Omalizumab Improves Itch in Patients With Chronic Hives
Skin drug meets all primary endpoints in phase III trial (June 26)
Omalizumab (Novartis) has met all primary and secondary endpoints of a pivotal phase III safety registration study in chronic spontaneous urticaria (CSU), a chronic and debilitating form of hives. The new data were presented at the European Academy of Allergy and Clinical Immunology–World Allergy Organization (EAACI–WAO) World Allergy and Asthma Congress 2013 in Milan, Italy.
The GLACIAL trial is the second of three pivotal phase III studies that are investigating the efficacy and safety of omalizumab in CSU. The study results supported the drug’s efficacy, safety, and tolerability in patients with refractory CSU, a chronic and debilitating skin disease with intractable itch and hives. Up to 40% of CSU patients fail on antihistamines, which are currently the only licensed treatment for CSU.
The phase III study also evaluated the effect of treatment on quality of life (QOL). Patients receiving omalizumab experienced nearly double the improvement in QOL compared with placebo (reductions of 9.7 and 5.1, respectively; P < 0.001), as assessed by improvement from baseline in the Dermatology Life Quality Index (DLQI).
Omalizumab-treated patients also experienced a significant increase in the proportion of days free of angioedema (P < 0.001), a painful and disfiguring condition that occurs in approximately 40% to 50% of CSU patients.
Omalizumab is a targeted therapy that binds to immunoglobulin E (IgE). It is not currently approved or indicated for CSU. Research is ongoing to understand the mechanism of action of omalizumab in CSU. The drug may suppress histamine-induced skin reactions through its reduction of IgE and downstream effects on cellular-activation mechanisms.
Omalizumab (Xolair) was approved for the treatment of severe allergic asthma in the U.S. in 2003.
Source: Novartis; June 26, 2013.