OPTIMA study shows urticaria patients respond well to re- treatment with Xolair (omalizumab)-Novartis.

Novartis, announced new data showing almost 90% of chronic spontaneous urticaria (CSU) patients who responded well to initial Xolair (omalizumab) treatment regained symptom control within 12 weeks of Xolair retreatment following a treatment interruption, based on Weekly Urticaria Activity Score (UAS7) criteria (UAS7=<6). Findings were presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress in Geneva, Switzerland. CSU is a distressing skin condition that appears spontaneously and causes persistent hives and/or painful deeper swelling of the skin for 6 weeks or more. International treatment guidelines state that the goal of treatment for CSU is the complete elimination of symptoms.

For CSU patients who have not successfully controlled their symptoms with H1 antihistamine (H1-antagonists) treatment, Xolair can reduce or eliminate symptoms. Xolair is the first and only approved therapy for CSU patients who show an inadequate response to H1 antihistamines. In the OPTIMA study, 314 participants with symptoms of CSU despite taking H1 antihistamines were randomized to 24 weeks of treatment with either Xolair 150 mg or 300 mg. Individuals who responded well to this initial treatment (UAS7=<6) underwent a pause in treatment and then, if symptoms returned (UAS7>16), were retreated. Symptom control (UAS7=<6) was achieved in almost 90% of retreated patients within three months. Xolair was well-tolerated at both doses and during both dosing periods.

Further data from OPTIMA showed that, after 24 weeks of treatment, 65% of participants treated monthly with Xolair 300 mg were well-controlled (UAS7=<6) compared to 15% treated with 150 mg. Between 8 and 24 weeks of treatment, 79% of patients starting on Xolair 150 mg were not well-controlled (UAS7>6) and had their dose increased to 300 mg. After 3 additional doses (300 mg), 45% of these patients achieved symptom control - indicating the importance of up-dosing in some patients.

Comment: Xolair is approved for the treatment of CSU in over 80 countries including the European Union and for chronic idiopathic urticaria (CIU) as it is known in the US and Canada. Xolair is approved for the treatment of moderate-to-severe or severe persistent allergic asthma in more than 90 countries, including the US since 2003 and the EU since 2005 and has over 800,000 patient years of exposure. In addition, a liquid formulation of Xolair in pre-filled syringes has been approved in the EU and 10 countries outside of the EU, including Canada and Australia. In the US, Novartis Pharmaceuticals Corporation and Genentech, Inc. work together to develop and co-promote Xolair..