Stapokibart Found to Be Superior to Placebo for Severe Chronic Rhinosinusitis With Polyps
By Lori Solomon HealthDay Reporter
Medically reviewed by Drugs.com
WEDNESDAY, Aug. 20, 2025 -- In adults with severe chronic rhinosinusitis with nasal polyps treated with a daily intranasal corticosteroid, the anti-interleukin 4Rα monoclonal antibody stapokibart improves outcomes, according to a study published online Aug. 18 in the Journal of the American Medical Association.
Shen Shen, from Capital Medical University in China, and colleagues assessed the efficacy and safety of stapokibart as an add-on treatment to intranasal corticosteroids in adults with severe uncontrolled chronic rhinosinusitis with nasal polyps. All 180 patients initiated mometasone furoate nasal spray (100 μg in each nostril daily) and then were randomly assigned (1:1) to stapokibart (300 mg) or placebo every two weeks for 24 weeks.
The researchers found that in the overall population, the least-squares (LS) mean change in nasal polyp score from baseline to week 24 was −2.6 in the stapokibart group versus −0.3 in the placebo group (LS mean difference, −2.3), and in the population with eosinophilia, the change was −3.0 versus −0.4 points, respectively (LS mean difference, −2.5). For nasal congestion, the score from baseline to week 24 in the stapokibart versus placebo groups was −1.2 versus −0.5 points, respectively, in the overall population (LS mean difference, −0.7) and −1.3 versus −0.5 points, respectively, in the population with eosinophilia (LS mean difference, −0.8). Serious adverse events were rare (2.2 percent with stapokibart versus 1.1 percent with placebo). In the stapokibart group, there were higher rates of arthralgia (7.8 percent versus 0 percent with placebo) and hyperuricemia (5.6 versus 1.1 percent).
"Compared with placebo, stapokibart rapidly and significantly reduced nasal polyp size, improved the main symptoms of rhinosinusitis, reduced overall sinus inflammation, and enhanced quality of life in both populations," the authors write.
Several authors disclosed ties to KeyMed Biosciences, the manufacturer of stapokibart.
Abstract/Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted August 2025
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.