Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies.

ABSTRACT:

Background

Patients with chronic idiopathic/spontaneous urticaria (CIU/CSU) report difficulty with sleep.

Methods

We examined the effect of omalizumab on sleep-related outcomes during 3-6 months omalizumab or placebo treatment and a 16-week follow-up period within three Phase III double-blind randomized placebo-controlled pivotal trials in CIU/CSU: ASTERIA I, ASTERIA II, and GLACIAL. Sleep quality was assessed in all three studies using sleep-related questions included in an electronic diary, the Chronic Urticaria Quality of Life Questionnaire, and the Medical Outcomes Study Sleep Scale. Score changes from baseline in the treatment arms were compared with that in the placebo arm and adjusted for baseline score and weight. We also examined correlations of sleep scores at base

SUBMITTER: Gimenez-Arnau AM 

PROVIDER: S-EPMC4989527 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature