Xolair Reduced Urticarial Symptoms More Than Expected

According to data from a study presented at the 2017 AAAAI Annual Meeting, longer-term utilization of Xolair (omalizumab; Genentech) produced positive responses in a larger number of patients than expected.

During the XTEND-CIU trials—a phase 4, multicenter, randomized, double-blind, placebo-controlled study—the researchers observed 206 patients over a period of 48 weeks in order to determine the long-term efficacy of Xolair. 

“XTEND-CIU was designed to assess the safety and efficacy of longer-term [Xolair] treatment (48 weeks) and enhance understanding of [Xolair] discontinuation in patients with chronic idiopathic urticarial,” Thomas B Casale, MD, professor of the department pediatrics at the University of South Florida School of Medicine, and colleagues wrote.

Dr Casale and colleagues studied a cohort of patients aged older than 12 years with chronic idiopathic urticarial symptoms despite standard H1 antihistamine treatment, H2 blockers, and/or leukotriene receptor modifiers. The study consisted of four phases including a 14-day screening phase, a 24-week open-label phase, a 24-week randomized double-blind phase, and a follow up phase at 48 to 60 weeks. Patients either received 300 mg of Xolair or placebo every 4 weeks. In order to be enrolled in randomization, patients had to obtain an Urticaria Activity Score (UAS7) of less than 6 during the second phase of the study. The researcher projected at least 57% of patients would be eligible for randomization. 

The researchers found that 65% of patients achieved UAS7 scores of 6 or less and moved to the randomization phase of the study. Study results also showed that at the end of the open-label phase, average UAS7 scores and weekly itch scores decreased among all study participants. 

“A higher-than-expected number of patients responded to [Xolair] during the 24-week open-label period and were eligible for randomization in the subsequent double-blind period,” Dr Casale and
colleagues concluded. —David Costill