The FINANCIAL — Omalizumab met all primary and secondary endpoints of a pivotal Phase III safety registration study in chronic spontaneous urticaria (CSU), a chronic and debilitating form of hives with limited approved treatment options, according to Novartis, a Swiss multinational pharmaceutical company.
"This is encouraging news for people living with CSU, whose quality of life is greatly impacted by this serious disease and who currently have few treatment options," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Novartis is committed to doing all we can for these patients by working to develop an important advance in CSU treatment, where unmet medical need remains high," he added.
Specifically, more than one third of omalizumab-treated patients in the GLACIAL study were completely itch- and hive-free by Week 12, compared to 5% of placebo-treated patients. During the same time period, the proportion of patients with well controlled CSU symptoms (itch, hives) was four times higher in the omalizumab group compared to placebo. The significant improvements observed with omalizumab were sustained throughout the treatment period up to Week 24, according to Novartis.
Up to 80% of patients with CSU suffer negative effects on their quality of life including sleep deprivation and psychological comorbidities such as depression and anxiety, the study shows. Patients receiving omalizumab experienced nearly double the improvement in a quality of life measure compared to placebo. This is significant, given that at the start of the study patients in both groups had a baseline score of over 12, indicating a severe impact on a patient's quality of life. Omalizumab reduced the score by nearly 10 points by Week 12, lowering the DLQI score to 2.3. This signified a marked improvement in patients' quality of life, according to Novartis.
Omalizumab-treated patients also experienced a significant increase in the proportion of days free of deep tissue swelling, also known as angioedema. Angioedema is a painful and disfiguring condition experienced by approximately 40%-50% of patients with CSU, the study shows.
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