Abstract
PurposePatients with life-threatening asthma typically experience recurrent exacerbations, are dependent on oral corticosteroids (OCSs), and have considerable asthma-related health care costs. Data on the impact of mepolizumab on exacerbations and OCS use in patients with life-threatening asthma in real-world clinical practice are limited. This study assessed the impact of mepolizumab on exacerbation rates and OCS use in patients with life-threatening asthma in a real-word setting. MethodsThis retrospective study utilized data from US administrative claims from patients with life-threatening asthma. Eligible patients were treated between November 1, 2015, and December 31, 2017; were ≥12 years of age upon mepolizumab initiation (index date); and had undergone at least two mepolizumab administrations during the 6 months postindex. Data from the 12 months before (baseline) and after (follow-up) index were collected, with each patient serving as his or her own control. Life-threatening asthma was defined as at least three exacerbations and/or at least one asthma-related hospitalization during baseline, and/or a history of endotracheal intubation. Asthma exacerbation frequency and OCS use were assessed. FindingsThe analysis included 327 patients who received a mean (SD) of 10.6 (4.3) mepolizumab doses during follow-up. The percentage of patients experiencing at least one exacerbation and the mean exacerbation rate were significantly reduced from baseline to follow-up with mepolizumab, from 94.5% to 67.9% (P < 0.001), and from 3.2 to 1.5 events per patient per year, corresponding to a 53.1% relative reduction (P < 0.001). The percentage of patients with OCS claims was reduced by 12.6%, from 99.1% to 86.5% (P < 0.001). Of the patients who had a reduction in mean daily OCS use, most (57.9%, 140/242) had a reduction in mean daily OCS use of at least 50%. ImplicationsThese data from patients with life-threatening asthma in clinical practice demonstrated that asthma exacerbation and OCS use were significantly reduced with mepolizumab treatment.
Highlights
Severe asthma is a heterogeneous respiratory disease with several clinically recognized phenotypes, including severe eosinophilic asthma.[1]
Some patients with severe asthma require long-term use of a high-dose inhaled corticosteroid (ICS) and/or a systemic corticosteroid (SCS);[1,9] SCS use has been associated with cardiovascular, gastrointestinal, bone, ocular, and metabolic complications.[6,10,11,12,13]
The use of most asthma medications was reduced during follow-up, with statistical significance reached with a short-acting β2-agonist alone or in combination with a shortacting muscarinic antagonist (P < 0.001), a short
Summary
Severe asthma is a heterogeneous respiratory disease with several clinically recognized phenotypes, including severe eosinophilic asthma.[1]. Mepolizumab is a humanized anti-interleukin (IL)[5] monoclonal antibody that binds to and inactivates IL-5, thereby blocking eosinophilic inflammation.[14] Its use as an add-on therapy for patients with severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, or hypereosinophilic syndrome has been approved.[15] The use of mepolizumab has been associated with reduced rates of exacerbation, exacerbationrelated hospitalization, and oral corticosteroid (OCS) use in patients with severe eosinophilic asthma in placebo-controlled clinical trials.[16,17,18] In patients with the most severe form, life-threatening asthma, reductions in exacerbation rate and daily OCS use were observed in the Phase IIIb open-label mepolizumab extension study COSMEX (A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects; ClinicalTrials.gov identifier: NCT02135692).[19] In that study, the definition of lifethreatening asthma included a history of intubation, hospitalization for asthma exacerbation, and recurrent exacerbations (more than three within a 12-month period). These study criteria indicate an unmet need for data on the effectiveness of mepolizumab in patients with life-threatening asthma in clinical practice
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