Dr James Q Del Rosso shares insights on the latest FDA-approved indication for Dupixent (dupilumab), now approved for chronic spontaneous urticaria (CSU), highlighting key clinical data and dosing information

Sanofi and Regeneron Pharmaceuticals’ Dupixent expands therapeutic options for the management of chronic spontaneous urticaria (CSU) in patients aged 12 years and older who remain symptomatic despite H1 antihistamine therapy. An injectable monoclonal antibody targeting IL-4 and IL-13 cytokines, Dupixent brings a familiar mechanism of action into the CSU treatment arsenal.

CSU Treatment Landscape

Chronic spontaneous urticaria affects up to 1.4% of the global population and is characterized by recurrent, unpredictable episodes of intensely itchy wheals (hives) and/or angioedema. For patients unresponsive to antihistamines, CSU can be debilitating, leaving limited options for symptom control until now.

Clinical Trial Insights

Approval is backed by multiple randomized, placebo-controlled phase 3 trials known as the CUPID program (Studies A, B, and C). In Study A, involving omalizumab-naïve patients, Dupixent demonstrated statistically significant improvements in the Urticaria Activity Score over 7 days (UAS7), reducing symptoms by an average of 20.5 points compared to 12 points with placebo (P = .0003). Significant improvements were also observed in the Itch Severity Score (ISS7) and Hives Severity Score (HSS7).

In Study B, which included omalizumab-incomplete responders and intolerant patients, Dupixent again showed meaningful clinical benefit with a 14.4-point reduction in UAS7 compared to 8.5 points with placebo (P = .0390), although ISS7 improvements were not statistically significant.

Dr Del Rosso also notes the importance of Study C, which further reinforced Dupixent's clinical benefit in biologic-naïve patients. In Study C, Dupixent achieved significant improvements in both UAS7 and ISS7 scores versus placebo at 24 weeks, with 41% of Dupixent-treated patients achieving well-controlled disease (UAS7 ≤6) compared to 23% with placebo (P = .005), offering additional confidence in its efficacy across patient populations.

Dosing for CSU follows established protocols: for patients aged 12 years and older, a loading dose based on body weight (400 mg for 30 to <60 kg; 600 mg for ≥60 kg), followed by maintenance injections every 2 weeks.

Safety Profile

Pooled safety data from the three CUPID studies demonstrated a favorable safety profile consistent with Dupixent’s established tolerability. The most commonly reported adverse events included injection-site reactions, nasopharyngitis, and mild CSU exacerbations. Anti-drug antibodies were low and did not impact treatment outcomes.

Future Outlook

With this new indication, Dupixent continues to broaden its reach across type 2 inflammatory diseases, already approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease. The CSU approval reinforces Dupixent’s role as a versatile treatment option in clinical practice.

Maurer M, Casale TB, Saini SS, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): two randomized, double-blind, placebo-controlled, phase 3 trials. J Allergy Clin Immunol. 2024;154(1):184–194. doi:10.1016/j.jaci.2024.01.028