The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma.
Allergy
; 74(9): 1716-1726, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-31049972
ABSTRACT
BACKGROUND:
Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes.OBJECTIVE:
To assess if patients eligible for both biologics but not optimally controlled with omalizumab experience improved asthma control when switched directly to mepolizumab.METHODS:
OSMO was a multicenter, open-label, single-arm, 32-week trial in patients with ≥2 asthma exacerbations in the year prior to enrollment, despite receiving high-dose inhaled corticosteroids and other controller(s), plus omalizumab (≥4 months). At baseline, patients with blood eosinophil counts ≥150 cells/µL (or ≥300 cells/µL in the prior year) and an Asthma Control Questionnaire (ACQ)-5 score ≥1.5 discontinued omalizumab and immediately commenced mepolizumab 100 mg subcutaneously every 4 weeks. Endpoints included change from baseline in ACQ-5 score (primary), St George's Respiratory Questionnaire (SGRQ) score and the proportions of ACQ-5 and SGRQ responders, all at Week 32, and the annualized exacerbation rate over the study period.RESULTS:
At Week 32 (intent-to-treat population [n = 145]), the least squares (LS) mean changes (standard error [SE]) in ACQ-5 and SGRQ total scores were -1.45 (0.107) and -19.0 (1.64) points; with 77% and 79% of patients achieving the minimum clinically important differences (ACQ-5 ≥0.5 points; SGRQ ≥4 points), respectively. The annualized rate of clinically significant exacerbations was 1.18 events/year, a 64% reduction from 3.26 events/year during the previous year. Safety and immunogenicity profiles were consistent with previous trials.CONCLUSION:
After directly switching from omalizumab to mepolizumab, patients with uncontrolled severe eosinophilic asthma experienced clinically significant improvements in asthma control, health status, and exacerbation rate, with no tolerability issues reported.Palavras-chave
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Base de dados:
MEDLINE
Assunto principal:
Asma
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Antiasmáticos
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Eosinófilos
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Substituição de Medicamentos
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Anticorpos Monoclonais Humanizados
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
Limite:
Adolescent
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Adult
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Aged
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Child
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article