Dupixent Shows Positive Phase 3 Results in Allergic Fungal Rhinosinusitis (AFRS)

Dupixent Shows Positive Phase 3 Results in Allergic Fungal Rhinosinusitis (AFRS)

By, Admin 10 November 2025

Sanofi and Regeneron have announced positive topline results from the pivotal Phase 3 LIBERTY-AFRS-AIMS study (NCT04684524) evaluating the investigational use of Dupixent (dupilumab) in adults and children aged six years and older with allergic fungal rhinosinusitis (AFRS).

The study met all primary and secondary endpoints, demonstrating significant improvements across measures of sinus opacification, nasal congestion, and nasal polyps compared with placebo. The results mark the first-ever positive Phase 3 data in AFRS, a rare and difficult-to-treat subtype of chronic rhinosinusitis.

The findings will be presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2025 Annual Scientific Meeting in Orlando, Florida.

Regulatory Update

The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent in AFRS for patients aged six years and above. If approved, AFRS would become the ninth indication for Dupixent in the United States.

Clinical Outcomes

In the 52-week study involving 62 participants:

  • Sinus opacification scores improved by 50.0% with Dupixent versus 9.8% with placebo (p<0.0001).
  • Nasal congestion/obstruction improved by 66.7% at 24 weeks and 80.6% at 52 weeks, compared to 25.3% and 11.1% with placebo, respectively (p<0.0001).
  • Nasal polyp size was reduced by 60.8% at 24 weeks and 62.5% at 52 weeks, versus 15.2% and 3.6% with placebo (p<0.0001).
  • Patients receiving Dupixent had a 92% lower risk of requiring systemic corticosteroids or surgery (p=0.0010).

Safety Profile

The safety outcomes were consistent with previous Dupixent studies in respiratory indications.

  • Adverse events occurred in 70% of Dupixent patients versus 79% in the placebo group.
  • The most common side effects included COVID-19 (15% vs. 14%) and nosebleed (12% vs. 4%).
  • Serious adverse events occurred in 0% of Dupixent patients compared with 7% in placebo.

Expert Perspective

“This is the first positive Phase 3 trial for an investigational treatment specifically targeting AFRS,” said Dr. Amber U. Luong, Professor and Vice Chair for Academic Affairs, Department of Otorhinolaryngology, McGovern Medical School, University of Texas Health Science Center.

“Dupixent’s ability to reduce hallmark symptoms and lower the risk for surgery or corticosteroid use by 92% provides strong evidence that IL-4 and IL-13 are key drivers of this disease.”

About Allergic Fungal Rhinosinusitis (AFRS)

AFRS is a chronic, type 2 inflammatory disease of the sinuses triggered by hypersensitivity to fungi such as Aspergillus. It is most prevalent in warm, humid regions and often leads to nasal polyps, congestion, loss of smell, and bone erosion. Current treatment options rely on surgery and long-term steroid use, with frequent recurrence.

About Dupixent (dupilumab)

Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways, key drivers of type 2 inflammation. It is approved in over 60 countries for various inflammatory and allergic diseases, including:

  • Atopic dermatitis
  • Asthma
  • Chronic rhinosinusitis with nasal polyps
  • Eosinophilic esophagitis
  • Prurigo nodularis
  • Chronic spontaneous urticaria
  • COPD
  • Bullous pemphigoid

Over one million patients have been treated with Dupixent globally.

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