Real-world mepolizumab in the prospective severe asthma REALITI-A study – initial analysis
- Tim Harrison1,
- Giorgio Walter Canonica2,
- Geoffrey Chupp3,
- Jason Lee4,
- Florence Schleich5,
- Tobias Welte6,
- Antonio Valero7,
- Kim Gemzoe8,
- Aoife Maxwell9,
- Sandra Joksaite10,
- Shibing Yang11,
- Peter Howarth12 and
- Melissa K. Van Dyke13⇑
- 1Nottingham NIHR Biomedical Research Centre, Nottingham City Hospital, University of Nottingham, Nottingham, UK
- 2Personalized Medicine Asthma and Allergy Clinic, Department of Biomedical Sciences, Humanitas University & Research Hospital, Milan, Italy
- 3Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
- 4Toronto Allergy and Asthma Clinic, Toronto, ON, Canada
- 5Department of Pulmonary Medicine, CHU Sart-Tilman and GIGA I3 Research Group, University of Liège, Liège, Belgium
- 6Department of Respiratory Medicine and German Center for Lung Research, Hannover Medical School, Hannover, Germany
- 7Sección de Alergología, Servicio de Neumología y Alergia, Hospital Clínic de Barcelona, Universitat de Barcelona, IDIBAPS, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain
- 8Real World Study Delivery, Value Evidence and Outcomes, Global Medical, GSK, Stockley Park, Uxbridge, Middlesex, UK
- 9Real World Study Delivery, Value Evidence and Outcomes, Global Medical, GSK, Stevenage, Hertfordshire, UK
- 10Clinical Statistics, R&D Projects Clinical Platforms and Sciences, GSK, Stockley Park West, Uxbridge, Middlesex, UK
- 11Value Evidence & Outcomes, GSK, Collegeville, PA, USA
- 12Global Medical Franchise, GSK House, Brentford, Middlesex, UK
- 13Epidemiology, GSK, Upper Providence, PA, USA
- Dr Melissa Van Dyke, 1250 S. Collegeville Rd, Collegeville, PA 19426, USA. E-mail: melissa.k.van-dyke{at}gsk.com
Abstract
Background Efficacy of mepolizumab, an anti-interleukin-5 monoclonal antibody, was demonstrated in randomised, controlled trials; data on its real-world impact in routine clinical practice are starting to emerge. We assessed the effectiveness and safety of mepolizumab prescribed for patients in the real world.
Methods REALITI-A is a global, prospective, observational cohort study, collecting data from routine healthcare visits from patients with asthma. Patients newly prescribed mepolizumab for severe asthma with 12 months' relevant medical history pre-mepolizumab (collected retrospectively) were enrolled. An initial analysis of data from early initiators who had completed 1-year follow-up (as of 28 February 2019) was conducted. The primary objective was to compare the rate of clinically significant exacerbations (CSEs; requiring oral corticosteroids [OCS] and/or hospitalisation/emergency department [ED] visit) before and after mepolizumab; exacerbations requiring hospitalisation/ED visit and change in maintenance OCS use were secondary objectives. Treatment-related adverse events (AEs) were reported.
Results Overall, 368 mepolizumab-treated patients were included. Rates of CSEs were reduced by 69% from 4.63/person/year pre-treatment to 1.43/person/year during follow-up (p<0.001), as were those requiring hospitalisation and/or ED visits (from 1.14/person/year to 0.27/person/year; 77% reduction). In 159 patients with maintenance OCS dose data available during the pre-treatment period, median daily dose decreased from 10.0 mg·day−1 (pre-treatment) to 5.0 mg·day−1 by Week 21–24 of follow-up, sustained until Week 53–56. No new safety signals were reported.
Conclusion These data demonstrate that the effectiveness of mepolizumab is consistent with clinical trial results under real-world settings, with significant reductions in exacerbations and daily maintenance OCS dose.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Harrison reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GSK, personal fees from Vectura, personal fees from AstraZeneca, outside the submitted work.
Conflict of interest: Dr. Canonica reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GSK, personal fees from AstraZeneca, personal fees from Sanofi-Genzyme, personal fees from Regeneron, personal fees from Novartis, outside the submitted work.
Conflict of interest: Dr. Chupp reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GSK, personal fees from AstraZeneca, personal fees from Genentech, personal fees from Sanofi Genzyme, personal fees from Regeneron, personal fees from Teva, personal fees from Novartis, outside the submitted work.
Conflict of interest: Dr. Lee reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; grants from Regeneron, grants and personal fees from GSK, grants and personal fees from Sanofi-Genzyme, grants from Novartis, grants and personal fees from AstraZeneca, grants from Genentech, grants from Roche, grants from Takeda, grants from Medexus, personal fees from Mylan, personal fees from Medexus, personal fees from Aralez, personal fees from Merck, outside the submitted work.
Conflict of interest: Dr. Schleich reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; grants and personal fees from AstraZeneca, grants, personal fees and non-financial support from Chiesi, personal fees from Menarini, personal fees from Mundipharma, grants, personal fees and non-financial support from Novartis, grants and personal fees from GSK, outside the submitted work.
Conflict of interest: Dr. Welte reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; grants and personal fees from AstraZeneca, personal fees from Novartis,, personal fees from Sanofi, personal fees from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Valero reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from AstraZeneca, personal fees from Novartis, personal fees from Sanofi, personal fees from Boehringer, personal fees from Mundipharma, personal fees from Chiesi, personal fees from GSK, outside the submitted work.
Conflict of interest: Dr. Gemzoe reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Maxwell reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Joksaite reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Yang reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Howarth reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
Conflict of interest: Dr. Van Dyke reports other from GlaxoSmithKline, non-financial support from GlaxoSmithKline, during the conduct of the study; personal fees from GlaxoSmithKline, other from GlaxoSmithKline, outside the submitted work.
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- Received January 23, 2020.
- Accepted July 23, 2020.
- Copyright ©ERS 2020