Pneumologie 2020; 74(S 01): 25
DOI: 10.1055/s-0039-3403114
Posterbegehung (PO03) – Sektion Klinische Pneumologie
Neues zum Asthma bronchiale – Schwerpunkt schweres Asthma
Georg Thieme Verlag KG Stuttgart · New York

Effectiveness and safety of mepolizumab in real-world clinical practice: The REALITI-A study

T Harrison
1   Nottingham Nihr Biomedical Research Centre, Nottingham City Hospital, University of Nottingham, Nottingham, UK
,
G Canonica
2   Department of Biomedical Sciences, Humanitas University, Milan, Italy; Personalized Medicine, Asthma and Allergy Clinic, Humanitas Research Hospital, Milan, Italy
,
K Gemzoe
3   Real World Study Delivery, Value Evidence and Outcomes, Global Medical, Gsk, Stockley Park, Uxbridge, Middlesex, UK
,
A Maxwell
4   Real World Study Delivery, Value Evidence and Outcomes, Global Medical, Gsk, Stevenage, Hertfordshire, UK
,
S Yang
5   Value Evidence & Outcomes, Gsk, Collegeville, Pa, USA
,
S Joksaite
6   Clinical Statistics, R&d Projects Clinical Platforms and Sciences, Gsk, Stockley Park West, Uxbridge, Middlesex, UK
,
R OʼReilly
4   Real World Study Delivery, Value Evidence and Outcomes, Global Medical, Gsk, Stevenage, Hertfordshire, UK
,
M Van Dyke
7   Epidemiology, Gsk, Upper Providence, Pa, USA
,
FC Albers
8   Respiratory Medical Franchise, Gsk, Research Triangle Park, Nc, USA
,
N Kwon
9   Respiratory Medical Franchise, Gsk, Gsk House, Brentford, Middlesex, UK
› Author Affiliations
Further Information

Publication History

Publication Date:
28 February 2020 (online)

Also available at
 
 

    This abstract will be presented at ERS 2019 in Madrid, Spain.

    Dr. Christina Hermsen is presenting this Encore on behalf of all authors with their permissions.

    Background: Real-world evidence of mepolizumab use for severe eosinophilic asthma (SEA) in routine clinical practice will aid clinical decision making.

    Aims: To assess mepolizumab effectiveness in patients (pts) with SEA in the real world.

    Methods: REALITI-A is a 2y, global, prospective, single-arm, observational cohort study enrolling pts with SEA and newly prescribed mepolizumab 100 mg SC at physicianʼs discretion (no pre-defined eligibility criteria). Data were collected at routine healthcare visits; 1y pre-exposure data were collected retrospectively at enrolment. Primary endpoint was rate of clinically significant exacerbations (CSEs; requiring OCS and/or emergency room [ER] visit/hospitalisation). Exacerbations requiring ER visit/hospitalisation and maintenance OCS use were key secondary endpoints; treatment-related AEs were reported. This interim analysis includes pts with 1y post-exposure data.

    Results: 368 treated pts were included (mean age, 53y; 62% female; geometric mean blood eosinophil count, 370 cells/µL; smoker: former/current 39%, never 61%; 70% on OCS). The rate ratio (RR) of CSEs was 0.31 (95%CI 0.27,0.35; 4.63 [pre-] reduced to 1.43 [post exposure] events/y); RR of exacerbations requiring hospitalisation/ER visits was 0.23 (0.18,0.30; 1.14 reduced to 0.27 events/y). OCS data were available for 159 (baseline) and 143 (Wk 53 – 56) pts. Median OCS dose reduced from 10 to 5 mg/day at Wk 53 – 56; 34% (49/143) stopped OCS. 53 (14%) pts had on-treatment AEs and 2 (< 1%) had serious AEs; there were no fatal AEs.

    Conclusions: This study shows that significant reductions in exacerbations and OCS use with mepolizumab in clinical trials translate to a real-world setting.

    Funding: GSK [204710]


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