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About 41% and 30% of patients with chronic spontaneous urticaria (CSU), respectively, achieved well-controlled disease status and complete response when treated with dupilumab.
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According to investigators, positive data from the phase 3 LIBERTY-CUPID (NCT04180488) study C evaluating the use of dupilumab (Dupixent; Sanofi, Regeneron) in patients with uncontrolled chronic spontaneous urticaria (CSU) who are biologic-naïve and receive background therapy with antihistamines demonstrate that dupilumab significantly reduced itch and urticaria activity scores from baseline compared with placebo. In addition, a higher proportion of patients had achieved well-controlled disease status when treated with dupilumab.1
Dupilumab is a fully human monoclonal antibody that inhibits the signaling of the interleukin (IL)-4 and IL-13 pathways, which are 2 of the key drivers of type 2 inflammation that play a major role in multiple related—and often comorbid—diseases. It is not an immunosuppressant. Dupilumab has received regulatory approvals for indications within atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age groups. The treatment is currently undergoing evaluation in phase 3 clinical trials for its potential use in chronic pruritus of unknown origin and bullous pemphigoid.1
Trial Name: Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
ClinicalTrials.gov ID: NCT04180488
Sponsor: Sanofi
Completion Date (Estimated): August 22, 2024
The LIBERTY-CUPID phase 3 study program consists of 3 studies—study A, study B, and study C—which evaluate dupilumab for CSU. Study C was a randomized, double-blind, placebo-controlled clinical study that evaluated the safety and efficacy of dupilumab as an add-on treatment to standard of care antihistamines in patients with CSU aged 6 and older who were not previously treated with a biologic. A total of 151 patients were enrolled and were randomly assigned to receive either subcutaneous injections of dupilumab (n = 74) or placebo (n = 77) with non-sedating histamine-1 antihistamines.1,2
The study’s primary end point was change in itch severity from baseline to week 24, which was measured by a weekly itch severity score (ISS7) on a 0 to 21 scale. Secondary end points at the 24-week point included the change from baseline in itch and hives (measured by the weekly urticaria activity score [UAS7]; 0-42 scale), proportion of patients achieving well-controlled disease status (a UAS7 score of ≤6), and complete response (a UAS7 score of 0).1,2
According to the findings, dupilumab demonstrated significant improvements in all measured areas compared with placebo. Patients on dupilumab reported itch severity score reductions of 8.64, compared with placebo which showed a reduction of 6.10 (P = .02). Additionally, itch and hive activity scores were reduced by 15.86 and 11.21 in the dupilumab and placebo groups, respectively (P = .02). Patients in the dupilumab group also had more improvements in well-controlled disease status (41%) compared with placebo (23%; P = .005) and more patients achieved a complete response (30% vs 18%; P = .02). These results were presented at the 2024 American College of Allergy, Asthma and Immunology Annual Scientific Meeting in Boston, Massachusetts, which was held from October 24 to 28.1,2
Additionally, the investigators observed that the safety results in study C were generally consistent with the known safety profile of dupilumab in its approved dermatological indications. Overall rates of treatment emergent adverse events (AEs) were approximately 53% for both dupilumab and placebo. AEs were more frequently reported by patients who received dupilumab than placebo, and consisted of injection site reactions (12% vs 4%), accidental overdose (7% vs 3%), and COVID-19 infection (8% vs 5%).1
“Chronic spontaneous urticaria is an inflammatory skin condition that affects patients with unpredictable episodes of intense itching and hives, often severely impacting their daily lives. These data confirm results seen in the previous study A and reinforce the potential of [dupilumab] to significantly alleviate symptoms for patients, helping them to better control this challenging disease,” said Thomas B. Casale, MD, professor of internal medicine, Morsani College of Medicine at the University of South Florida, in a news release.1
