Spontaneous chronic urticaria improvement seen with Dupixent treatment
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Key takeaways:
- Urticaria patients taking Dupixent experienced an 8.64-point reduction in itch and 15.86-point reduction in urticaria activity.
- Also, 30% of patients had complete disease control.
Patients with chronic spontaneous urticaria experienced a marked improvement with Dupixent treatment, according to phase 3 trial results released by Regeneron.
The randomized, double-blind, placebo-controlled LIBERTY-CUPID phase 3 study included 151 biologic-naïve patients with chronic spontaneous urticaria who all used standard-of-care antihistamines. Patients were randomly assigned to receive Dupixent (dupilumab, Regeneron/Sanofi) or placebo for 24 weeks.
A complete response, defined as no urticaria present, occurred in 30% of the 74 patients taking Dupixent compared with 18% of the 77 using placebo (P = .02).
Furthermore, an 8.64-point reduction in itch severity and a 15.86-point reduction in urticaria activity was found in the treatment arm, compared with 6.1-point and 11.21-point reductions in the placebo arm, respectively (P = .02 for both).
“Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that appear without warning and disrupt their lives,” George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of Dupixent, said in the release. “With a nearly 50% reduction in itch and urticaria activity scores compared to placebo, these positive phase 3 results reaffirm the potential of Dupixent to bring relief and its well established safety profile to those living with this chronic inflammatory skin disease.”
Treatment emergent adverse events occurred in 53% of patients in each study arm. Injection site reactions occurred in 12% of those in the Dupixent arm vs. 4% of the placebo arm, accidental overdose occurred in 7% of the treatment arm vs. 3% of the placebo group and COVID-19 infection occurred in 8% vs. 5%, respectively.
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