Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study

摘要: Abstract Purpose Patients with severe eosinophilic asthma often experience recurrent exacerbations despite intensive inhaled corticosteroid therapy. In 2 previous double-blind studies (MENSA [NCT01691521] and SIRIUS [NCT01691508]), treatment intravenous or subcutaneous mepolizumab was associated significantly reduced annualized exacerbation rates oral (OCS) requirements compared placebo. The purpose of this study to assess the long-term safety efficacy in patients asthma. Methods COSMOS a 52-week, open-label extension who received placebo MENSA SIRIUS. regardless prior allocation continued receive appropriate standard-of-care therapy throughout. primary objective mepolizumab; end points included adverse events (AEs) serious AEs (SAEs). Efficacy assessments rate durability response (defined as OCS dose reduction when combined data, respectively). Findings total, 558 (86%; mepolizumab: 358; placebo: 200) 94 (14%; 58, 36) experienced on-treatment SAEs, respectively. No fatal were reported. Totals 13 (2%) 29 (4%) systemic local site reactions, There no reports mepolizumab-related anaphylaxis. Mepolizumab shown exert durable response, previously maintaining reductions dosing throughout COSMOS. demonstrated improvements these following Implications These data demonstrate favorable profile indicate stable effect over time, supporting ClinicalTrials.gov identifier: NCT01842607.