Timing and duration of omalizumab response in patients with chronic idiopathic/spontaneous urticaria - 05/02/16
, Benjamin Trzaskoma, MS d, Karina Raimundo, MS d, Karin Rosén, MD, PhD d, Theodore A. Omachi, MD, MBA d, Sam Khalil, PhD e, James L. Zazzali, PhD, MPH dAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : Omalizumab, chronic idiopathic urticaria, chronic spontaneous urticaria, responder analysis, complete response, well-controlled urticaria
Abbreviations used : CIU, CSU, LTRA, UAS, UAS7
Plan
| 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. |
Vol 137 - N° 2
P. 474-481 - février 2016 Retour au numéro
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