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Study Shows Dupilumab May Help Ear Disease in Nasal Polyp Patients
Confirmed
In Short: Investigators found that dupilumab, a biologic medication aimed at type 2 inflammation, showed positive effects on middle ear disease in patients with eosinophilic otitis media (EOM) and severe chronic rhinosinusitis with nasal polyps (CRSwNP).
The study, which involved 48 adults with severe CRSwNP and concomitant EOM treated at four tertiary otorhinolaryngology centers in Sicily, Italy, aimed to address the gap in understanding the impact of dupilumab on otologic outcomes.
Lead author Cosimo Galletti, MD, reported that over 12 months, the agent improved both sinonasal and otologic outcomes, including a significant drop in disease activity and a favorable safety profile.
Dupilumab is not approved for any ear-specific diagnosis, so prescribing rests on the CRSwNP indication. However, the study adds to the emerging body of evidence that anti-Th2 biologics help with eosinophilic middle ear disease.
Patients received dupilumab 300 mg every 2 weeks, with outcomes evaluated at baseline, 6 months, and 12 months. At baseline tympanometry, 32 patients had type B patterns and 16 had type C patterns; by 12 months, 36 patients had type A tympanograms and 12 had type C tympanograms.
Schuman said he would be “very quick to start a biologic like dupilumab” in a patient with severe asthma and difficult-to-control CRSwNP who also had refractory middle ear disease. He would be more likely to stick to conventional treatments for patients with EOM lacking significant inflammatory airway disease.
What this adds
The study provides new evidence on the potential benefits of dupilumab for middle ear disease, but further clinical trials are needed to confirm its efficacy and compare it to other treatments.
What's confirmed
- The study, which involved 48 adults with severe CRSwNP and concomitant EOM treated at four tertiary otorhinolaryngology centers in Sicily, Italy, aimed to address the gap in understanding the impact of dupilumab on otologic outcomes.
- Lead author Cosimo Galletti, MD, reported that over 12 months, the agent improved both sinonasal and otologic outcomes, including a significant drop in disease activity and a favorable safety profile.
- Dupilumab is not approved for any ear-specific diagnosis, so prescribing rests on the CRSwNP indication. However, the study adds to the emerging body of evidence that anti-Th2 biologics help with eosinophilic middle ear disease.
- Patients received dupilumab 300 mg every 2 weeks, with outcomes evaluated at baseline, 6 months, and 12 months. At baseline tympanometry, 32 patients had type B patterns and 16 had type C patterns; by 12 months, 36 patients had type A tympanograms and 12 had type C tympanograms.
- Schuman said he would be “very quick to start a biologic like dupilumab” in a patient with severe asthma and difficult-to-control CRSwNP who also had refractory middle ear disease. He would be more likely to stick to conventional treatments for patients with EOM lacking significant inflammatory airway disease.
What's still developing
- Dupilumab may offer relief for patients with eosinophilic otitis media (EOM) and severe chronic rhinosinusitis with nasal polyps (CRSwNP), according to investigators.
- Dupilumab has previously shown efficacy for severe CRSwNP in both randomized trials and real-world populations, according to the investigators, so sinonasal improvements are expected in suitable patients.
- “The more novel clinical question is whether dupilumab also improves EOM-related outcomes,” the investigators wrote.
- Patel noted that most patients with underlying sinonasal disease “can do very well with thorough, complete sinus surgery followed by topical steroid therapy, and never need to progress to using biologics,” she said, adding that “all major societies that treat upper airway inflammation” are aligned on that strategy.
- About 10%-15% of patients are not well controlled after that two-step process, she said, and those are the ones who stand to benefit from dupilumab or another biologic.
- “A major reason why some allergists and primary care doctors opt to start patients on biologics first, despite the need for lifelong use and the exceedingly high cost, is that they have seen patients who underwent surgery that was not thorough and complete, and these patients have failed to resolve,” Patel said.
- "Approaches that target plasmacytoid dendritic cells seem to work in cutaneous lupus erythematosus, and the safety outcomes have been excellent," study first author Victoria Werth, MD, professor of dermatology and rheumatology at the University of Pennsylvania, Philadelphia, told Medscape Medical News.
- The multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled 72 patients aged 18-75 years with moderate-to-severe, treatment-refractory DLE for ≥ 6 months with active disease — defined as a Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score of ≥ 8, without systemic features at baseline.
- Patients were randomized to receive low-dose daxdilimab (n= 24), high-dose daxdilimab (n = 23), or placebo (n = 25) for 24 weeks, administered every 4 weeks from day 1 through week 20.
- Another secondary endpoint was the proportion of patients who achieved a score of 0 or 1 on the Cutaneous Lupus Activity Investigator's Global Assessment at week 24: 60.3% of those on the low dose ( P <.0001) and 51.6% of those on the high dose ( P =.0007) met this endpoint, vs 8.9% of those on placebo.
- The study was published in the American Journal of Rhinology & Allergy.
- “We have many studies demonstrating that controlling inflammation in the sinonasal tract can help bring down inflammation within the middle ear space,” said Patel, who was not involved in the study.