Cosimo Galletti, Giovanna Stilo, Federico Sireci, Federica Giammona Indaco, Daniele Portelli, Maria Antonietta Barbieri, Silvia Frangipane, Giorgia Giunta, Riccardo Manzella, Maria Grazia Ferrisi, Angelo Immordino, Salvatore Maira, Antonino Maniaci, Francesco Ciodaro, Francesco Dispenza, Salvatore Cocuzza, Francesco Galletti, Salvatore Gallina, Ignazio La Mantia, Bruno Galletti
BackgroundEosinophilic otitis media (EOM) is a refractory type 2 inflammatory disease of the middle ear, frequently associated with asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Conventional otologic treatments often provide incomplete or transient benefit. Because EOM and CRSwNP may share a type 2 inflammatory pathway involving the nasal, Eustachian tube, and middle-ear compartments, biologic therapy may offer benefit beyond sinonasal disease control. Long-term multicenter real-world data on dupilumab in patients with concomitant EOM and severe CRSwNP remain limited.ObjectiveTo evaluate the 12-month effectiveness of dupilumab on subjective and objective otologic outcomes in adults with EOM and severe CRSwNP.MethodsIn this multicenter observational cohort, 48 adults with severe CRSwNP and concomitant EOM, diagnosed according to Iino criteria, received dupilumab 300 mg every 2 weeks. Otologic outcomes included the Chronic Otitis Media Outcome Test 15 (COMOT-15; range 0-75) and tympanometry. Sinonasal outcomes, including Nasal Polyp Score, SNOT-22, and visual analog scale of nasal congestion, were secondary measures. Outcomes were evaluated at baseline, 6 months, and 12 months.ResultsDupilumab was associated with progressive improvement in EOM-related outcomes. Median COMOT-15 decreased from 49 at baseline to 20 at 6 months and 15 at 12 months (P < 0.0001). Tympanometry improved from 32 type B and 16 type C patterns at baseline to predominantly type A patterns at 12 months. Sinonasal outcomes also improved: median NPS decreased from 6 to 3 and 2, SNOT-22 from 68 to 28 and 22, and VAS nasal congestion from 8 to 2 and 1 at 6 and 12 months, respectively (all P < 0.0001). Peripheral eosinophil counts did not significantly decrease.ConclusionIn patients with severe CRSwNP and concomitant EOM, dupilumab was associated with sustained 12-month improvement in EOM-related quality of life and tympanometric patterns, supporting further investigation within a one-airway-one-ear type 2 framework.