Lamiae Grimaldi-Bensouda1, Mahmoud Zureik2, Michel Aubier3, Marc Humbert4, Jean Levy5, Jacques Benichou6, Mathieu Molimard7, Lucien Abenhaim8. 1. LA-SER, Paris, France; Equipe d'accueil 'Pharmacoépidémiologie et Maladies Infectieuses', Institut Pasteur, Paris, France. Electronic address: Lamiae.Grimaldi@la-ser.com. 2. INSERM U744, Institut Pasteur de Lille, Lille, France. 3. Service de Pneumologie A, Hôpital Bichat, Paris, France. 4. Université Paris-Sud, Kremlin-Bicêtre, France; Assistance Publique-Hopitaux de Paris, Service de Pneumologie, DHU Thorax Innovation, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; INSERM U999, LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson, France. 5. Clinique de Pneumologie, Saint-Ouen, France. 6. Unité de Biostatistique, Centre Hospitalier Universitaire de Rouen, Rouen, France; INSERM U657, Institut Hospitalo-Universitaire de Recherche Biomédicale, Université de Rouen, Rouen, France. 7. Université de Bordeaux, Bordeaux, France; INSERM U657, Bordeaux, France; Service de Pharmacologie, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France. 8. Department of Epidemiology, London School of Hygiene & Tropical Medicine, London, England; LA-SER Europe Ltd, London, England.
Abstract
BACKGROUND: Omalizumab has been shown to decrease the risk of hospitalization or ED visits in patients with uncontrolled severe allergic asthma compared with placebo. This longitudinal study observed the conditions under which omalizumab is prescribed in real-life settings and assessed whether its use as an add-on therapy alongside standard treatments decreases the risk of severe asthmatic exacerbations. METHODS: A cohort of adult patients with uncontrolled severe asthma despite optimal treatment with inhaled and oral corticosteroids and a long-acting b 2 -agonist but no treatment with omalizumab upon entry was assembled. Risk of hospitalization or ED visits for asthma exacerbation was assessed using the Andersen-Gill extension of the Cox model for repeated events, controlling for age, sex, smoking history, BMI, gastroesophageal reflux, allergic status, allergic rhinitis, treatment, and hospitalization or ED visits for asthma in the 2 months prior to omalizumab treatment. RESULTS: Overall, 163 physicians recruited 767 patients, of whom 374 took omalizumab at least once (mean observation period, 20.4 months). Omalizumab use was associated with an adjusted relative risk of 0.57 (95% CI, 0.43-0.78) for hospitalization or ED visits for asthma. In users of omalizumab, the adjusted relative risk of hospitalization or ED visits for asthma during omalizumab treatment vs nontreatment periods was 0.40 (95% CI, 0.28-0.58). CONCLUSIONS: Add-on omalizumab is associated with a significantly decreased risk of hospitalization or ED visits in patients with uncontrolled severe asthma in real-life practice.
BACKGROUND:Omalizumab has been shown to decrease the risk of hospitalization or ED visits in patients with uncontrolled severe allergic asthma compared with placebo. This longitudinal study observed the conditions under which omalizumab is prescribed in real-life settings and assessed whether its use as an add-on therapy alongside standard treatments decreases the risk of severe asthmatic exacerbations. METHODS: A cohort of adult patients with uncontrolled severe asthma despite optimal treatment with inhaled and oral corticosteroids and a long-acting b 2 -agonist but no treatment with omalizumab upon entry was assembled. Risk of hospitalization or ED visits for asthma exacerbation was assessed using the Andersen-Gill extension of the Cox model for repeated events, controlling for age, sex, smoking history, BMI, gastroesophageal reflux, allergic status, allergic rhinitis, treatment, and hospitalization or ED visits for asthma in the 2 months prior to omalizumab treatment. RESULTS: Overall, 163 physicians recruited 767 patients, of whom 374 took omalizumab at least once (mean observation period, 20.4 months). Omalizumab use was associated with an adjusted relative risk of 0.57 (95% CI, 0.43-0.78) for hospitalization or ED visits for asthma. In users of omalizumab, the adjusted relative risk of hospitalization or ED visits for asthma during omalizumab treatment vs nontreatment periods was 0.40 (95% CI, 0.28-0.58). CONCLUSIONS: Add-on omalizumab is associated with a significantly decreased risk of hospitalization or ED visits in patients with uncontrolled severe asthma in real-life practice.
Authors: María Del Carmen Vennera; Antonio Valero; Estefany Uría; Carles Forné; César Picado Journal: Clin Drug Investig Date: 2016-07 Impact factor: 2.859