In patients with eosinophilic sinusitis that is comorbid with mild to moderate bronchial asthma, sinusitis treatment with dupilumab may improve pulmonary function and asthma symptoms and reduce asthma treatment, according to the results of a retrospective, observational study recently published in BMC Pulmonary Medicine.
Although the anti–interleukin (IL)-4α receptor antibody dupilumab is indicated for uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) and severe or uncontrolled bronchial asthma, it has not been a recommended treatment for well-controlled or mild to moderate asthma, said study researchers. The current study of patients with mild to moderate asthma and CRSwNP sought to determine how dupilumab treatment initiated for CRSwNP affected the patient’s mild to moderate asthma, particularly with respect to changes in type 2 inflammatory markers, Asthma Control Test (ACT) scores, pulmonary function tests, and forced oscillation technique.
All study participants were examined at a single center in Japan — the Department of Otolaryngology and Respiratory Medicine in Matsuwaki Clinic Shinagawa in Tokyo. A total of 62 consecutive adult patients underwent respiratory, otolaryngologic, and blood examinations after 3 months of dupilumab therapy for sinusitis, with 23 individuals undergoing tests after 1 year of treatment. Most of the patients studied had been treated with an approximate 5-mg daily dose of oral corticosteroids (prednisone) for poorly controlled sinusitis. All study participants had a history of asthma or were currently receiving treatment for asthma; none had experienced asthma attacks during the past 3 months and all were well controlled with their current asthma treatment (mean ACT score, 22 to 23) or were treatment-free.
In investigating changes in type 2 inflammatory markers in patients with mild to moderate asthma, the researchers found that fractional exhaled nitric oxide concentration (FENO) decreased significantly 3 months after dupilumab therapy for sinusitis (P <.01 by student’s test), with these reductions maintained at 1 year. Peripheral blood eosinophil counts demonstrated slight elevations without any significance until 1 year. ACT scores prior to dupilumab therapy for sinusitis were generally good (mean score, 22.9). At 3 months after dupilumab treatment for sinusitis, statistically significant improved ACT scores were reported (P <.05), which were maintained for 1 year.
Further, with respect to CRSwNP assessments, treatment with dupilumab significantly improved the nasal polyp score, computed tomography (CT) grade, and odor score at 3 months (P <.01 by t-test for all), which all were further improved after 1 year. Additionally, corticosteroid use in patients with CRSwNP was reduced significantly at 3 months (P <.01 by t-test), which was further improved after 1 year of treatment.
In terms of respiratory function, forced expiratory volume in 1 second (FEV1), percentage of predicted forced expiratory volume in 1 second (%FEV1), percentage of predicted forced vital capacity (%FVC), and FEV1/FVC ratio (FEV1%) were all measured with the use of spirometry. The pre-dupilumab values of FEV1, %FEV1, and %FVC all improved significantly at 3 months, with the improvement maintained for 1 year. FEV1%, however, did not change significantly with dupilumab therapy.
Limitations of the current study include the fact that because of its retrospective, observational design, a comparison with a placebo control could not be conducted. Further, although the study assessed 50 individuals mainly for treatment effectiveness over 3 months, 23 patients were still evaluated for testing after 1 year.
The researchers concluded that “dupilumab therapy not only has a marked effect on CRSwNP but may also improve respiratory functions and symptoms and reduce the dose of asthma treatment, even if comorbid asthma is not severe and is clinically controlled.”
Minagawa S, Araya J, Watanabe N, et al. Real-life effectiveness of dupilumab in patients with mild to moderate bronchial asthma comorbid with CRSwNP. BMC Pulm Med. Published online June 28, 2022. doi:10.1186/s12890-022-02046-3