Data from the LIBERTY-CUPID Study C confirms the benefits of dupilumab (Dupixent) in reducing itch and disease activity among patients with uncontrolled chronic spontaneous urticaria (CSU) who are biologic-naive. The study, one of three phase 3 trials in the LIBERTY-CUPID program, supports findings from LIBERTY-CUPID Study A, which served as the basis for dupilumab's approval in CSU patients aged 12 years and older in Japan.
Dietmar Berger, MD, PhD, chief medical officer and global head of Development at Sanofi, stated, "The positive pivotal data from this study reinforce the potential of [dupilumab] to offer a new treatment option for the many people suffering from chronic spontaneous urticaria who do not respond to standard-of-care antihistamines. With clinically meaningful reductions in itch and hives for patients receiving [dupilumab], we look forward to sharing these data with the FDA to bring [dupilumab] to patients with CSU in the US as soon as possible."
Study C Results
Topline data from Study C indicated that dupilumab met both primary and key secondary endpoints in treating patients with uncontrolled, biologic-naive CSU receiving background antihistamine therapy. The study involved 151 patients, and dupilumab was associated with an 8.64-point reduction in itch severity from baseline to week 24, compared to a 6.10-point reduction with placebo (P = .02).
Analysis of key secondary endpoints revealed a 15.86-point reduction in urticaria activity severity from baseline to week 24 with dupilumab, versus an 11.21-point reduction with placebo (P = .02). Sanofi also highlighted that 30% of dupilumab-treated patients achieved complete response, compared to 18% in the placebo group (P = .02).
Safety Profile
Safety results were consistent with the established safety profile of Dupixent in its approved dermatological indications. Adverse events observed in 5% or more of dupilumab-treated patients compared to placebo included injection site reactions (12% vs 4%), accidental overdose (7% vs 3%), and COVID-19 infection (8% vs 5%).
Expert Commentary
George D. Yancopoulos, MD, PhD, board co-chair, president, and chief scientific officer at Regeneron, commented, "Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that appear without warning and disrupt their lives. With a nearly 50% reduction in itch and urticaria activity scores compared to placebo, these positive phase 3 results reaffirm the potential of [dupilumab] to bring relief and its well-established safety profile to those living with this chronic inflammatory skin disease."
