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Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.

Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment.

Author information

1
INSERM UMR 1087 CNRS UMR 6291, L'Institut du Thorax, CHU de Nantes, Université de Nantes, Nantes, France.
2
Département de Pneumologie et Addictologie, INSERM U1046, CNRS UMR 9214, Hôpital Arnaud de Villeneuve CHU Montpellier, and PhyMedExp, University of Montpellier, Montpellier, France.
3
Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.
4
Clinical Statistics, GSK, Uxbridge, Middlesex, UK.

Abstract

BACKGROUND:

We performed post hoc analyses to evaluate the effect of humanized monoclonal antibody mepolizumab in patients with severe eosinophilic asthma previously treated with omalizumab.

METHODS:

Data were collected from two randomized double-blind, placebo-controlled studies: MENSA (NCT01691521: 32-week treatment phase) and SIRIUS (NCT01691508: 24-week treatment phase). Active treatment was 75 mg intravenous mepolizumab (MENSA) or 100 mg subcutaneous mepolizumab (MENSA, SIRIUS). Patients had evidence of eosinophilic inflammation ≥150 cells/μl (at screening) or ≥300 cells/μl (during the previous year). Primary outcomes were the rate of exacerbations (MENSA) and the percentage reduction in oral corticosteroid (OCS) dose (SIRIUS). Other outcomes included lung function (forced expiratory volume in 1 s and morning peak expiratory flow), Asthma Control Questionnaire (ACQ-5), St George's Respiratory Questionnaire (SGRQ) scores, and safety.

RESULTS:

Overall, 576 patients were included from MENSA and 135 from SIRIUS, with 13% and 33% previously receiving omalizumab, respectively. In MENSA, mepolizumab reduced the rate of exacerbations by 57% (prior omalizumab) and 47% (no prior omalizumab) vs placebo. In SIRIUS, reductions in OCS use were comparable regardless of prior omalizumab use. Despite reducing chronic OCS use, mepolizumab also resulted in similar reductions in exacerbation rate relative to placebo in both subgroups. Asthma control and quality of life improved with mepolizumab vs placebo in both studies independent of prior omalizumab use, as shown by ACQ-5 and SGRQ scores. Adverse events were also comparable irrespective of prior omalizumab use.

CONCLUSIONS:

These post hoc analyses indicate that patients with severe eosinophilic asthma respond positively to mepolizumab regardless of prior use of omalizumab.

KEYWORDS:

mepolizumab; omalizumab; severe eosinophilic asthma

PMID:
27087007
PMCID:
PMC5089585
DOI:
10.1111/all.12914
[Indexed for MEDLINE]
Free PMC Article

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