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 H 1 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 ( RCT s), which included 1116 participants, were evaluated. All the RCT s 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.