[en] BACKGROUND: Although clinical trial evidence exists, there is limited awareness of the real-world effectiveness of mepolizumab in patients with severe asthma and blood eosinophil counts (BEC) ≥150-<300 cells·μL(-1). METHODS: REALITI-A, an international, prospective, single-arm, observational cohort study enrolled patients with severe asthma initiating mepolizumab. Outcomes assessed over 2 years pre- versus post-mepolizumab exposure included clinically significant exacerbations (CSEs), maintenance oral corticosteroid (mOCS) use, Asthma Control Questionnaire (ACQ)-5 scores and forced expiratory volume in 1 s (FEV(1)). RESULTS: After 2 years of mepolizumab treatment, compared with pre-exposure, the proportion of patients with BEC ≥150-<300 cells·μL(-1) (n=84) experiencing CSEs decreased from 95% to 63%, and the proportion experiencing exacerbations requiring hospitalisation or emergency department visits decreased from 43% to 19%. The rate of CSEs reduced from 4.53 to 1.47 per year (rate ratio 0.32, 95% CI 0.25, 0.41). After 2 years of mepolizumab exposure, the mean (95% CI) clinic pre-bronchodilator % predicted FEV(1) was 80.1 (69.4, 90.7) compared with 62.6 (54.1, 71.1) at baseline (28% relative increase). The median average daily dose of mOCS decreased from 10.0 to 1.5 mg·day(-1) (85% relative reduction from baseline); 44% of patients discontinued completely. The minimum clinically important difference in ACQ-5 (improvement ≥0.5) was achieved by 82% of patients, with a mean (95% CI) reduction of 1.76 (2.34, 1.19). CONCLUSIONS: These real-world findings provide evidence for the 2-year sustained benefit following initiation of mepolizumab in patients with severe asthma who have poor disease control and BEC ≥150-<300 cells·μL(-1).
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Canonica, Giorgio W ; Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center, IRCCS, Rozzano, Italy. ; Department of Biomedical Sciences, Humanitas University, Milan, Italy.
Bagnasco, Diego ; Allergy and Respiratory Diseases, IRCCS Policlinic San Martino, University of Genoa, Genoa, Italy.
Lee, Jason K; Toronto Allergists, Toronto, Canada. ; Evidence Based Medical Educator Inc., Toronto, Canada.
Chupp, Geoffrey; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Schleich, Florence ; Université de Liège - ULiège > Département des Sciences de l'activité physique et de la réadaptation > Physiologie humaine et physiologie de l'effort physique
Oppenheimer, John J; UMDNJ, Rutgers University School of Medicine, Newark, NJ, USA.
Zhang, Lingjiao; Biostatistics, GSK, Collegeville, PA, USA.
Alfonso-Cristancho, Rafael; Global Real-World Evidence and Health Outcomes Research, GSK, Collegeville, PA, USA.
Howarth, Peter ; Global Medical Affairs, Specialty Medicine, GSK, London, UK.
Language :
English
Title :
Mepolizumab in patients with severe asthma and blood eosinophil counts between 150 and 300 cells per µL: benefits at two years.
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