HMN 2025: How Stapokibart is found to be superior to placebo for severe chronic rhinosinusitis with polyps

In adults with severe chronic rhinosinusitis with nasal polyps treated with a daily intranasal corticosteroid, the anti-interleukin 4R? 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 ?g 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% with stapokibart versus 1.1% with placebo). In the stapokibart group, there were higher rates of arthralgia (7.8% versus 0% with placebo) and hyperuricemia (5.6% versus 1.1%).

“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.

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