Chronic Sinusitis Drug Shows Promise in Phase 2 Trial

A phase 2 trial produced positive results for a therapeutic treatment of adult patients suffering from moderate-to-severe chronic sinusitis with nasal polyposis who do not respond to intranasal corticosteroids.

Dupilumab inhibits signaling from 2 key cytokines, IL-4 and IL-13, which are mandatory for the T helper 2 (Th2) immune response. This is believed to be a pathway in inflammation with chronic sinusitis with nasal polyps and asthma and atopic dermatitis.

“Despite current treatment options, including surgery to remove polyps, some patients with chronic sinusitis with nasal polyposis continue to experience difficult symptoms, including nasal congestion, decreased or lost sense of smell, and facial pain, which can negatively impact their quality of life,” said study lead author Claus Bachert, MD, PhD. “In addition, patients with this condition may experience sleep disturbances and decreased productivity. This study, which also included patients with co-morbid asthma, supports previous observations that chronic sinusitis with nasal polyposis and asthma may share a core allergic inflammatory process driven by the IL-4 and IL-13 pathways.”

During the phase 2 randomized double blind study, researchers enrolled 60 adults suffering from chronic sinusitis with nasal polyposis resistant to intranasal corticosteroids.

After a 4 week run-in period where patients received mometasone furoate nasal spray (MFNS), investigators injected 300-mg of dupilumab or a placebo once a week for 16 weeks after an initial dosage of 600-mg, and continued using MFNS daily.

Patients eligible for the study had bilateral nasal polyposis and showed chronic symptoms of sinusitis, even after at least 2 months of intranasal corticosteroid. There were 58% of patients who participated in the study that had previous nasal surgery for their condition.

The results of the study conducted by Sanofi and Regeneron Pharmaceuticals was published in the Journal of the American Medical Association (JAMA).