TOPLINE

Dupilumab significantly reduced sinus opacification, symptoms, and the need for corticosteroids and improved quality of life in patients with allergic fungal rhinosinusitis (AFRS), findings from a phase 3 trial revealed.

METHODOLOGY

• Researchers conducted a 52-week phase 3 trial across 27 centers in the Americas and Asia to evaluate the safety and efficacy of dupilumab in patients with AFRS.
• Overall, 62 patients (mean age, 39.8 years; 27.4% women) were randomly assigned to receive either weight-tiered dupilumab or matching placebo for 52 weeks, with stratification by age, time since last surgery, disease pattern, and country.
• The primary endpoint was sinus opacification, assessed as a change in the Lund-Mackay (LMK)-CT score (range, 0-24; a higher score indicates greater sinus opacification) from baseline to week 52.
• Secondary endpoints included nasal congestion, sense of smell, quality of life, and the need for systemic corticosteroids or surgery, tested in a hierarchical order.

TAKEAWAY

• Dupilumab significantly improved LMK-CT scores compared with placebo at week 52 (least-squares mean difference, -7.36; P < .001), corresponding to a mean reduction of 50.0% vs 9.8% from baseline.
• Dupilumab reduced the risk of receiving systemic corticosteroids and/or undergoing sinonasal surgery by 92% compared with placebo (risk difference, -29.1%; P = .0010).
• Dupilumab significantly improved nasal congestion, nasal polyp and total symptom scores, sense of smell, and quality of life compared with placebo at week 24 (P < .05 for all); improvements in nasal congestion, polyp scores, and quality of life at week 24 were further enhanced by week 52 (P < .001 for all).
• Treatment-emergent adverse events occurred at similar rates with dupilumab and placebo (69.7% and 78.6%, respectively), and no deaths were reported in either group.

IN PRACTICE

“Dupilumab has the potential to become the first targeted therapy to reduce the disease burden of AFRS, shifting the treatment paradigm from alleviating symptoms to treating the underlying perpetuation of the disease,” the authors wrote.

SOURCE

Amber U. Luong, MD, PhD, with the Department of Otorhinolaryngology - Head and Neck Surgery, McGovern Medical School, UTHealth Houston, Houston, was the corresponding author of the study, which was published online on July 24 in The Journal of Allergy and Clinical Immunology.

LIMITATIONS

The study was limited by the small sample size, partly because of recruitment challenges during the COVID pandemic. The enrollment of Black/African American patients was relatively low overall, although it was comparable to regional rates in North America. Nearly all patients had undergone prior sinonasal surgery, which limited generalizability.

DISCLOSURES

This study was supported by Sanofi and Regeneron Pharmaceuticals. Several authors, including the corresponding author, reported receiving advisory board fees, consultancy fees, clinical trial funding, or speaker fees from Sanofi, Regeneron, and other pharmaceutical companies. Some authors reported being employees of Sanofi or Regeneron Pharmaceuticals and holding potential stock and/or stock options in these companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.