Omalizumab safe and effective as add-on therapy to corticosteroids in asthma (meta-analysis)

Omalizumab is a humanized monoclonal anti-IgE for the treatment of severe allergic asthma. Because omalizumab targets an immune system molecule (IgE and its receptors), there has been particular interest in the drug's safety.

This meta-analysis included 8 trials with 3,400 participants.

At the end of the steroid-reduction phase, patients taking omalizumab were more likely to be able to withdraw from corticosteroids completely compared with those taking placebo (relative risk [RR] = 1.80).

Omalizumab patients showed a decreased risk of asthma exacerbations (RR = 0.56).

The frequency of serious adverse effects was similar in the omalizumab (3.8%) and placebo (5.3%) groups. However, injection site reactions were more frequent in the omalizumab patients (20% vs. 13%).

There were no indications of increased risk of hypersensitivity reactions, cardiovascular effects, or malignant neoplasms. A causal relationship between omalizumab therapy and malignancy is unlikely [J Allergy Clin Immunol. 2012].

In school-aged children, adolescents, and adults with moderate-to- severe persistent allergic asthma, subcutaneous injection of omalizumab (0.016 mg/kg/international units/mL every 2 to 4 weeks depending on body weight) was superior to placebo in preventing asthma exacerbations.

Limitations of the systematic review include identification of only 2 trials that recruited pediatric participants. Also the study period was not long enough, for example, no significant adverse effects were seen among patients taking omalizumab in studies shorter than 1 year.

In this interview, JACI Associate Editors Dr. Dennis Ledford and Dr. Stanley Szefler discuss Dr. Szefler's article "Incidence of malignancy in moderate-to-severe asthmatics treated with or without omalizumab". No significantly increased risk after 5 years of omalizumab therapy. However, the malignancy risk is on the official label and the FDA does not have a history of removing warnings from drug labels.


Efficacy and Safety of Subcutaneous Omalizumab vs Placebo as Add-on Therapy to Corticosteroids for Children and Adults With Asthma: A Systematic Review. Rodrigo GJ, Neffen H, Castro-Rodriguez JA. Chest. 2011 Jan;139(1):28-35. Epub 2010 Aug 5.
Humanized Monoclonal Antibody May Be Effective, Safe in Asthma Patients. Medscape, 2011.
Omalizumab in Severe Asthma Inadequately Controlled With Standard Therapy reduces asthma exacerbations by 25% (RR), Annals of Int Medicine, 2011.
Omalizumab in children with severe persistent asthma uncontrolled on standard therapy - AAAAI Ask the Expert answers:
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