A Humanized Anti-IL-4Rα Monoclonal Antibody Improves the Sensation of Blockage in the Ear

Background: Otitis Media with Effusion (OME) is characterized by persistent middle ear effusion without acute infection. Type2 inflammation, mediated by IL-4 and IL-13 signaling through the IL-4Rα receptor, has been implicated in the pathogenesis of chronic rhinosinusitis with nasal polyps, asthma, and possibly OME. Refractory OME in adults remains a therapeutic challenge, as conventional treatments often fail to provide long-term resolution. Targeted biologic therapies that modulate type 2 inflammation may offer a novel therapeutic option. Methods: A 60-year-old man with a 15-year history of allergic rhinitis and chronic rhinosinusitis with nasal polyps, as well as multiple asthma exacerbations, presented with recurrent bilateral aural fullness, hearing loss, and tinnitus. His symptoms persisted despite repeated tympanic punctures, insufflation, and corticosteroid treatment. Otoscopic examination revealed dull tympanic membranes with effusion. Audiometry showed conductive hearing loss with a B-type tympanogram on the left and an A-type curve on the right. Laboratory evaluation demonstrated mildly elevated peripheral eosinophils. Results: The patient was diagnosed with OME, likely secondary to type 2 inflammation. Treatment with Stapokibart (CM310), a humanized anti–IL-4Rα monoclonal antibody, was initiated in March 2025. After nine biweekly injections, the patient experienced complete resolution of aural fullness. Otoscopy and tympanometry normalized, and audiometric thresholds improved significantly. No recurrence of ear symptoms was observed during follow-up. Conclusions: This case illustrates that IL-4Rα blockade with Stapokibart may be effective in refractory OME associated with type 2 inflammation. Early recognition of type 2–driven mechanisms in chronic middle ear disease could facilitate targeted therapy, offering symptom resolution and improved quality of life in patients unresponsive to conventional treatment.ral fullness; otitis media with effusion; allergic rhinitis.