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Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study
Allergy, Asthma & Immunology Research ; : 319-328, 2016.
Artigo em Inglês | WPRIM | ID: wpr-49796
ABSTRACT

PURPOSE:

Omalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma.

METHODS:

This randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age).

RESULTS:

A total of 616 patients were randomized (11) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; P<0.001) and ACQ (49.5% vs 35.5%; LSM=-0.51 vs -0.34; P=0.002) scores vs placebo. Total and nighttime symptom scores reduced significantly with omalizumab vs placebo (LSM-TD=-0.21, P=0.048 and -0.12, P=0.011, respectively). Although the study was not powered to study differences in exacerbation rates (P=0.097), exacerbations in winter months were less frequent in the omalizumab vs placebo group (2 vs 21). Adverse event and severe adverse event rates were comparable between omalizumab and placebo.

CONCLUSIONS:

Omalizumab improves lung function, quality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile.
Assuntos

Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Assunto principal: Qualidade de Vida / Asma / Análise dos Mínimos Quadrados / China / Povo Asiático / Alergia e Imunologia / Omalizumab / Pulmão Tipo de estudo: Ensaio Clínico Controlado / Guia de Prática Clínica / Estudo prognóstico Limite: Humanos País/Região como assunto: Ásia Idioma: Inglês Revista: Allergy, Asthma & Immunology Research Ano de publicação: 2016 Tipo de documento: Artigo

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Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Assunto principal: Qualidade de Vida / Asma / Análise dos Mínimos Quadrados / China / Povo Asiático / Alergia e Imunologia / Omalizumab / Pulmão Tipo de estudo: Ensaio Clínico Controlado / Guia de Prática Clínica / Estudo prognóstico Limite: Humanos País/Região como assunto: Ásia Idioma: Inglês Revista: Allergy, Asthma & Immunology Research Ano de publicação: 2016 Tipo de documento: Artigo