Dupixent Demonstrates Reduced Symptoms of Chronic Spontaneous Urticaria

Image Credit: Adobe Stock Images/suriya

Results from the confirmatory Phase III LIBERTY-CUPID Study C found that Regeneron and Sanofi’s Dupixent (dupilumab) showed significant potential treating chronic spontaneous urticaria (CSU) in patients who are biologic-naïve and unresponsive to antihistamines. According to the companies, the trial confirms results of from Study A, the first Phase III trial of Dupixent in this setting.¹

“Patients with uncontrolled chronic spontaneous urticaria experience debilitating itch and hives that appear without warning and disrupt their lives,” said George D. Yancopoulos, MD, PhD, board co-chair, president, chief scientific officer, Regeneron, principal inventor of Dupixent, in a press release. “With a nearly 50% reduction in itch and urticaria activity scores compared to placebo, these positive Phase III results reaffirm the potential of Dupixent to bring relief and its well-established safety profile to those living with this chronic inflammatory skin disease.”

The LIBERTY-CUPID Phase III program consisted of Study A, Study B and Study C. Study C, which enrolled 151 children and adults, was a randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of Dupixent as an add-on to standard-of-care antihistamines compared to antihistamines alone. Participants were randomly assigned to receive Dupixent or placebo in addition to the standard-of-care antihistamines. The primary endpoint of the study was a change in itch from baseline at 24 weeks, while the secondary endpoint was the change from baseline in itch and hives at 24 weeks.

Results found that Dupixent reduced itch and urticaria activity scores by 50% compared to placebo. Additionally, patients treated with Dupixent experienced an 8.64-point reduction in itch severity and a 15.86-point reduction in urticaria activity at 24 weeks, compared to a 6.10-point reduction in itch severity and a 11.21-point reduction in urticaria activity for the placebo group. Thirty percent of patients treated with Dupixent reported no urticaria compared to 18% treated with placebo.

The safety results of Study C were consistent with the previously known safety profile of Dupixent. Fifty-three percent of patients in both groups experienced treatment-emergent adverse events (AEs). In Dupixent, more common AEs included injection site reactions, accidental overdose, and COVID-19 infection.¹

Statistics from the National Library of Medicine demonstrate that CSU is most common in people between the ages of 20 and 40 years. Affecting anywhere from 0.5% to 1% of the general population, it is twice as common in women than men.²

“The positive pivotal data from this study reinforce the potential of Dupixent to offer a new treatment option for the many people suffering from chronic spontaneous urticaria who do not respond to standard-of-care antihistamines,” said Dietmar Berger, MD, PhD, chief medical officer, global head of development, Sanofi, in the press release. “With clinically meaningful reductions in itch and hives for patients receiving Dupixent, we look forward to sharing these data with the FDA to bring Dupixent to patients with CSU in the US as soon as possible. With Dupixent now treating 1 million patients across seven approved indications, these new results underscore there are still many more patients that Dupixent can potentially benefit.”

Currently, Japan is the only region where the safety and efficiacy of Dupixent for CSU has been fully evaluated. Full results of the LIBERTY-CUPID study are expected to be submitted to the FDA by the end of the year as per additional data requested for a supplemental Biologics License Application.¹

References

1. DUPIXENT® (DUPILUMAB) PHASE 3 TRIAL CONFIRMS SIGNIFICANT IMPROVEMENTS IN ITCH AND HIVES FOR PATIENTS WITH CHRONIC SPONTANEOUS URTICARIA (CSU). Regeneron. September 11, 2024. Accessed September 12, 2024. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-phase-3-trial-confirms-significant

2. Chronic spontaneous urticaria. NIH. January 16, 2017. Accessed September 12, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5235931/#:~:text=Chronic%20spontaneous%20urticaria%20has%20a,but%20longer%20in%20severe%20cases.&text=The%20condition%20affects%200.5%25%E2%80%931,twice%20as%20often%20as%20men.