Although approved for use among patients with severe or refractory asthma, few studies have investigated its effectiveness among patients with comorbid mild to moderate asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
A new study that used the forced oscillation technique (FOT) to evaluate the effectiveness of dupilumab among patients with comorbid mild to moderate asthma already taking the IgG4 monoclonal antibody to treat their chronic rhinosinusitis with nasal polyps (CRSwNP) found potential improvements in respiratory functions, asthma symptoms, and asthma severity.
Findings were published recently in BMC Pulmonary Medicine, and they also apply to patients with nonsevere cases of bronchial asthma.“Since dupilumab is approved only for severe or poorly controlled asthma,” the authors wrote, “no previous reports have analyzed the efficacy of dupilumab exclusively in patients with mild to moderate asthma, especially in real-life settings.”
They carried out their retrospective analysis among 62 consecutive patients receiving care for their CRSwNP, including treatment with dupilumab, between May 2020 and July 2021 at the Department of Otolaryngology and Respiratory Medicine in Matsuwaki Clinic Shinagawa, in Japan. Treatment consisted of 300 mg subcutaneous dupilumab administered every 2 weeks, a visual analogue scale (VAS) evaluated CRSwNP symptom severity, Global Initiative of Asthma (GINA) guidance were used to dictate treatment steps and severity assessment, and participants were evaluated at baseline and 3 and 12 months following dupilumab administration.
Most of the patients (n = 50) had mild/moderate asthma, and of this group, 23 underwent testing at the 3- and 12-month marks. None of the patients with severe asthma (n = 12) underwent 12-month testing. Dupilumab was the most common first-line treatment (93.5%) for asthma in the 3 months leading up to the baseline visit.
Nitric oxide concentration (FeNO) dropped significantly after 3 months of dupilumab use and this effect was maintained at the 1-year mark, although the rate of decrease had slowed. Blood eosinophil counts increased steadily from baseline to 12 months, but immunoglobulin E (IgE) levels dropped between the 3- and 12-month marks (after increasing slightly from baseline to 3 months.
Asthma Control Test (ACT) scores (on a scale of 5 [poor control] to 25 [complete control]) showed steady improvement from baseline to 1 year, and the authors deemed this change significant, with baseline scores of approximately 23 increasing to just over 24 by 1 year. This finding was reflected in the steady GINA-directed treatment downgrading seen throughout the study period.
Specifically regarding CRSwNP, by 3 months, significant improvements were seen in nasal polyp score, CT grade, and odor score following dupilumab initiation, and this improvement proved steady through 12 months. In particular, few patients were still receiving steroid treatment at the 12-month mark, and this was subsequent to significant reductions in prednisone use already seen at 3 months.
Respiratory function improvements were seen in forced expiratory volume in 1 s (FEV1), percentage of predicted FEV1, the percentage of predicted forced vital capacity (%FVC), and the FEV1/FVC ratio (%FEV1) by 3 months, and these results were maintained at the 1-year mark. Dupilumab was also shown to improve respiratory impedance by 3 months; changes in respiratory resistance were deemed not significant.
A subanalysis of dupilumab effectiveness between the patients with mild/moderate and severe asthma showed the treatment’s administration benefited both groups with regard to FEV1, %FEV1, and %FVC. In addition, patients with CRSwNP in both groups were able to significantly decrease their oral corticosteroid use (prednisone) after 3 months of dupilumab use, although the decrease was significantly greater among those with mild/moderate vs severe asthma.
Another subanalysis considered %FEV improvement below and above 3.8 L for 9 factors (aspirin exacerbated respiratory disease, FeNO, IgE, blood eosinophil count, ACT score, treatment step via GINA, preoperative eosinophil count in nasal polyps, sinusitis CT score, and VAS) associated with asthma and CRSwNP. Significant differences were seen in predose FeNO and IgE, “suggesting that the higher values of FeNO and IgE can be associated with more improved respiratory functions by dupilumab treatment,” the authors wrote.
“The present study showed that dupilumab significantly improved respiratory functions (FEV1, %FEV1, %FVC) in patients with clinically controlled mild to moderate asthma associated with CRSwNP at 3 months of the administration,” the authors concluded. “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.”
Despite their findings, the authors suggest their results be investigated over a longer follow-up period among patients with comorbid CRSwNP and mild/moderate asthma.
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