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Review
. 2019 Jan 1;155(1):29-38.
doi: 10.1001/jamadermatol.2018.3447.

Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of "Real-world" Evidence

Michael D Tharp  1 , Jonathan A Bernstein  2 , Abhishek Kavati  3 , Benjamin Ortiz  4 , Karen MacDonald  5 , Kris Denhaerynck  5   6 , Ivo Abraham  5   7   8   9 , Christopher S Lee  5   10
Affiliations
Review

Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) Urticaria: A Meta-analysis of "Real-world" Evidence

Michael D Tharp et al. JAMA Dermatol. .

Abstract

Importance: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) (also known as chronic spontaneous urticaria) in adolescents and adults with persistent hives not controlled with antihistamines. The effectiveness of omalizumab in the real-world management of CIU is largely unknown.

Objective: To quantitatively synthesize what is known about the benefits and harms of omalizumab in the real-world clinical management of CIU regarding urticaria activity, treatment response, and adverse events.

Data sources: Published observational studies (January 1, 2006, to January 1, 2018) and scientific abstracts on the effectiveness of omalizumab in CIU were identified using PubMed, Embase, Web of Science, and Cochrane search engines; references were searched to identify additional studies.

Study selection: Included studies were observational in design and included at least 1 outcome in common with other studies and at a concurrent time point of exposure to omalizumab. A total of 67 articles (35.2% of those screened) were included in the analysis.

Data extraction and synthesis: PRISMA and MOOSE guidelines were followed; independent selection and data extraction were completed by 2 observers. Random-effects meta-analyses were performed.

Main outcomes and measures: Main outcomes were change in weekly Urticaria Activity Score (UAS7; range, 0-42), change in Urticaria Activity Score (UAS; range 0-6) (higher score indicating worse outcome in both scales), complete and partial response rates (percentages), and adverse event rate (percentage).

Results: Omalizumab therapy was associated with an improvement in UAS7 scores (-25.6 points, 95% CI, -28.2 to -23.0; P < .001; 15 studies, 294 patients), an improvement in UAS scores (-4.7 points, 95% CI, -5.0 to -4.4, P < .001; 10 studies, 1158 patients), an average complete response rate of 72.2% (95% CI, 66.1%-78.3%; P < .001; 45 studies, 1158 patients) with an additional average partial response rate of 17.8% (95% CI, 11.7%-23.9%; P < .001; 37 studies, 908 patients), and an average adverse event rate of 4.0% (95% CI, 1.0%-7.0%; P < .001; any level of severity, 47 studies, 1314 patients).

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

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Tharp served as a consultant to Novartis Pharmaceuticals Corporation for work on this study. Dr Bernstein served as a consultant to Novartis for work on this study; he is affiliated with Bernstein Clinical Research Center, LLC, which was under contract with Novartis as a primary investigator to conduct clinical research outside of the submitted work; he has received speaker fees from Novartis as well as consulting fees from Genentech; and he is an author on the Joint Task Force for Practice Parameters for Urticaria guideline and the GALEN international guideline for urticaria. Drs Kavati and Ortiz are employees and stockholders of Novartis. Drs MacDonald, Denhaerynck, Abraham, and Lee are affiliated with Matrix45; by company policy, they are prohibited from owning equity in client organizations (except through mutual funds or other independently administered collective investment instruments) or contracting independently with client organizations; Matrix45 provides services similar to those described in this article to other biopharmaceutical companies on a nonexclusivity basis. No other disclosures are reported.

Figures

Figure 1.
Figure 1.. Study Inclusion Flowchart
Figure 2.
Figure 2.. Change in Weekly Urticaria Activity Score (UAS7) Following Omalizumab Treatment
This forest plot represents the mean (95% CI) change in UAS7 results (squares [horizontal lines]) within individual studies. The size of each square represents the weight, by random effects analysis, of the contribution of each study; exact percentage weights are listed in the Weight column. The overall meta-analytic summary mean (95% CI) is represented by the vertical line (diamond), and the estimated predictive interval, by the solid horizontal lines extending from this diamond.
Figure 3.
Figure 3.. Urticaria Complete Response Rate Following Omalizumab Treatment
This forest plot represents the mean (95% CI) complete response rate (squares [horizontal lines]) found within individual studies. The size of each square represents the weight, by random effects analysis, of the contribution of each study; exact percentage weights are listed in the Weight column. The overall meta-analytic summary mean (95% CI) is represented by the vertical line (diamond), and the estimated predictive interval, by the solid horizontal lines extending from this diamond.
Figure 4.
Figure 4.. Adverse Event Rate in Response to Omalizumab in Urticaria
This forest plot represents the mean (95% CI) adverse event rate (squares [horizontal lines]) found within individual studies. The size of each square represents the weight, by random effects analysis, of the contribution of each study; exact percentage weights are listed in the Weight column. The overall meta-analytic summary mean (95% CI) is represented by the vertical line (diamond), and the estimated predictive interval, by the solid horizontal lines extending from this diamond.
See this image and copyright information in PMC

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