Novartis’ Xolair® confirms re-treatment efficacy in chronic spontaneous urticaria patients after treatment interruption

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Novartis International AG /
Novartis’ Xolair® confirms re-treatment efficacy in chronic spontaneous
urticaria patients after treatment interruption
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  • OPTIMA Phase IIIb data re-confirm that almost two thirds of patients treated with Xolair 300 mg for 6 months are well-controlled[1]
  • Should a treatment pause be necessary, data showed almost 90% of chronic spontaneous urticaria (CSU) patients – previously well controlled – regained effective symptom control within 12 weeks of re-treatment on Xolair[2]
  • Previous studies have shown that inadequately controlled CSU has a major impact on sleep, social lives and work[3]

The digital press release with multimedia content can be accessed here:

Basel, September 16, 2017 Novartis, a global leader in Immunology & Dermatology, announced today 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)[2]. 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[4]. International treatment guidelines state that the goal of treatment for CSU is the complete elimination of symptoms[5],[6]. For CSU patients who have not successfully controlled their symptoms with H1 antihistamine (H1-antagonists) treatment, Xolair can reduce or eliminate symptoms[4],[7],[8]. Xolair is the first and only approved therapy for CSU patients who show an inadequate response to H1 antihistamines.

“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, 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.”

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[2]. Symptom control (UAS7=<6) was achieved in almost 90% of retreated patients within three months[2]. Xolair was well-tolerated at both doses and during both dosing periods[2]. 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[2]. 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[1]. After 3 additional doses (300 mg), 45% of these patients achieved symptom control – indicating the importance of up-dosing in some patients[1].

About chronic urticaria and CSU
Chronic urticaria (CU) is a severe disease that is characterized by the reoccurrence of persistent hives and/or sometimes painful deeper swelling of the skin for 6 weeks or more[4]. At any given time, the prevalence of CU is up to 1% of the world’s population, and up to two thirds of these patients have CSU[6] – a form of the condition that can occur unpredictably without an identifiable trigger[6],[9]. Patients with CU remain symptomatic on average for about 5 years, but in some patients, symptoms may persist for decades[10].

Although CU has a significant impact on patients’ quality of life, research has highlighted that some physicians disregard the disease as a trivial condition[10],[11].

OPTIMA is a Phase IIIb, international, multicenter, randomized, open-label, non-comparator study. A …

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