SAN FRANCISCO – Dupilumab, an anti-inflammatory drug already approved for use in the United States, met its efficacy endpoints for treating chronic rhinosinusitis with nasal polyps in a pivotal trial with 276 patients.
The results make it likely that dupilumab (Dupixent) will receive a new indication from the Food and Drug Administration, pending similar results in a second pivotal trial for nasal polyps that researchers will report soon. Dupilumab, which works by blocking a receptor for both interleukin 4 and interleukin 13 and thereby shutting down type 2 inflammation, is alreadyin the United States for treating atopic dermatitis and asthma.
Type 2 inflammation drives polyp formation in patients with chronic rhinosinusitis that can produce severe nasal congestion, breathing difficulty, and substantially reduced quality of life.
In the new trial, the drug showed efficacy by significantly improving both the nasal congestion score reported by patients and the nasal polyp score measured by sinus endoscopy after 24 weeks on treatment, when compared with control patients on placebo,, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Patients enrolled in the study had chronic, severe sinusitis and nasal polyps that remained uncontrolled despite prior surgery, for 75% of enrolled patients, or treatment with systemic corticosteroids, used on about 90% of the patients within the prior 2 years.
During the 24 weeks of treatment, 23% of patients in the control arm had to restart systemic corticosteroid treatment or have surgery, compared with 7% of patients on dupilumab treatment, a statistically significant difference.