New Phase III trial results of Xolair (Genentech/Roche/Novartis) for patients with Urticaria

Results from a Phase III trial, ASTERIA II, demonstrate that Xolair (omalizumab), from Genentech/Roche and Novartis, met its primary endpoint in patients with moderate to severe chronic Idiopathic Urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses. The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). Three dose groups were chosen and compared to a placebo group. The study met its primary endpoint in two of the three dose groups studied, showing that omalizumab administered every four weeks led to significant improvement in the mean weekly ISS from baseline (approximately 14 in all treatment groups) at Week 12.

The improvements were 8.1 to 9.8 in two of the dose groups, respectively compared to a 5.1 improvement in patients on placebo. One of the dose groups studied did not demonstrate statistical significance. The incidence and severity of adverse events (AEs) was similar across treatment groups. The data were published in the New England Journal of Medicine and will be presented at the American Academy of Allergy, Asthma and Immunology Annual Meeting. See: "Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria." Maurer M, Ros�n K, Hsieh HJ, et al. NEJM 2013; DOI: 10.1056/NEJMoa1215372