Clinical observation of stapokibart in patients under 18 years of age with seasonal allergic rhinitis: a case series study of 20 cases

TL;DR

This study shows that stapokibart is effective and safe for treating severe seasonal allergic rhinitis in children under 18.

Contribution

The study provides new evidence on the use of stapokibart in pediatric patients with seasonal allergic rhinitis and comorbid atopic dermatitis.

Findings

All 20 patients showed significant improvement in nasal symptoms after one month of treatment.

Patients with comorbid atopic dermatitis experienced no significant SAR symptom flare-ups during subsequent allergy seasons.

Only one patient reported mild drowsiness, indicating a good safety profile.

Abstract

The 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).

A 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.

All 20 pediatric patients demonstrated significant reductions in nasal VAS scores compared with baseline after 1 month of treatment (P < 0.001). Among the eight patients with comorbid AD, no clinically significant exacerbations of SAR symptoms occurred during subsequent allergy seasons during continued treatment. Only one patient (5%) reported mild drowsiness as an adverse event, with no severe adverse events observed.

In this small case series, stapokibart rapidly and effectively alleviated nasal symptoms of SAR in children and adolescents, and may provide long-term symptom control across allergy seasons for patients with comorbid AD. The treatment demonstrated a good safety profile, offering novel insights into targeted therapy of comorbid allergic diseases in children.

Figures