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Clinical and Translational Allergy
Published in: Clinical and Translational Allergy 1/2016

Open Access 01-12-2016 | Research

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

Authors: Ana M. Gimenéz-Arnau, Sheldon Spector, Evgeniya Antonova, Benjamin Trzaskoma, Karin Rosén, Theodore A. Omachi, Donald Stull, Maria-Magdalena Balp, Thomas Murphy

Published in: Clinical and Translational Allergy | Issue 1/2016

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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)
Appendix
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Literature
1.
2.
Foley D, Ancoli-Israel S, Britz P, Walsh J. Sleep disturbances and chronic disease in older adults: results of the 2003 National Sleep Foundation Sleep in America Survey. J Psychosom Res. 2004;56:497–502.CrossRefPubMed
3.
Ford ES, Cunningham TJ, Giles WH, Croft JB. Trends in insomnia and excessive daytime sleepiness among U.S. adults from 2002 to 2012. Sleep Med. 2015;2015(16):372–8.CrossRef
4.
5.
Westhovens R, Van der Elst K, Matthys A, Tran M, Gilloteau I. Sleep problems in patients with rheumatoid arthritis. J Rheumatol. 2014;41:31–40.CrossRefPubMed
6.
Maurer M, Weller K, Bindslev-Jensen C, Giménez-Arnau A, Bousquet PJ, Bousquet J, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011;66:317–30.CrossRefPubMed
7.
Baiardini I, Giardini A, Pasquali M, Dignetti P, Guerra L, Specchia C, et al. Quality of life and patients’ satisfaction in chronic urticaria and respiratory allergy. Allergy. 2003;58:621–3.CrossRefPubMed
8.
Grob JJ, Revuz J, Ortonne JP, Auquier P, Lorette G. Comparative study of the impact of chronic urticaria, psoriasis and atopic dermatitis on the quality of life. Br J Dermatol. 2005;152:289–95.CrossRefPubMed
9.
Maurer M, Ortonne J-P, Zuberbier T. Chronic urticaria: an internet survey of health behaviours, symptom patterns and treatment needs in European adult patients. Br J Dermatol. 2009;160:633–41.CrossRefPubMed
10.
O’Donnell BF, Lawlor F, Simpson J, Morgan M, Greaves MW. The impact of chronic urticaria on the quality of life. Br J Dermatol. 1997;136:197–201.CrossRefPubMed
11.
Yosipovitch G, Ansari N, Goon A, Chan YH, Goh CL. Clinical characteristics of pruritus in chronic idiopathic urticaria. Br J Dermatol. 2002;147:32–6.CrossRefPubMed
12.
Vietri J, Turner SJ, Tian H, Isherwood G, Balp MM, Gabriel S. Effect of chronic urticaria on US patients: analysis of the National Health and Wellness Survey. Ann Allergy Asthma Immunol. 2015;115:306–11.CrossRefPubMed
13.
14.
Kaplan A, Ledford D, Ashby M, Canvin J, Zazzali JL, Conner E, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013;132:101–9.CrossRefPubMed
15.
Maurer M, Rosén K, Hsieh H-J, Saini S, Grattan C, Gimenéz-Arnau A, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013;368:924–35.CrossRefPubMed
16.
Saini SS, Bindslev-Jensen C, Maurer M, Grob J-J, Basken EB, Bradley MS, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015;135:925.CrossRefPubMed
17.
Zuberbier T, Aberer W, Asero R, Bindslev-Jensen C, Brzoza Z, Canonica GW, et al. The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69:868–87.CrossRefPubMed
18.
Mathias SD, Dreskin SC, Kaplan A, Saini SS, Spector S, Rosén KE. Development of a daily diary for patients with chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2010;105:142–8.CrossRefPubMed
19.
Hays R, Stewart A. Sleep measures. In: Stewart A, Ware J, editors. Measuring functioning and well-being: the Medical Outcomes Study approach. Durham: Duke University Press; 1992. p. 235–9.
20.
Baiardini I, Pasquali M, Braido F, Fumagalli F, Guerra L, Compalati E, et al. A new tool to evaluate the impact of chronic urticaria on quality of life: Chronic Urticaria Quality of Life Questionnaire (CU-QoL). Allergy. 2005;60:1073–8.CrossRefPubMed
21.
Mathias SD, Tschosik EA, Zazzali JL. Adaptation and validation of the Urticaria Patient Daily Diary for adolescents. Allergy Asthma Proc. 2012;33:186–90.CrossRefPubMed
22.
Viala-Danten M, Martin S, Guillemin I, Hays RD. Evaluation of the reliability and validity of the Medical Outcomes Study Sleep Scale in patients with painful diabetic peripheral neuropathy during an international clinical trial. Health Qual Life Outcomes. 2008;6:113.CrossRefPubMedPubMedCentral
23.
Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical Outcomes Study Sleep measure. Sleep Med. 2005;6:41–4.CrossRefPubMed
24.
Stull DE. Analyzing growth and change: latent variable growth curve modeling with an application to clinical trials. Qual Life Res. 2008;17:47–59.CrossRefPubMed
25.
26.
Beltrani V. Clinical features of atopic dermatitis. Immunol Allergy Clin N Am. 2002;22:25–42.CrossRef
27.
Kelsay K. Management of sleep disturbance associated with atopic dermatitis. J Allergy Clin Immunol. 2006;118:198–201.CrossRefPubMed
28.
Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008;4:487–504.PubMedPubMedCentral
29.
Asero R. Chronic unremitting urticaria: is the use of antihistamines above the licensed dose effective? A preliminary study of cetirizine at licensed and above-licensed doses. Clin Exp Dermatol. 2007;32:34–8.CrossRefPubMed
30.
Staevska M, Popov TA, Kralimarkova T, Lazarova C, Kraeva S, Popova D, et al. The effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult-to-treat urticaria. J Allergy Clin Immunol. 2010;125:676–82.CrossRefPubMed
31.
Stull DE, McBride D, Houghton K, Finlay AY, Gnanasakthy A, Balp MM. Assessing changes in chronic spontaneous/idiopathic urticaria: comparisons of patient-reported outcomes using latent growth modeling. Adv Ther. 2016;33:214–24.CrossRefPubMedPubMedCentral
Metadata
Title
Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies
Authors
Ana M. Gimenéz-Arnau
Sheldon Spector
Evgeniya Antonova
Benjamin Trzaskoma
Karin Rosén
Theodore A. Omachi
Donald Stull
Maria-Magdalena Balp
Thomas Murphy
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Clinical and Translational Allergy / Issue 1/2016
Electronic ISSN: 2045-7022
DOI
https://doi.org/10.1186/s13601-016-0120-0

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