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


CONCLUSIONS
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.
Medical University of South Carolina, Charleston, SC.
Allen
A
Kaplan
Clinica Universidad de Navarra, Universidad de Navarra, Instituto De Investigación sanitaria de Navarra (IDISNA) Pamplona, Pamplona, Spain.
Marta
M
Ferrer
University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio.
Jonathan A
JA
Bernstein
Genentech, Inc, South San Francisco, Calif. Electronic address: antonova.evgeniya@gene.com.
Evgeniya
E
Antonova
Genentech, Inc, South San Francisco, Calif.
Benjamin
B
Trzaskoma
Genentech, Inc, South San Francisco, Calif.
Karina
K
Raimundo
Genentech, Inc, South San Francisco, Calif.
Karin
K
Rosén
Genentech, Inc, South San Francisco, Calif.
Theodore A
TA
Omachi
Novartis AG, Basel, Switzerland.
Sam
S
Khalil
Genentech, Inc, South San Francisco, Calif.
James L
JL
Zazzali
D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000008:administration & dosage / Q000627:therapeutic use*; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014581:Urticaria / Q000175:diagnosis / Q000188:drug therapy*
D018926:Anti-Allergic Agents; D000069444:Omalizumab
Omalizumab; chronic idiopathic urticaria; chronic spontaneous urticaria; complete response; responder analysis; well-controlled urticaria