Efficacy of Urticaria Therapy Examined in Real-World Study


Omalizumab (Xolair) was safe and effective for patients with chronic idiopathic urticaria (CIU), according to the findings of a recent study. The study assessed real-world data on omalizumab use for the treatment of CIU to determine its benefits and harm among patients in a clinical setting.

Using Pubmed, Embase, Web of Science, and Cochrane databases, the researchers identified 67 observational studies that shared at least 1 main outcome and were published from January 1, 2006 to January 1, 2018. The main outcomes included changes in weekly Urticaria Activity Scores (UAS7), changes in Urticaria Activity Scores (UAS), complete and partial response rates, and adverse event rates.

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Overall, omalizumab was associated with improvements in UAS7 scores in 15 studies that included a total of 294 participants (−25.6 points; 95% CI, −28.2 to −23.0; P < .001) and in UAS scores in 10 studies that included a total of 1158 participants (−4.7 points; 95% CI, −5.0 to −4.4, P < .001).

The average complete response rate calculated from 45 studies with 1158 participants was 72% (95% CI, 66.1%-78.3%; P < .001), and the average partial response rate calculated from 37 studies with 908 participants was 17.8% (95% CI, 11.7%-23.9%; P < .001).

In addition, the average adverse event rate was 4% (95% CI, 1.0%-7.0%; P < .001), which was determined using data from 47 studies with 1314 participants.

“Benefits and safety of omalizumab in the real-world treatment of CIU meet or exceed results gleaned from clinical trials,” the researchers concluded. “These real-world data on omalizumab in CIU may help inform both clinical treatment expectations and policy decision making.” 


Tharp MD, Bernstein JA, Kavati A, et al. Benefits and harms of omalizumab treatment in adolescent and adult patients with chronic idiopathic (spontaneous) urticaria: A meta-analysis of “real-world” evidence [pubslihed online November 14, 2018]. JAMA Dermatol. doi:10.1001/jamadermatol.2018.3447