Sanofi and Regeneron's Dupixent (dupilumab) has shown positive results in a Phase 3 trial, offering renewed hope for patients with chronic spontaneous urticaria (CSU). The LIBERTY-CUPID Study C evaluated Dupixent in patients with uncontrolled CSU despite antihistamine treatment, confirming earlier findings and paving the way for a potential FDA resubmission.
The double-blind, placebo-controlled trial involved 151 patients aged six years and older who were biologic-naïve, meaning they had not previously been treated with omalizumab. Participants received either Dupixent or a placebo in addition to standard-of-care antihistamines. The primary endpoint was the change from baseline in itch severity at 24 weeks, while a key secondary endpoint assessed changes in both itch and hives.
Significant Reduction in Itch and Hives
Results at 24 weeks demonstrated a significant reduction in both itch and urticaria activity in the Dupixent group. Patients treated with Dupixent experienced an 8.64-point reduction in itch severity compared to a 6.10-point reduction in the placebo group (p=0.02). Furthermore, there was a 15.86-point reduction in urticaria activity (itch and hive severity) with Dupixent, versus an 11.21-point reduction with placebo (p=0.02).
Notably, 30% of patients receiving Dupixent reported no urticaria, indicating a complete response, compared to only 18% in the placebo group (p=0.02).
Safety Profile Consistent with Previous Studies
The safety profile of Dupixent in this trial was consistent with its established safety record in approved dermatological indications. Treatment-emergent adverse events occurred in 53% of patients in both the Dupixent and placebo groups. The most common adverse events observed with Dupixent included injection site reactions (12% vs. 4% with placebo), accidental overdose (7% vs. 3%), and COVID-19 infection (8% vs. 5%).
Implications for CSU Treatment
These positive results reinforce the potential of Dupixent as a new treatment option for CSU patients who do not respond to standard antihistamine therapy. "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, M.D., Ph.D., chief medical officer and global head of development at Sanofi.
With these data, Sanofi and Regeneron plan to resubmit their application to the FDA, seeking approval for Dupixent in CSU. If approved, Dupixent would be the first targeted therapy for CSU in the US in a decade, offering a much-needed alternative for patients with this debilitating condition. Currently, Japan is the only country where Dupixent is approved for CSU.
