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Real-world use of omalizumab in patients with chronic idiopathic/spontaneous urticaria in the United States

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Omalizumab was approved for the treatment of chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) in the United States in March 2014.


This study sought to describe real-world omalizumab use, in the United States, in a large cohort of patients with CIU/CSU.


Patients with CIU/CSU (ages ≥12 years) initiated on omalizumab (index date) with ≥12 months of pre- and postindex data were identified in the an insurance claims data base (January 1, 2013, to July 31, 2016). Treatment patterns, including the dosing regimen and continuous use of omalizumab (no gaps for ≥60 days), were described during the 12-month postindex follow-up period.


A total of 1546 patients (mean ± standard deviation [SD] ages, 44 ± 14.5 years; 73.1% women) were identified. Most of the patients (84.5%) were initiated on omalizumab 300-mg dose; 90% maintained the initial dose, 7.5% had a dose increase, and 4.6% had a dose decrease. The mean ± SD omalizumab treatment duration was 9.1 ± 3.8 months, the mean ± SD number of omalizumab administrations was 8.3 ± 4.8, and the mean ± SD administration frequency was 44 ± 29 days. A proportion of the patients continuously treated with omalizumab for 6, 9, and 12 months was 67.3, 54.8, and 47.4%, respectively. Among the patients who discontinued omalizumab for ≥3 months (39.8%), 21% restarted the treatment after a mean ± SD of 4.4 ± 1.3 months. The proportion of patients who used other CIU/CSU-related medications decreased pre- to postindex (94.8 to 81.1%), with the highest decrease observed in oral corticosteroids (75.7 to 49.9%).


In this large real-world study, the majority of the patients with CIU/CSU were initiated on a 300-mg omalizumab dose and treated without titration up or down for 9 months on average. Most of the patients were continuously treated with omalizumab for ≥6 months, and one-fourth of the patients who discontinued treatment resumed it. Moreover, compared with baseline levels, the use of other CIU/CSU-related medications was lower after omalizumab initiation, with the most prominent decrease observed in oral corticosteroids.

Keywords: Chronic idiopathic urticaria; anti-IgE antibody; biologic; chronic spontaneous urticaria; claims study; clinical practice; omalizumab; patient characteristics; real-world study; treatment patterns

Document Type: Research Article

Affiliations: 1: From the Family Allergy and Asthma Care, Gaithersburg, Maryl 2: Atlantic Research Center, LLC, Ocean, New Jersey 3: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 4: Analysis Group, Montréal, Quebec, Canada 5: Novartis Pharma AG, Basel, Switzerl 6: Bernstein Clinical Research Center, Cincinnati, Ohio

Publication date: May 1, 2018

This article was made available online on February 19, 2018 as a Fast Track article with title: "Real-world use of omalizumab in patients with chronic idiopathic/spontaneous urticaria in the United States ".

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