Dupilumab was found to reduce itch severity and urticaria activity in patients with chronic spontaneous urticaria inadequately controlled by antihistamines in clinical trials.
The U.S. Food and Drug Administration approved dupilumab for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older with symptoms inadequately controlled by histamine-1 antihistamines, according to a press release from Regeneron Pharmaceuticals. Dupilumab is the first targeted therapy approved for CSU in over a decade and the seventh approved indication for the agent in diseases mediated in part by type 2 inflammation.
Approval was based on results from three randomized, placebo-controlled phase III trials (Studies A, B, and C). Studies A (n = 136) and C (n = 148) evaluated dupilumab as add-on therapy in biologic-naive patients symptomatic despite antihistamine use. Both trials met primary and key secondary endpoints, demonstrating significant reductions in itch severity and urticaria activity scores (UAS7) at 24 weeks versus placebo.
Dupilumab also increased the proportion of patients achieving well-controlled disease (UAS7 ≤ 6) or complete response (UAS7 = 0). Study B (n = 108), which enrolled patients with inadequate response or intolerance to anti–immunoglobulin E therapy, didn't meet the U.S. primary endpoint but provided additional safety data.
Safety outcomes were consistent with the known profile of dupilumab. The most common adverse event (≥ 2%) reported more frequently compared with placebo was injection-site reaction. Dupilumab is administered subcutaneously every 2 weeks following an initial loading dose, with dosing based on age and weight in adolescents.
Dupilumab is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling and isn't classified as an immunosuppressant. The agent is currently approved in multiple countries for CSU and other type 2 inflammatory conditions, including atopic dermatitis, asthma, eosinophilic esophagitis, prurigo nodularis, chronic rhinosinusitis with nasal polyps, and chronic obstructive pulmonary disease.
Regulatory submissions for CSU are under review in additional markets, including the European Union.