Safety of omalizumab in asthma.

INTRODUCTION: Omalizumab is the first mAb to be introduced for the management of asthma. It is also the first agent designed to block the effects of IgE in initiating the allergic cascade resulting in asthma manifestations. Introduced in 2003, it is now widely used as an effective therapeutic tool in moderate-to-severe allergic asthmatics who are uncontrolled on maximal conventional therapy, including high-dose inhaled steroids and long-acting β-agonists. There is still understandable concern regarding the long-term effects of this drug. AREAS COVERED: The authors provide a review of safety data generated by controlled clinical trials and post-marketing surveillance as well as a brief overview of the clinical indications and efficacy of omalizumab. They also address specific issues of concern, including the risk of anaphylaxis and malignancy. The reader will gain a working knowledge of the role of omalizumab in current guidelines for the management of asthma. EXPERT OPINION: Omalizumab appears to be safe and well-tolerated. The possible association of malignancy with omalizumab has been of the greatest concern to patients and physicians. Analysis of clinical study data shows that this incidence is rare and the relative risk of cancer with omalizumab is not significantly different from that which is expected in the general population of people with asthma. As part of a relatively new class of agents, continued surveillance is needed as its indications expand and its use in the population continues to grow.