Omalizumab in patients with chronic spontaneous urticaria: a systematic review and GRADE assessment

Summary Chronic spontaneous urticaria (CSU) is characterized by the occurrence of hives, angio‐oedema or both for a period of at least 6 weeks. Many patients remain symptomatic despite treatment with H1 antihistamines, even at higher doses. This systematic review assessed the quality of the evidence...

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Bibliographic Details
Published in:British journal of dermatology (1951) 2015-08, Vol.173 (2), p.404-415
Main Authors: Urgert, M.C., van den Elzen, M.T., Knulst, A.C., Fedorowicz, Z., van Zuuren, E.J.
Format: Article
Language:English
Subjects:
Anti-Allergic Agents - therapeutic use
Antihistamines
Chronic Disease
Clinical trials
Edema
Humans
Immunoglobulin E
Immunotherapy
Monoclonal antibodies
Omalizumab - therapeutic use
Quality of Life
Randomized Controlled Trials as Topic
Statistical analysis
Systematic review
Treatment Outcome
Urticaria
Urticaria - drug therapy
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Summary:Summary Chronic spontaneous urticaria (CSU) is characterized by the occurrence of hives, angio‐oedema or both for a period of at least 6 weeks. Many patients remain symptomatic despite treatment with H1 antihistamines, even at higher doses. This systematic review assessed the quality of the evidence for the effects of omalizumab as treatment in patients with CSU. We searched PubMed, the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials up to 7 August 2014. Three review authors independently carried out study selection, risk of bias assessment and data extraction. Two review authors analysed the data. Five randomized controlled trials (RCTs), which included 1116 participants, were evaluated. All the RCTs were judged as having a low risk of bias. There was a statistically significant improvement in measures of disease activity and quality of life following treatment with omalizumab when compared with placebo [mean difference (MD) −11·58, 95% confidence interval (CI) −13·39 to −9·77 and MD −13·12, 95% CI −16·30 to −9·95, respectively]. Complete response and partial response were more frequent after treatment with omalizumab [risk ratio (RR) 6·44, 95% CI 3·95–10·49 and RR 4·08, 95% CI 2·98–5·60, respectively]. There was no difference in the proportion of participants reporting adverse events between the omalizumab and placebo treatment groups (RR 1·05, 95% CI 0·96–1·16). There was high‐quality evidence to support the effectiveness and safety of omalizumab 300 mg per month for the treatment of CSU for up to 6 months. What's already known about this topic? Despite available treatment options many patients with chronic spontaneous urticaria remain symptomatic The recently published EAACI/GA2LEN/EDF/WAO guideline recommends omalizumab as ‘add‐on’ therapy to second‐generation H1 antihistamines as third line treatment What does this study add? A detailed GRADE assessment indicated high‐quality evidence for the effectiveness and safety of omalizumab 300 mg per month for up to 6 months
ISSN:0007-0963
1365-2133
DOI:10.1111/bjd.13845