2. Academic Validation
  3. Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis

Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis

  • Eur Respir J. 2020 Oct 15;56(4):2000151. doi: 10.1183/13993003.00151-2020.
Tim Harrison 1,  Giorgio Walter Canonica 2 3,  Geoffrey Chupp 4,  Jason Lee 5,  Florence Schleich 6,  Tobias Welte 7,  Antonio Valero 8,  Kim Gemzoe 9,  Aoife Maxwell 10,  Sandra Joksaite 11,  Shibing Yang 12,  Peter Howarth 13,  Melissa K Van Dyke 14
Affiliations

Affiliations

  • 1 Nottingham NIHR Biomedical Research Centre, Nottingham City Hospital, University of Nottingham, Nottingham, UK.
  • 2 Personalized Medicine Asthma and Allergy Clinic, Dept of Biomedical Sciences, Humanitas University and Research Hospital, Rozzano, Milan, Italy.
  • 3 Dept of Biomedical Science, Humanitas University, Pieve Emanuele, Milan, Italy.
  • 4 Division of Pulmonary, Critical Care, and Sleep Medicine, Dept of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
  • 5 Toronto Allergy and Asthma Clinic, Toronto, ON, Canada.
  • 6 Dept of Pulmonary Medicine, CHU Sart-Tilman and GIGA-I3 Research Group, University of Liège, Liège, Belgium.
  • 7 Dept of Respiratory Medicine and German Center for Lung Research, Hannover Medical School, Hannover, Germany.
  • 8 Sección de Alergología, Servicio de Neumología y Alergia, Hospital Clínic de Barcelona, Universitat de Barcelona, IDIBAPS, CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain.
  • 9 Real World Study Delivery, Value Evidence and Outcomes, Global Medical, GSK, Uxbridge, UK.
  • 10 Real World Study Delivery, Value Evidence and Outcomes, Global Medical, GSK, Stevenage, UK.
  • 11 Clinical Statistics, R&D Projects Clinical Platforms and Sciences, GSK, Uxbridge, UK.
  • 12 Value Evidence and Outcomes, GSK, Collegeville, PA, USA.
  • 13 Global Specialty & Primary Care, GSK, Brentford, UK.
  • 14 Epidemiology, GSK, Upper Providence, PA, USA.
PMID: 32817259 DOI: 10.1183/13993003.00151-2020
Abstract

Introduction: 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 of relevant medical history pre-mepolizumab (collected retrospectively) were enrolled. An initial analysis of data from early initiators who had completed 1 year of follow-up (as of February 28, 2019) was conducted. The primary objective was to compare the rate of clinically significant exacerbations (requiring oral corticosteroids (OCS) and/or hospitalisation and/or emergency department visit) before and after mepolizumab; exacerbations requiring hospitalisation and/or emergency department visit and change in maintenance OCS use were secondary objectives. Treatment-related adverse events were reported.

Results: Overall, 368 mepolizumab-treated patients were included. Rates of clinically significant exacerbations were reduced by 69% from 4.63 per person per year pre-treatment to 1.43 per person per year during follow-up (p<0.001), as were those requiring hospitalisation and/or emergency department visit (from 1.14 to 0.27 per person per year; 77% reduction). In 159 patients with maintenance OCS dose data available during the pre-treatment period, median daily dose decreased from 10.0 (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.

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