NEW ORLEANS — Dupilumab significantly reduced severe asthma exacerbations in patients with oral corticosteroid-dependent severe asthma with and without early improvements in lung function, according to study data presented at the CHEST 2019 Annual Meeting held October 19 to 23, in New Orleans, Louisiana.
Researchers evaluated the efficacy of dupilumab in reducing severe asthma exacerbation rates in patients from the phase 3 LIBERTY ASTHMA VENTURE study (ClinicalTrials.gov Identifier: NCT02528214) whose asthma was stratified by clinically meaningful improvements of ≥100 mL or ≥200 mL in prebronchodilator forced expiratory volume in 1 second (FEV1) at week 12. A negative binomial regression model was used to analyze the annualized severe exacerbation rate following 24 weeks of treatment.
Study results demonstrated that a significantly greater number of patients in the dupilumab group (65.7%) achieved improvements in prebronchodilator FEV1 of ≥100 mL compared with patients in the placebo group (33.3%) at week 12 (P <.0001). Similarly, more patients achieved improvements in prebronchodilator FEV1 of ≥200 mL in the dupilumab group vs the placebo group (49.5% vs 23.8%, respectively; P =.0002).
Among patients who experienced improvements of ≥100 mL or ≥200 mL in prebronchodilator FEV1, researchers found that dupilumab significantly reduced severe exacerbations by 72% (P <.0001) and 71.9% (P =.0003), respectively, compared to placebo, during the 24-week treatment period. In patients with <100 mL and <200 mL prebronchodilator FEV1 improvements, dupilumab reduced severe exacerbations by 44.8% (P =0.08) and 57.1% (P =.006), respectively, compared to placebo.
Dupilumab was found to be generally well tolerated, with transient eosinophilia as the most common treatment-emergent adverse event. Injection site reactions occurred more frequently in patients who received dupilumab (9%) compared with those who received placebo (4%).
Dupilumab is a fully human monoclonal antibody that inhibits interleukin-4. It is currently indicated as add-on maintenance treatment in patients with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Other indications include treatment for moderate to severe atopic dermatitis and for chronic rhinosinusitis with nasal polyposis.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Hanania N, Castro M, Mirapeix C, et al. Dupilumab reduces severe exacerbations in patients with oral corticosteroid-dependent severe asthma with and without early improvements in lung function. Presented at: CHEST Annual Meeting 2019; October 19-23, 2019; New Orleans, LA. Abstract 929.