Abstract
Purpose:
To present a rare, to our knowledge previously undescribed, case of successful AFRS management using stapokibart (CM310).
Patients and methods:
The laboratory, immunological, symptom scores and imaging datas before and after stapokibart treatment were evaluated to determine the effect of stapokibart on AFRS.
Results:
After four weeks of treatment, the patient showed significant clinical improvement, including a marked reduction in nasal polyp size and the near-complete return of normal olfaction. By week 16, lab tests confirmed a substantial drop in eosinophils and IgE, and a follow-up CT scan showed complete resolution of sinus inflammation. The patient reported high satisfaction due to a major improvement in quality of life.
Conclusion:
This pioneering case demonstrates that stapokibart, a novel anti-IL-4Rα antibody, is a promising and effective treatment for refractory AFRS, showing a rapid onset of action and sustained control of type 2 inflammation.
Introduction
Allergic fungal rhinosinusitis (AFRS) typically presents at a younger age with more severe clinical manifestations, a higher recurrence rate, a pronounced impairment of olfactory function (1), and a strong association with environmental atopy. In light of the significant surgical burden and recurrence patterns, current research is evaluating biologics as a potential breakthrough in medical therapy (2). However, AFRS remains underrepresented in current research, highlighting a notable gap in focused investigation. In this letter, we present a rare, to our knowledge previously undescribed, case of successful AFRS management using stapokibart (CM310).
Case report
We present the case of a 33-year-old male diagnosed with AFRS, who experienced recurrence of symptoms two months after undergoing endoscopic sinus surgery. Following recurrence, he was managed with intranasal corticosteroids but with inadequate response. He reported persistent nasal congestion, mucopurulent rhinorrhea, olfactory dysfunction, and headache, which significantly affected his daily life and work. Serum-specific IgE testing confirmed a high level of sensitization to a mold mix (3.7 KUA/L, Class 3—severe), which is pathognomonic for AFRS and consistent with the markedly elevated total IgE level of 399 KU/L observed at diagnosis. Nasal endoscopy revealed jelly-like secretions in the left middle meatus. Computed tomography demonstrated heterogeneous opacities (reflecting inspissated fungal mucin within hypodense mucosa), mucosal inflammation with sinus ostium obstruction, and bony remodeling evidenced by sinus expansion and focal erosions, the CT sinus scan was highly suggestive of AFRS. Histopathological examination revealed fungal elements, severe mixed inflammatory infiltrates, and abundant mucin deposition. Laboratory testing indicated an elevated eosinophil count of 0.65 × 109 /L (reference range: 0.02–0.52 × 109 /L) and a total IgE level of 399 KU/L (reference range: <60 KU/L).
Twelve months after the initial surgery, and following multidisciplinary evaluation, a therapeutic regimen was initiated, consisting of stapokibart 300 mg administered subcutaneously every two weeks in combination with intranasal corticosteroids. The treatment course lasted for 16 weeks, with routine monitoring of blood parameters, IgE levels, nasal endoscopy findings, and imaging outcomes.
Results
After one week of treatment, the patient reported alleviation of nasal obstruction and discharge. By the second week, olfactory function began to recover. At week four, nasal endoscopy demonstrated marked reduction in polyp size, and olfaction had largely returned to normal. Corresponding to these clinical improvements, symptom scores showed substantial reductions: the total nasal VAS score decreased from 8 to 3, SNOT-22 from 42 to 11, nasal congestion score from 3 to 1, and total symptom score from 8 to 2 (4 weeks). Laboratory markers exhibited a progressive decline, with eosinophil count dropping to 0.28 × 109 /L at week 4 and 0.21 × 109 /L at week 16; total IgE decreased from 399 to 195 KU/L by week 16. Correspondingly, testing for a mold mix showed a level of 0.75 KUA/L at follow-up, corresponding to Class 2 (moderate) sensitization. (Figure 1). Follow-up CT at week 16 showed complete resolution of the inflammatory opacities in the left maxillary sinus and improvement of the ethmoid sinus mucosa (Figure 2). Olfactory testing confirmed complete functional recovery, with accurate identification and naming of all odors previously unrecognized. The patient expressed a high degree of satisfaction with the treatment outcomes, particularly noting the significant improvement in olfactory function and nasal airflow, which translated into a substantial enhancement in quality of life. In this case, stapokibart was well-tolerated over the 16-week treatment period with no adverse events reported. This observation is consistent with the favorable safety profile reported in prior clinical trials of stapokibart for related type 2 inflammatory conditions (3). Provided are Pre- and Post-treatment nasal endoscopy images to visualize the progression (Figure 2).
Figure 1
Laboratory, immunological and symptom scores before and after the administration of stapokibart. Comparison of (A) SNOT-22, (B) total nasal VAS score, (C) NCS, (D) TSS, (E) SSIT, (F) Loss of smell VAS scores, (G) Blood eosinophil count and (H) serum IgE level pre and post stapokibart therapy. SNOT-22, sinonasal outcome test-22; VAS, visual analogue scale; NCS, nasal congestion score; TSS, total symptom score; SSIT, sino-nasal symptom interview test.
