A short-course and season-oriented Stapokibart strategy for moderate-to-severe seasonal allergic rhinitis: Real-world evidence from Northern China

Background Seasonal allergic rhinitis (SAR) imposes a substantial disease burden worldwide. In Northern China, Artemisia pollen is the dominant autumn allergen, and many patients with moderate-to-severe SAR remain inadequately controlled despite intranasal corticosteroids and antihistamines. Stapokibart, an IL-4Rα–blocking monoclonal antibody, has shown efficacy in randomized trials, but real-world evidence and season-oriented treatment strategies remain limited. We evaluated the effectiveness and safety of Stapokibart and explored the feasibility of a short-course, season-oriented biologic strategy in SAR. Methods This multicenter observational case series included 37 adults with Artemisia -driven SAR uncontrolled by standard therapy between August and December 2025. Patients received Stapokibart 600 mg at baseline, followed by 300 mg at week 2. Clinical outcomes, including Total Nasal Symptom Score (TNSS), VAS-Nose, VAS-Ophthalmic, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Medication Score, were assessed at baseline and weeks 1, 2, 4, 6, 12, and 16. Peripheral eosinophils, total IgE, and fractional nasal Nitric Oxide at a flow rate of 10 mL/(FnNO10) were measured at baseline, week 4, and week 16. Safety was monitored throughout follow-up. Results Stapokibart produced rapid and sustained symptom improvement. TNSS decreased from 9.22 ± 1.11 at baseline to 2.87 ± 1.32 at week 1 and 0.97 ± 0.83 at week 4, remaining low through week 16 (0.19 ± 0.40). Similar improvements were observed in VAS and RQLQ scores, accompanied by a marked reduction in medication use. FnNO10 decreased significantly by week 4 and remained suppressed at week 16, whereas total IgE showed no significant change. No serious adverse events occurred. Conclusions A two-dose, season-oriented Stapokibart regimen achieved rapid and durable symptom control with favorable safety in real-world SAR. This pragmatic strategy may represent a practical biologic approach aligned with seasonal disease dynamics.

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Publication Details

Journal
World Allergy Organization Journal
Published
2026-08-13
DOI
https://doi.org/10.1016/j.waojou.2026.101447
Primary Topic
Allergic Rhinitis and Sensitization
Type
article
Field-Weighted Citation Impact
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article

A short-course and season-oriented Stapokibart strategy for moderate-to-severe seasonal allergic rhinitis: Real-world evidence from Northern China

Lili Zhi, 原 廣美, H Li, Na Zhang et al.
World Allergy Organization Journal
Allergic Rhinitis and Sensitization
article

A short-course and season-oriented Stapokibart strategy for moderate-to-severe seasonal allergic rhinitis: Real-world evidence from Northern China

Lili Zhi, 原 廣美, H Li, Na Zhang, Jingjing Wang, Yunqing Zhang, Ling Zhou, Mengwei Wu, Xu Li, Tingting Gao, He Geng, Yan Sun, Chao Wang, Peng Jin, Na Liu, Peize Liu
article en

Abstract

Background Seasonal allergic rhinitis (SAR) imposes a substantial disease burden worldwide. In Northern China, Artemisia pollen is the dominant autumn allergen, and many patients with moderate-to-severe SAR remain inadequately controlled despite intranasal corticosteroids and antihistamines. Stapokibart, an IL-4Rα–blocking monoclonal antibody, has shown efficacy in randomized trials, but real-world evidence and season-oriented treatment strategies remain limited. We evaluated the effectiveness and safety of Stapokibart and explored the feasibility of a short-course, season-oriented biologic strategy in SAR. Methods This multicenter observational case series included 37 adults with Artemisia -driven SAR uncontrolled by standard therapy between August and December 2025. Patients received Stapokibart 600 mg at baseline, followed by 300 mg at week 2. Clinical outcomes, including Total Nasal Symptom Score (TNSS), VAS-Nose, VAS-Ophthalmic, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Medication Score, were assessed at baseline and weeks 1, 2, 4, 6, 12, and 16. Peripheral eosinophils, total IgE, and fractional nasal Nitric Oxide at a flow rate of 10 mL/(FnNO10) were measured at baseline, week 4, and week 16. Safety was monitored throughout follow-up. Results Stapokibart produced rapid and sustained symptom improvement. TNSS decreased from 9.22 ± 1.11 at baseline to 2.87 ± 1.32 at week 1 and 0.97 ± 0.83 at week 4, remaining low through week 16 (0.19 ± 0.40). Similar improvements were observed in VAS and RQLQ scores, accompanied by a marked reduction in medication use. FnNO10 decreased significantly by week 4 and remained suppressed at week 16, whereas total IgE showed no significant change. No serious adverse events occurred. Conclusions A two-dose, season-oriented Stapokibart regimen achieved rapid and durable symptom control with favorable safety in real-world SAR. This pragmatic strategy may represent a practical biologic approach aligned with seasonal disease dynamics.

World Allergy Organization JournalVol. 19(9)
Second Hospital of Shandong University (CN), Shandong Provincial QianFoShan Hospital (CN), Qilu Hospital of Shandong University (CN), Shandong First Medical University (CN)
Openalex Percentile: Top 12%
Allergic Rhinitis and Sensitization
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