Atopic dermatitis and skin disease
Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria

https://doi.org/10.1016/j.jaci.2015.08.023Get rights and content
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Background

Few data are available that describe response patterns in patients with chronic idiopathic urticaria (CIU)/chronic spontaneous urticaria (CSU) treated with omalizumab.

Objective

We sought to describe response patterns by using data from the 3 pivotal omalizumab CIU/CSU trials.

Methods

Every 4 weeks, randomized patients received dosing with placebo or 75, 150, or 300 mg of omalizumab (ASTERIA I: n = 318, 24 weeks; ASTERIA II: n = 322, 12 weeks) or placebo or 300 mg of omalizumab (GLACIAL: n = 335, 24 weeks). Response was defined as well-controlled urticaria (weekly Urticaria Activity Score [UAS7] ≤ 6) or complete response (UAS7 = 0).

Results

Response rates were dose dependent and highest with 300 mg of omalizumab. Some patients responded early (before week 4). At week 12, a higher proportion of patients treated with 300 mg of omalizumab reported a UAS7 ≤ 6 (26.0% [75 mg of omalizumab], 40.0% [150 mg of omalizumab], 51.9% [300 mg of omalizumab], and 11.3% [placebo] for ASTERIA I; 26.8% [75 mg of omalizumab], 42.7% [150 mg of omalizumab], 65.8% [300 mg of omalizumab], and 19.0% [placebo] for ASTERIA II; and 52.4% [300 mg of omalizumab] and 12.0% [placebo] for GLACIAL) or a UAS7 = 0 (11.7% [75 mg of omalizumab], 15.0% [150 mg of omalizumab], 35.8% [300 mg of omalizumab], and 8.8% [placebo] for ASTERIA I; 15.9% [75 mg of omalizumab], 22.0% [150 mg of omalizumab], 44.3% [300 mg of omalizumab], and 5.1% [placebo] for ASTERIA II; and 33.7% [300 mg of omalizumab] and 4.8% [placebo] for GLACIAL). In patients receiving 300 mg of omalizumab with 24 weeks of treatment, median time to achieve a UAS7 ≤ 6 was 6 weeks (ASTERIA I and GLACIAL) and median time to achieve a UAS7 = 0 was 12 or 13 weeks (ASTERIA I and GLACIAL, respectively). Some patients who achieved well-controlled urticaria or complete response sustained response throughout the treatment period.

Conclusion

Benefits of omalizumab treatment were evident early (before week 4) in some patients and persisted to week 24. Use of 300 mg of omalizumab demonstrated best results in controlling CIU/CSU symptoms.

Key words

Omalizumab
chronic idiopathic urticaria
chronic spontaneous urticaria
responder analysis
complete response
well-controlled urticaria

Abbreviations used

CIU
Chronic idiopathic urticaria
CSU
Chronic spontaneous urticaria
LTRA
Leukotriene receptor antagonist
UAS
Urticaria Activity Score
UAS7
Weekly Urticaria Activity Score

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The funding for ASTERIA I, ASTERIA II, and GLACIAL, as well as this analysis, was provided by Genentech, Inc, South San Francisco, California, and Novartis Pharma AG, Basel, Switzerland. Funding for medical writing support for this manuscript was provided by Genentech, Inc and Novartis Pharmaceuticals Corporation.

Disclosure of potential conflict of interest: A. Kaplan reports having received grants from Dyax, Genentech, Inc, and Shire; personal fees for speaker's bureau activities from Dyax and Shire; and personal fees for consulting activities from CSL Behring and Sanofi-Aventis. M. Ferrer has received research support from Novartis; has received consultancy fees from FAES, Genentech, Inc, and Novartis; and has received lecture fees from MSD. J. A. Bernstein has received research support, consultancy fees, and travel support from Novartis/Genentech, Inc and is a member of the American Academy of Allergy, Asthma & Immunology's Board of Directors. E. Antonova and K. Raimundo are employed by Genentech, Inc. B. Trzaskoma is employed by and has stock/stock options in Genentech, Inc. K. Rosén and J. L. Zazzali are employed by and have stock/stock options in Roche/Genentech, Inc. T. A Omachi was an employee of Roche/Genentech, Inc during the conduct of the study. S. Khalil reports was an employee of Novartis during the conduct of the study.