleagues conducted a phase 2 trial of litifilimab among patients with SLE. After modification to the initial trial design, adults with SLE, arthritis, and active skin disease were randomly assigned to receive litifilimab or placebo. The change from baseline in the total number of active joints was measured at week 24 as the primary end point. The primary analysis was conducted in 102 participants who received 450 mg litifilimab or placebo.
The researchers found that the least-squares mean change from baseline to week 24 in the total number of active joints was −15.0 ± 1.2 and −11.6 ± 1.3 with litifilimab and placebo, respectively (mean difference, −3.4). The results of the analysis of the primary end point were not supported by most of the secondary end points.
“Larger and longer trials are necessary to determine the effect and safety of litifilimab in patients with SLE,” the authors write.
The study was funded by Biogen, the manufacturer of litifilimab.
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