Pneumologie 2020; 74(S 01): 24
DOI: 10.1055/s-0039-3403113
Posterbegehung (PO03) – Sektion Klinische Pneumologie
Neues zum Asthma bronchiale – Schwerpunkt schweres Asthma
Georg Thieme Verlag KG Stuttgart · New York

Long-term safety and durability of mepolizumab in life-threatening/seriously debilitating severe eosinophilic asthma (SEA): COSMEX

FC Albers
1   Respiratory Medical Franchise, Gsk, Research Triangle Park, Nc, USA
,
S Khurana
2   Department of Medicine/Pulmonary, University of Rochester Medical Center, Rochester, Ny, USA
,
E Bradford
3   Respiratory Therapeutic Area, Gsk, Research Triangle Park, Nc, USA
,
M Gilson
4   Respiratory Research and Development, Gsk, Stockley Park, Uxbridge, Middlesex, UK
,
R Price
5   Clinical Statistics, Gsk, Stevenage, Hertfordshire, UK
,
G Brusselle
6   Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium
,
E Bel
7   Department of Respiratory Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands
,
JM FitzGerald
8   Department of Medicine, University of British Columbia, Vancouver, Bc, Canada
,
M Masoli
9   Department of Respiratory Medicine, Plymouth Hospitalʼs NHS Trust, Plymouth, UK
,
S Korn
10   Universitätsmedizin Mainz, Mainz, Germany
,
M Humbert
11   Assistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Université Paris-Sud, and Inserm U 999, Le Kremlin-Bicêtre, France
› Author Affiliations
Further Information

Publication History

Publication Date:
28 February 2020 (online)

Also available at
 

This abstract was previously presented at ERS 2018 in Paris, Eur Respir J 2018; 52(Suppl 62): OA3566. Mariola Bednorz is presenting this Encore on behalf of all authors with their permissions.

Background: Safety & durability of mepolizumab were limited in pts with the most severe form of SEA.

Objective: To assess the long-term safety & durability of mepolizumab in these SEA pts.

Methods: COSMEX was an open-label extension of COSMOS (a 52-wk extension of mepolizumab Ph3 trials)*. Pts had life-threatening/seriously debilitating asthma prior to Ph3 trials (≥ 1 intubation [lifetime]; ≥ 1 hospitalisation or ≥ 3 exacerbations [12 m prior]; OCS dose ≥ 10 mg [randomisation]; %predFEV1 ≤ 50% + ACQ-5 score ≥ 3 or SGRQ score ≥ 60) & improved on mepolizumab (≥ 50% reduction in exacerbations/OCS dose & investigator-confirmed improvement) during the previous studies. Coprimary endpoints: frequency of AEs & exacerbation rate; other endpoint: OCS reduction.

Results: 339 pts entered COSMEX. Total mepolizumab exposure over COSMEX was 718 pt-yr (mean 25 m[range 2 – 39 m] & over COSMEX & previous studies was 1202 pt-yr [mean 43 m (range 14 – 57 m)]). See table for coprimary endpoint results; no new safety signals seen. Exacerbation & OCS reductions achieved in the previous studies were sustained over COSMEX (median OCS dose maintained at 0 – 5 mg/day).

Conclusions: In these SEA pts, the safety profile of mepolizumab was similar to previous shorter-term trials, with no new safety signals; long-term treatment provided sustained & consistent exacerbation & OCS reductions for up to 4.5 yrs.

Funding: GSK [201312/NCT02135692]