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DOI: 10.1055/s-0039-3403113
Long-term safety and durability of mepolizumab in life-threatening/seriously debilitating severe eosinophilic asthma (SEA): COSMEX
Publication History
Publication Date:
28 February 2020 (online)
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]
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