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Original Investigation
November 14, 2018

Benefits and Harms of Omalizumab Treatment in Adolescent and Adult Patients With Chronic Idiopathic (Spontaneous) UrticariaA Meta-analysis of “Real-world” Evidence

Author Affiliations
  • 1Department of Dermatology, Rush University Medical Center, Chicago, Illinois
  • 2Division of Immunology, Department of Internal Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio
  • 3US Health Economics & Outcomes Research, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
  • 4Respiratory Medical Unit, US Clinical Development and Medical Affairs, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
  • 5Matrix45, Tucson, Arizona
  • 6Department of Public Health, University of Basel, Basel, Switzerland
  • 7Associate Editor for Quantitative Methods, JAMA Dermatology
  • 8Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, Arizona
  • 9Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, Arizona
  • 10Boston College Connell School of Nursing, Chestnut Hill, Massachusetts
JAMA Dermatol. Published online November 14, 2018. doi:10.1001/jamadermatol.2018.3447
Key Points

Question  What is known about the benefits and harms of omalizumab as used in the real-world clinical management of chronic idiopathic urticaria (also known as chronic spontaneous urticaria)?

Findings  In this meta-analysis of 67 published reports on real-world effectiveness, omalizumab therapy was associated with an average 25.6-point improvement in weekly Urticaria Activity Score (vs a 14.9 to 22.1 point improvement reported in clinical trials), a 4.7 point improvement in Urticaria Activity Score, a complete response rate of 72.2%, a partial response rate of 17.8%, and an average adverse event rate of 4.0% (vs 2.9%-8.0% reported in clinical trials).

Meaning  Benefits and safety of omalizumab in the real-world treatment of chronic idiopathic urticaria meet or exceed the results gleaned from clinical trials.

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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