Figure 2
Imaging data of the case. (A–C) Comparison of endoscopic changes pre and post stapokibart therapy. (A1-A2) prior to treatment. (B1-B2) At 4-week follow-up after stapokibart therapy, endoscopic examination revealed complete resolution of the jam-like inspissated secretions in the left middle meatus. (C1-C2) 16 weeks after stapokibart therapy. (D) Pre-treatment CT scan of paranasal sinuses demonstrates unilateral, expansile lesions with heterogeneous opacities and noninvasive features. (E) 16 weeks after stapokibart therapy showed complete resolution of the inflammatory opacities in the left maxillary sinus and improvement of the ethmoid sinus mucosa.
Discussion
The immunologic profile of AFRS closely parallels that of other CRSwNP subtypes, indicating that biologic therapy may serve as a feasible adjunctive treatment following functional endoscopic sinus surgery. Although biologic agents such as dupilumab, omalizumab, and mepolizumab have been approved for the treatment of CRSwNP, patients with AFRS were not included in these clinical trials (4–6).
Stapokibart (CM310) is a novel humanized IgG4 monoclonal antibody that specifically targets the interleukin-4 receptor alpha (IL-4Rα), which inhibits IL-4 and IL-13 signaling which underlying eosinophilic inflammation (7). Type 2 inflammation plays a central role in the pathogenesis of AFRS. Consequently, biologic agents that selectively inhibit key mediators of type 2 immune responses represent a promising therapeutic strategy for patients with AFRS. In clinical studies, Zhang et al. demonstrated that stapokibart showed favorable safety and significant efficacy in treating severe eosinophilic chronic rhinosinusitis with nasal polyps and seasonal allergic rhinitis (3, 8). While established biologics for CRSwNP such as dupilumab and omalizumab have demonstrated significant improvements in olfactory function over longer timelines (e.g., at 24 weeks) (2, 9), the rapid recovery observed in this case may be attributed to the potent and early reduction of mucosal edema and inflammation in the olfactory cleft facilitated by dual IL-4/IL-13 pathway inhibition. This pioneering case highlights stapokibart's potential as a novel therapy for refractory AFRS. Effects of dupilumab receded upon discontinuation at 24 weeks, suggesting that continuation may be needed for sustained disease control (4). Unlike dupilumab, stapokibart interacts with M39, S95, and L135 and binds to IL-4Rα closer to the ligand binding site (10), suggesting distinct mechanisms and clinical outcomes. Notably, a marked reduction in peripheral eosinophil count and total serum IgE levels was observed, indicating effective suppression of the underlying immunologic drivers of AFRS.
Conclusion
These findings highlight the therapeutic potential and rapid onset of action of stapokibart in refractory AFRS, demonstrating symptomatic and pathological improvement. Optimal duration of stapokibart in AFRS patients is unknown. Further clinical trials are required to confirm efficacy. Critically, long-term monitoring is essential to assess durability, monitor for potential recurrence or contralateral spread, and identify predictive biomarkers. Future studies should also explore its role within comprehensive strategies that may include specific immunotherapy.
Statements
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
Ethics statement
The studies involving humans were approved by Ethical approval to report this case was obtained from the Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (UHCT-IEC-SOP-016-03-01). The studies were conducted in accordance with the local legislation and institutional requirements. Written informed consent for participation was not required from the participants or the participants’ legal guardians/next of kin in accordance with the national legislation and institutional requirements. Written informed consent was obtained from the individual(s) for the publication of any potentially identifiable images or data included in this article.
Author contributions
HC: Data curation, Funding acquisition, Writing – original draft, Conceptualization. X-JL: Writing – original draft, Investigation, Formal analysis. Y-QC: Writing – original draft, Resources, Methodology. S-ZL: Methodology, Writing – original draft, Investigation. J-JC: Writing – original draft, Resources, Investigation, Data curation. L-QZ: Data curation, Writing – review & editing, Conceptualization. TZ: Writing – review & editing, Methodology, Conceptualization, Resources.
Funding
The author(s) declared that financial support was received for this work and/or its publication. This work was financially supported by the National Natural Science Foundation of China (82201301, HC), the Natural Science Foundation of Hubei Province (2024AFB615, L-QZ).
Conflict of interest
The author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Generative AI statement
The author(s) declared that generative AI was not used in the creation of this manuscript.
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Summary
Keywords
allergic fungal rhinosinusitis, biological therapy, case report, chronic rhinosinusitis, stapokibart
Citation
Cai H, Luo X-J, Cao Y-Q, Li S-Z, Chen J-J, Zhou L-Q and Zhou T (2026) Successful use of stapokibart as a biological therapy for allergic fungal rhinosinusitis: a case report. Front. Allergy 6:1746033. doi: 10.3389/falgy.2025.1746033
Received
14 November 2025
Revised
30 December 2025
Accepted
30 December 2025
Published
14 January 2026
Volume
6 - 2025
Edited by
Cemal Cingi, Eskişehir Osmangazi University, Türkiye
Reviewed by
Hongtian Wang, Capital Medical University, China
Meryem Demir, Ege University, Türkiye
Updates
Copyright
© 2026 Cai, Luo, Cao, Li, Chen, Zhou and Zhou.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Jian-Jun Chen cjj131419@hust.edu.cn Liu-Qing Zhou 190042422@qq.com Tao Zhou entzt2013@sina.cn
†These authors have contributed equally to this work
Disclaimer
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.