Scientific publications

Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria

Kaplan A (1), Ferrer M (2), Bernstein JA (3), Antonova E (4), Trzaskoma B (5), Raimundo K (5), Rosén K (5), Omachi TA (5), Khalil S (6), Zazzali JL (5).
(1) Medical University of South Carolina, Charleston, SC.
(2) Clinica Universidad de Navarra, Universidad de Navarra, Instituto De Investigación sanitaria de Navarra (IDISNA) Pamplona, Pamplona, Spain.
(3) University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio.
(4) Genentech, Inc, South San Francisco, Calif.
(5) Genentech, Inc, South San Francisco, Calif.
(6) Novartis AG, Basel, Switzerland.

Magazine: The Journal of Allergy Clinical Immunology

Date: Feb 1, 2016

Allergology and Immunology Department

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.

CITATION  J Allergy Clin Immunol. 2016 Feb;137(2):474-81. doi: 10.1016/j.jaci.2015.08.023. Epub 2015 Oct 21.

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