Chronic spontaneous urticaria (CSU) affects approximately 270,000 adults and adolescents aged 12 and older in the European Union, manifesting as unpredictable outbreaks of debilitating hives and intense itch that disrupt daily life. For many, standard first-line treatments like H1 antihistamines provide insufficient relief, leaving patients in cycles of discomfort and frustration. In a landmark development, Sanofi and Regeneron Pharmaceuticals have secured European Commission approval for Dupixent (dupilumab), marking the first targeted biologic therapy for moderate-to-severe CSU in over a decade.
Approved as an add-on to antihistamines for patients aged 12 and above who are symptomatic despite H1 antihistamines and naive to anti-IgE therapies, Dupixent represents a paradigm shift. This fully human monoclonal antibody specifically blocks the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), key cytokines fueling the type 2 inflammation underlying CSU. Unlike broad immunosuppressants, Dupixent’s targeted mechanism aims to alleviate symptoms without broadly compromising the immune system, positioning it as a potential first-line biologic option.
The approval hinges on robust data from the phase 3 LIBERTY-CUPID program, comprising three double-blind, placebo-controlled trials. In Studies A and C (total n=284; patients aged 12+ naive to anti-IgE), Dupixent + antihistamines significantly outperformed placebo at week 24. The primary endpoint—change in weekly urticaria activity score (UAS7, combining itch and hives on a 0-42 scale)—dropped markedly, with least-squares mean differences of -10.3 and -12.5 points, respectively. Secondary outcomes reinforced efficacy: itch severity (weekly score 0-21) improved by -5.4 to -6.4 points, hive severity by -4.9 to -6.1 points. Notably, 30-45% of Dupixent patients achieved well-controlled disease (UAS7 ≤6), versus 14-20% on placebo, while complete responses (UAS7=0) reached 20-28% compared to 6-8%. Study B (n=108; anti-IgE inadequate responders) bolstered safety data without primary efficacy readouts. Results from Studies A and B were published in The Journal of Allergy and Clinical Immunology.
Safety aligns with Dupixent’s profile across indications, including injection-site reactions, conjunctivitis, arthralgia, and eosinophilia. In CSU trials, additional events like induration and hematoma at injection sites occurred, but no new signals emerged. Common adverse events (≥5% vs. placebo) included COVID-19, hypertension, and CSU flares. Now approved for seven EU indications, Dupixent is also cleared for CSU in the US and Japan. Ongoing trials explore its role in other pruritic conditions, underscoring its versatility. For eligible patients, this debut offers a beacon of control in a field starved for progress.
Link: https://www.sanofi.com/en/media-room/press-releases/2025/2025-11-25-06-00-00-3194015
