Real-world treatment patterns and outcomes of omalizumab use in patients with chronic idiopathic urticaria

Abstract

Objective: To examine treatment patterns, treatment response, and demographic and clinical characteristics of patients with chronic idiopathic urticaria (CIU) newly initiated on omalizumab therapy in real-world practice in the US.

Methods: This retrospective observational cohort study used US claims data from the HealthCore Integrated Research Database (HIRD^®) augmented with medical record data to identify CIU patients newly-treated with omalizumab (≥4 omalizumab claims within 6 months of initial claim; index date = first omalizumab claim date) between March 21, 2014 and October 31, 2015 and with ≥6 months pre- and ≥12 months post-index health plan eligibility. Study outcomes were captured from medical records for up to 12 months pre-index and up to 24 months post-index. Descriptive statistics were reported.

Results: This study consisted of 88 patients with a mean (SD) age of 43.4 (± 13.46) years, 68.2% were female, and 36 patients had ≥18 months post-index eligibility. Among 69 patients with documented index dose, 75.4% received omalizumab 300 mg and 69.6% remained on index dose throughout follow-up. For 52 patients with documented index dosing frequency, 96.2% had every 4-week dosing frequency. Among 86 patients with omalizumab documentation, 83.7% reported CIU improvement after omalizumab initiation and 24.4% discontinued omalizumab. For all patients, the proportion using oral corticosteroids (OCS) decreased pre- to post-index (52.3% vs 39.8%). Similar results were observed for patients with ≥18 months post-index eligibility.

Conclusions: In this real-world analysis, the majority of patients remained on omalizumab for ≥12 months, and had a positive response. OCS use decreased following omalizumab initiation.

Keywords:

• Chronic idiopathic urticaria
• treatment patterns
• health outcomes
• omalizumab
• claims and medical record study

Transparency

Declaration of funding

Funding for this study was provided by Novartis Pharmaceuticals Corporation. Novartis was involved with data interpretation, drafting and reviewing the manuscript, and the decision to publish the findings of this study.

Declaration of financial/other interests

Liya Wang, Xuehua Ke, Debra Wertz, Qing Huang, Vincent J. Willey, and Judith J. Stephenson are employees of HealthCore, Inc., a wholly owned subsidiary of Anthem, Inc. Abhishek Kavati, Benjamin Ortiz, and Brandee Paknis are employees of Novartis Pharmaceuticals Corporation. Jonathan A. Bernstein is affiliated with Bernstein Clinical Research Center, LLC, under contract with Novartis Pharmaceuticals Corporation to provide consulting services to the study, and serves as an investigator, speaker, and consultant for Novartis Pharmaceuticals Corporation and Genentech, Inc. Lisa A. Beck is an employee of University of Rochester Medical Center (URMC), under contract with Novartis Pharmaceuticals Corporation to provide consulting services to the study, and has the following relationships: Abbvie Inc. – research grant to URMC, consultant; Array Biopharma Inc. – consultant; Celgene Corporation – consultant; Eli Lilly and Co. – consultant; Genentech, Inc. – research grant to URMC, consultant; Hoffman-LaRoche AG – consultant; Janssen Pharmaceuticals, Inc. – consultant; Regeneron Pharmaceuticals, Inc. – research grant to URMC, consultant; Medtronic – stock owner; Pfizer Inc. – stock owner. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. One of the peer reviewers on this manuscript has participated on advisory boards for Genentech/Novartis and has lectured on chronic urticaria for Novartis. Each of the reviewers have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.

Acknowledgments

Cheryl Jones, HealthCore Inc., provided writing and editorial support for this manuscript.