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Original Research: Asthma |

Does Omalizumab Make a Difference to the Real-life Treatment of Asthma Exacerbations?Real-Life Effectiveness of Omalizumab in Asthma: Results From a Large Cohort of Patients With Severe Uncontrolled Asthma

Lamiae Grimaldi-Bensouda, PharmD, PhD; Mahmoud Zureik, MD, PhD; Michel Aubier, MD, PhD; Marc Humbert, MD, PhD; Jean Levy, MD; Jacques Benichou, MD, PhD; Mathieu Molimard, MD, PhD; Lucien Abenhaim, MD, PhD; for the Pharmacoepidemiology of Asthma and Xolair (PAX) Study Group
Author and Funding Information

From LA-SER (Dr Grimaldi-Bensouda), Paris, France; Equipe d’accueil ‘Pharmacoépidémiologie et Maladies Infectieuses’ (Dr Grimaldi-Bensouda), Institut Pasteur, Paris, France; INSERM U744 (Dr Zureik), Institut Pasteur de Lille, Lille, France; Service de Pneumologie A (Prof Aubier), Hôpital Bichat, Paris, France; Université Paris-Sud (Prof Humbert), Kremlin-Bicêtre, France; Assistance Publique-Hopitaux de Paris (Prof Humbert), Service de Pneumologie, DHU Thorax Innovation, Hôpital Bicêtre, Le Kremlin-Bicêtre, France; INSERM U999 (Prof Humbert), LabEx LERMIT, Centre Chirurgical Marie-Lannelongue, Le Plessis-Robinson, France; Clinique de Pneumologie (Dr Levy), Saint-Ouen, France; Unité de Biostatistique (Prof Benichou), Centre Hospitalier Universitaire de Rouen, Rouen, France; INSERM U657 (Prof Benichou), Institut Hospitalo-Universitaire de Recherche Biomédicale, Université de Rouen, Rouen, France; Université de Bordeaux (Prof Molimard), Bordeaux, France; INSERM U657 (Prof Molimard), Bordeaux, France; Service de Pharmacologie (Prof Molimard), Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; Department of Epidemiology (Prof Abenhaim), London School of Hygiene & Tropical Medicine, London, England; and LA-SER Europe Ltd (Prof Abenhaim), London, England.

Correspondence to: Lamiae Grimaldi-Bensouda, PharmD, PhD, LA-SER, 10 Place de Catalogne, 75014 Paris, France; e-mail: Lamiae.Grimaldi@la-ser.com


Members of the collaborating Pharmacoepidemiology of Asthma and Xolair Study Group are listed in e-Appendix 1.

Funding/Support: Novartis Pharma SAS provided financial support.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2013;143(2):398-405. doi:10.1378/chest.12-1372
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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 β2-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.


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