Efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma not receiving inhaled corticosteroids.
Respir Med
; 134: 143-149, 2018 01.
Article
em En
| MEDLINE
| ID: mdl-29413502
ABSTRACT
BACKGROUND:
Asthma is a heterogeneous and complex disease in both its clinical course and response to treatment. IL-13 is central to Type 2 inflammation and contributes to many features of asthma. In a previous Phase 2 study, lebrikizumab, an anti-IL-13 monoclonal antibody, did not significantly improve FEV1 in mild-to-moderate asthma patients not receiving ICS therapy. This Phase 3 study was designed to further assess the efficacy and safety of lebrikizumab in adult patients with mild-to-moderate asthma treated with daily short-acting ß2-agonist therapy alone.METHODS:
Adult patients with mild-to-moderate asthma were randomised to receive lebrikizumab 125â¯mg subcutaneously (SC), placebo SC, or montelukast 10â¯mg orally for 12 weeks, with an 8-week follow-up period. The primary efficacy endpoint was absolute change in pre-bronchodilator FEV1 from baseline at Week 12.FINDINGS:
A total of 310 patients were randomised and dosed in the study. The mean absolute change in FEV1 from baseline at Week 12 was higher in the lebrikizumab-treated arm compared with placebo (150â¯mL versus 67â¯mL); however, this improvement did not achieve statistical significance (overall adjusted difference of 83â¯mL [95% CI -3, 170]; pâ¯=â¯.06). Montelukast did not improve FEV1 as compared with placebo. Lebrikizumab was generally safe and well tolerated during the study.INTERPRETATION:
Lebrikizumab did not significantly improve FEV1 in mild-to-moderate asthma patients at a dose expected to inhibit the IL-13 pathway. Inhibiting IL-13 in this patient population was not sufficient to improve lung function. These data support the findings of a previous trial of lebrikizumab in patients not receiving ICS. CLINICAL TRIALS REGISTRY NUMBER This trial was registered under NCT02104674 at http//www.clinicaltrials.gov.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Asma
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Antiasmáticos
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Anticorpos Monoclonais
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Respir Med
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Estados Unidos