作者: J. Bousquet , P. Cabrera , N. Berkman , R. Buhl , S. Holgate
DOI: 10.1111/J.1398-9995.2004.00770.X
关键词:
摘要: Background: Patients with severe persistent asthma who are inadequately controlled despite treatment according to current management guidelines have a significant unmet medical need. Such patients at high risk of serious exacerbations and asthma-related mortality. Methods: Here, we pooled data from seven studies determine the effect omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, on in asthma. Omalizumab was added therapy compared placebo (in five double-blind studies) or alone two open-label studies). The included 4308 (2511 treated omalizumab), 93% whom had Global Initiative for Asthma (GINA) 2002 classification. Using Poisson regression model, results were calculated as ratio (omalizumab : control) standardized exacerbation rate per year. Results: significantly reduced by 38% (P < 0.0001 vs control) total emergency visits 47% control). Analysis demographic subgroups showed that efficacy omalizumab unaffected patient age, gender, baseline serum IgE (split median) 2- 4-weekly dosing schedule, although benefit absolute terms appeared be greatest more asthma, defined lower value percentage predicted forced expiratory volume 1 s (FEV1) baseline. Conclusions: These suggest may fulfil important need many not adequately therapy.