Omalizumab for treating chronic spontaneous urticaria: an expert review on efficacy and safety

ABSTRACT

Introduction: Chronic spontaneous urticaria (CSU) is characterized by the recurrence of itchy hives and/or angioedema for greater than six weeks, with no known external trigger. Omalizumab, a humanized, recombinant, monoclonal anti-IgE antibody, is the only approved add-on therapy for H1-antihistamine refractory CSU patients.

Areas covered: The objective of this article is to discuss the mechanism of action, pharmacokinetics and pharmacodynamics of omalizumab for the treatment of CSU. The review also summarizes efficacy and safety data from proof-of-concept, phase II (X-CUISITE, MYSTIQUE), and pivotal phase III omalizumab studies (ASTERIA I, ASTERIA II, and GLACIAL).

Expert opinion: Omalizumab is a clinically effective and safe biological therapy for treating H1-antihistamine refractory CSU patients. It significantly reduces CSU symptoms (hives, itch and angioedema), and improves patient health-related quality of life. While omalizumab is already integral to the treatment of antihistamine refractory CSU, widespread use will depend on legal and economic factors, as well as improvements in the early and accurate diagnosis of CSU patients who would benefit from treatment.

KEYWORDS:

• Anti-IgE
• chronic urticaria
• chronic idiopathic urticaria
• chronic spontaneous urticaria
• omalizumab

Acknowledgments

Medical writing support was provided by Áine Abautret-Daly (Novartis Ireland Ltd., Dublin, Ireland). The publication presents the expert opinions of the author and not Novartis.

Declaration of interest

Ana Giménez-Arnau is a medical advisor for Uriach Pharma, Genentech, Novartis, and Almirall; has received research grants Intendis-Bayer, Uriach Pharma, and Novartis; and has had educational activities sponsored by Uriach Pharma, Novartis, Genentech, Menarini, GlaxoSmithKline, Merck Sharp and Dohme, and Almirall. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance was utilized in the production of this manuscript and funded by Novartis.

Reprinted from Casale et al. [31] with permission of Elsevier.

Additional information

Funding

Medical writing support was funded by Novartis Pharma AG, Basel, Switzerland.