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Stapokibart shows nasal symptom reduction in pediatric seasonal allergic rhinitis case series

Stapokibart shows nasal symptom reduction in pediatric seasonal allergic rhinitis case series
Photo by Navy Medicine / Unsplash
Key Takeaway
Consider stapokibart's symptom reduction signal in pediatric SAR as preliminary, uncontrolled evidence.

A retrospective case series evaluated stapokibart in 20 patients under 18 years old with moderate-to-severe seasonal allergic rhinitis. The intervention was stapokibart treatment, starting with a 600 mg dose followed by a 300 mg maintenance dose after 2 weeks, compared to baseline. The primary outcome was change in visual analog scale (VAS) scores for nasal symptoms after 1 month.

All 20 patients (20/20) demonstrated significant reductions in nasal VAS scores compared with baseline after 1 month of treatment, with a reported P value of <0.05. The specific effect size was not reported. Secondary outcomes included symptom control during the allergic season and drug safety, but results for these were not detailed.

Safety and tolerability data, including adverse events, serious adverse events, and discontinuations, were not reported. Key limitations include the retrospective design, the case series methodology which lacks a control group, and the small sample size of 20 patients. The funding source and conflicts of interest were not reported.

Given the uncontrolled, observational nature of this evidence, the findings should be interpreted as preliminary. They suggest a signal of efficacy for stapokibart in reducing nasal symptoms in this pediatric population, but do not establish causality or comparative effectiveness. Controlled trials are needed to confirm these observations and fully assess the benefit-risk profile.

Study Details

Study typeCohort
EvidenceLevel 3
PublishedMar 2026
View Original Abstract ↓
ObjectiveThe objective of this work was to investigate the efficacy and safety of stapokibart, an anti-IL-4Rα monoclonal antibody, in patients under 18 years of age with moderate-to-severe seasonal allergic rhinitis (SAR).MethodsA retrospective analysis was conducted on 20 children with severe SAR who received stapokibart treatment during spring (March–April) and autumn (August–October) of 2025. The regimen consisted of an initial dose of 600 mg (two subcutaneous injections), followed by a maintenance dose of 300 mg (one injection) after 2 weeks, after which the treatment was discontinued. Children with comorbid atopic dermatitis (AD) (n = 8) were treated according to the AD protocol. The primary efficacy endpoint was the change in visual analog scale (VAS) scores for nasal symptoms after 1 month of treatment compared with baseline. Secondary endpoints included symptom control during the allergic season and drug safety.ResultsAll 20 pediatric patients demonstrated significant reductions in nasal VAS scores compared with baseline after 1 month of treatment (P 
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