Novartis' Xolair shows strong retreatment efficacy at Phase 3 in chronic spontaneous urticaria

Novartis has released new data demonstrating the efficacy of Xolair (omalizumab) in the treatment of chronic spontaneous urticaria (CSU), a severe condition which causes persistent hives and painful deep swelling of the skin. 

International treatment guidelines deem treatment of CSU successful once complete elimination of symptoms is achieved. Xolair is indicated in the treatment of CSU in patients who are not able to successfully control their symptoms with H1 antihistamines (H1-antagonists), being the first and only approved therapy of its kind.  

In the recent Phase 3b trial, 314 participants who could not control their symptoms with H1 antihistamines were given either 150mg or 300mg of Xolair over 24 weeks. Patients who responded well to initial treatment, as determined by Weekly Urticaria Activity Score criteria (UAS7≤6), had their regimen paused; in those who experienced resurgence in symptoms, defined by a score of UAS7≤16, were retreated.

It was found that Xolair produced 90% symptom control in these retreated patients within three months. Additionally, 65% of patients treated with 300mg Xolair achieved UAS7≤6 after 24 weeks, compared to 15% of those taking 150mg. 79% of the 150mg group had their doses increased to 300mg between week 8 and 24, having failed to reach this goal. Following three additional increased doses, 45% of these patients achieved symptom control.

"CSU can have a severe impact on quality of life. Its unpredictable nature, combined with the fact that some physicians mistakenly dismiss it as a trivial condition, can mean patients do not get adequate treatment with effective and long-term symptoms control," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer at Novartis. "If for some reason treatment has been interrupted, these data give patients and physicians confidence that it’s possible to regain effective symptom control with Xolair."