New analyses from Phase III studies for Xolair (omalizumab) for Chronic Spontaneous Urticaria-Novartis

Novartis announced new analyses from pivotal Phase III registration studies showing Xolair (omalizumab) helps patients with Chronic Spontaneous Urticaria (CSU) achieve significant improvements in quality of life measures. These findings were presented at the 23rd World Congress of Dermatology (WCD) in Vancouver, Canada. In new post-hoc analyses presented at WCD, patients treated with Xolair for 12 weeks experienced significant improvements in quality of life by 78% (vs placebo 44%, p<0.0001) as measured by the Dermatology Life Quality Index (DLQI) and up to 69% (vs placebo 40%, p<0.0001) using the Chronic Urticaria Quality-of-Life Questionnaire (CU-Q2oL). In addition, the ASSURE-CSU study found that, if left untreated, CSU, has a consistent negative impact on quality of life among patients. This was measured by the Urticaria Activity Score over 7 days (UAS7), CU-Q2oL and DLQI.[3] Similarly, the SOLVE-BOI study found that CSU patients compared to individuals without the disease have higher rates of complaints such as anxiety, depression, sleep difficulty, and lower physical and mental status. They are also 2-3 times more likely to visit a healthcare provider, require emergency medical care, or be hospitalized, and are twice as likely to take time off work (11.3% vs. 5.2%, p<0.0001) or experience overall work impairment (36.9% vs. 20.2%, p<0.0001).

Comment:Results from the three pivotal registration studies for Xolair in CSU were announced in 2013. Highlights from these studies that were previously reported include: 1.In the ASTERIA II study, 44% of patients receiving Xolair 300 mg were itch-and hive-free after 12 weeks of treatment (p<0.0001)]. 2.In the ASTERIA I study, Xolair-treated patients experienced a rapid reduction in itch and hives as early as Week 1, with the therapeutic benefit sustained over 24 weeks of active treatment (p<0.0001). 3.In the GLACIAL study, more than half of patients who had failed multiple therapies including H1 antihistamines (at up to four times the approved dose) and H2 antihistamines and/or leukotriene receptor antagonists (LTRAs) had their symptoms eliminated or suppressed with Xolair 300 mg (p<0.001).