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

详细信息    查看全文

• 作者：Allen Kaplan ; MD^a ; Marta Ferrer ; MD ; PhD^b ; Jonathan A. Bernstein ; MD^c ; Evgeniya Antonova ; MS ; PhD^d ; ^{antonova.evgeniya@gene.com" class="auth_mail" title="E-mail the corresponding author} ; Benjamin Trzaskoma ; MS^d ; Karina Raimundo ; MS^d ; Karin Rosé ; n ; MD ; PhD^d ; Theodore A. Omachi ; MD ; MBA^d ; Sam Khalil ; PhD^e ; James L. Zazzali ; PhD ; MPH^d
• 关键词：Omalizumab ; chronic idiopathic urticaria ; chronic spontaneous urticaria ; responder analysis ; complete response ; well-controlled urticaria
• 刊名：Journal of Allergy and Clinical Immunology
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：137
• 期：2
• 页码：474-481
• 全文大小：436 K

文摘

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.