Effect of mepolizumab in severe eosinophilic asthma according to omalizumab eligibility. (July 2019)

• Record Type: Journal Article
• Authors: Humbert, Marc; Albers, Frank C.; Bratton, Daniel J.; Yancey, Steven W.; Liu, Mark C.; Hozawa, Soichiro; Llanos, Jean-Pierre; Kwon, Namhee
• Is Part Of: Respiratory medicine. Volume 154(2019)
• Page Start: 69
• Page End: 75
• Publication Date: 2019-07
• Subjects: Asthma -- Asthma interventions -- Eosinophilic asthma -- Allergic asthma -- Atopic asthma -- Treatment; ACQ-5 Asthma Control Questionnaire-5 -- CI confidence interval -- ED emergency department -- EU European Union -- FeNO fractional exhaled nitric oxide -- FEV1 forced expiratory volume in 1 s -- HRQoL health-related quality of life -- ICS inhaled corticosteroids -- IgE immunoglobulin E -- IL interleukin -- ILC2 type 2 innate lymphoid cell -- IV intravenously -- OCS oral corticosteroids -- QoL quality of life -- OR odds ratio -- RAST radioallergosorbent -- SC subcutaneous -- SGRQ St George's Respiratory Questionnaire -- Th2 type 2 T helper -- US United States; Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2019.06.004
• Languages: English
• ISSNs: 0954-6111

Abstract

Abstract: Background: Patients with severe asthma can present with overlapping eosinophilic and allergic phenotypes, which makes it challenging when deciding which biologic therapy is most appropriate to reduce exacerbations and help achieve asthma control. Objective: This post hoc meta-analysis evaluated the efficacy of the licensed dose of mepolizumab (100 mg administered subcutaneously [SC]) versus placebo in patients with severe eosinophilic asthma (SEA), according to omalizumab eligibility and associated allergic characteristics. Methods: Data from two Phase 3 studies (MENSA [MEA115588/NCT01691521]; MUSCA [200862/NCT02281318]) were analyzed. Patients ≥12 years of age with SEA who experienced ≥2 exacerbations in the previous year received placebo, mepolizumab 100 mg SC or 75 mg intravenously, plus standard of care (high-dose inhaled corticosteroids and other controllers), every 4 weeks. Data from patients who received ≥1 dose placebo or mepolizumab 100 mg SC were used for this analysis. The primary endpoint was the rate of clinically significant exacerbations; other outcomes included forced expiratory volume in 1 s (FEV1 ), Asthma Control Questionnaire (ACQ-5) score and quality of life measured using St George's Respiratory Questionnaire (SGRQ). Results: Rate reductions in clinically significant exacerbations with mepolizumab versus placebo were similar in omalizumab eligible and ineligible patients (57% vs 55%). FEV1, ACQ-5 and SGRQ scores improved with mepolizumab versus placebo regardless of omalizumab eligibility, Immunoglobulin E levels, or atopic status. Conclusion: This analysis indicated that mepolizumab 100 mg SC has clinical benefit in patients with blood eosinophil counts ≥150 cells/μL (or history of ≥300 cells/μL), regardless of allergic characteristics or omalizumab eligibility. Highlights: Mepolizumab has clinical benefit regardless of atopic status/omalizumab eligibility. In omalizumab-eligible and ineligible patients exacerbations decreased similarly. FEV1, ACQ-5 and SGRQ scores improved irrespective of omalizumab eligibility.