Patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) who were treated with omalizumab reported a reduction in sleep problems compared with those who received placebo, according to a study presented here at the Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI).
"Improvement in sleep impairment was achieved after 4 weeks" wrote Evgeniya Antonova, PhD, Genentech, San Francisco, California, and colleagues in their poster presentation.
CIU/CSU greatly affects patient health-related quality of life, and its symptoms often result in poor sleep quality and inadequate duration.
For the current analysis, researchers scrutinised patient-reported data on sleep from the randomised, double-blind, placebo-controlled GLACIAL trial, which included patients aged 12 to 75 years with CIU/CSU who remained symptomatic on H1-antihistamine treatment plus H2-antihistamines and/or leukotriene receptor antagonists.
Patients were randomised to receive either omalizumab 300 mg (n = 252) or placebo (n = 83) every 4 weeks for a total of 6 doses, and they were followed for an additional 16 weeks of observation after the dosing was completed.
The patients' sleep quality was evaluated using the Urticaria Patient Daily Diary (UPDD; sleep interference question), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL; sleep problems dimension), and the Medical Outcomes Study Sleep Scale (MOS-SS; sleep problem index II [SPIII]).
By week 12, patients in both the treatment and placebo groups experienced improvement in sleep, compared with baseline. However, the omalizumab group showed a larger reduction in patient-reported sleep problems than the placebo group (mean, % reduction) for MOS-SS SPI-II scores (-19.0 vs -13.4); for UPDD sleep interference item score (-9.2 vs -5.0); and for the CU-Q2oL Sleep Problems score (- 29.4 vs -18.3).
Funding for this study was provided by Genentech, Inc. and Novartis Pharma AG.