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

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  • dc.contributor.author Giménez Arnau, Anna Mariaca
  • dc.contributor.author Spector, Sheldonca
  • dc.contributor.author Antonova, Evgeniyaca
  • dc.contributor.author Trzaskoma, Benjaminca
  • dc.contributor.author Rosén, Karinca
  • dc.contributor.author Omachi, Theodore A.ca
  • dc.contributor.author Stull, Donaldca
  • dc.contributor.author Balp, Maria Magdalenaca
  • dc.contributor.author Murphy, Thomasca
  • dc.date.accessioned 2017-01-30T08:31:17Z
  • dc.date.available 2017-01-30T08:31:17Z
  • dc.date.issued 2016
  • dc.description.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 baseline, week 12, and week 24 and the slopes of change between sleep and itch and hive. RESULTS: Patients treated with omalizumab reported a larger reduction in sleep problems than those in the placebo arm; omalizumab 300 mg demonstrated the greatest improvement on all sleep components among all treatment arms. The largest reduction in sleep problems was reported within the first 4 weeks of therapy. After treatment discontinuation, sleep quality worsened. Sleep scores demonstrated moderate-to-strong correlation between them, and the change in sleep scores was associated with changes in itch and hives. CONCLUSIONS: Improvement in sleep was reported after the first dose of omalizumab. Sleep continued to improve throughout the active treatment period. Patients receiving omalizumab 300 mg achieved greater improvement in sleep than those in other treatment arms. Trial registration ClinicalTrials.gov, NCT01287117 (ASTERIA I), NCT01292473 (ASTERIA II), and NCT01264939 (GLACIAL).ca
  • dc.description.sponsorship The funding for ASTERIA I, ASTERIA II, and GLACIAL was provided by Genentech, Inc., South San Francisco, CA, USA and Novartis Pharma AG, Basel, Switzerland. The funding for this study was provided by Genentech, Inc. Medical writing support for this manuscript was provided by Charlotte Kenreigh of Excel Scientific Solutions and funded by Genentech, Inc. and Novartis Pharmaceuticals Corporation.
  • dc.format.mimetype application/pdfca
  • dc.identifier.citation Gimenéz-Arnau AM, Spector S, Antonova E, Trzaskoma B, Rosén K, Omachi TA. et al. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies. Clin Transl Allergy. 2016 Aug 18;6:32. doi: 10.1186/s13601-016-0120-0ca
  • dc.identifier.doi http://dx.doi.org/10.1186/s13601-016-0120-0
  • dc.identifier.issn 2045-7022
  • dc.identifier.uri http://hdl.handle.net/10230/28012
  • dc.language.iso engca
  • dc.publisher BioMedCentralca
  • dc.relation.ispartof Clinical and Translational Allergy. 2016 Aug 18;6:32
  • dc.rights © The Author(s) 2016. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.ca
  • dc.rights.accessRights info:eu-repo/semantics/openAccessca
  • dc.rights.uri https://creativecommons.org/licenses/by/4.0/ca
  • dc.subject.other Urticàriaca
  • dc.subject.other Son -- Aspectes fisiològicsca
  • dc.subject.other Trastorns del son -- Medicamentsca
  • dc.title Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies.ca
  • dc.type info:eu-repo/semantics/articleca
  • dc.type.version info:eu-repo/semantics/publishedVersionca

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