Stapokibart Demonstrates Superior Effectiveness Over Placebo for Severe Chronic Rhinosinusitis with Polyps
Clinical trials reveal that Stapokibart outperforms placebo in reducing polyp size and symptoms in adults with severe chronic rhinosinusitis, offering new hope for effective treatment.
Recent clinical research published in the Journal of the American Medical Association has shown that Stapokibart, an anti-interleukin 4Rα monoclonal antibody, significantly improves conditions in adults suffering from severe chronic rhinosinusitis with nasal polyps. The double-blind, randomized trial involved 180 patients who received standard intranasal corticosteroid therapy along with either Stapokibart or placebo over a 24-week period.
Participants treated with Stapokibart exhibited a marked reduction in nasal polyp size, with the least-squares mean change of −2.6 points compared to just −0.3 in the placebo group. This effect was even more pronounced among individuals with eosinophilia, showing a decrease of −3.0 versus −0.4, respectively. Additionally, improvements were noted in nasal congestion scores, decreasing by −1.2 points in the Stapokibart group compared to −0.5 in the placebo group across the overall population.
Safety profiles indicated that serious adverse events were infrequent, occurring in 2.2% of Stapokibart recipients versus 1.1% of placebo recipients. However, higher rates of arthralgia and hyperuricemia were observed among those receiving Stapokibart.
The study's authors concluded that Stapokibart provides rapid, significant relief by reducing nasal polyp size and alleviating main symptoms, thereby improving patients' quality of life. Several researchers involved declared associations with KeyMed Biosciences, the manufacturer of Stapokibart.
This promising research suggests Stapokibart could become a vital addition to treatment protocols for severe chronic rhinosinusitis with nasal polyps when used alongside standard corticosteroid therapy.
Source: https://medicalxpress.com/news/2025-08-stapokibart-superior-placebo-severe-chronic.html
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