A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H 1-antihistamine-refractory chronic idiopathic urticaria

Sarbjit S Saini, Karin E. Rosen, Hsin Ju Hsieh, Dennis A. Wong, Edward Conner, Allen Kaplan, Sheldon Spector, Marcus Maurer

Research output: Contribution to journalArticle

Abstract

Background: Proof-of-concept studies with omalizumab in patients with chronic idiopathic urticaria (CIU) have shown significant decreases in mean urticaria activity scores (UASs). Objective: We sought to evaluate the efficacy and safety of omalizumab in patients with CIU who remain symptomatic despite concomitant H 1-antihistamine therapy. Methods: This phase II, prospective, double-blind, placebo-controlled, dose-ranging study investigated omalizumab in patients aged 12 to 75 years in the United States and 18 to 75 years in Germany with a UAS over 7 days (UAS7) of 12 or greater despite antihistamine therapy. Patients were randomized 1:1:1:1 to receive a single subcutaneous dose of 75, 300, or 600 mg of omalizumab or placebo added to a stable dose of H 1-antihistamine. The primary efficacy outcome was change from baseline to week 4 in UAS7. Patients were followed for an additional 12 weeks to monitor safety. Results: Ninety patients from the United States or Germany were enrolled. Both the 300-mg omalizumab group (-19.9 vs -6.9, P 1-antihistamines.

Original languageEnglish (US)
JournalThe Journal of Allergy and Clinical Immunology
Volume128
Issue number3
DOIs
StatePublished - Sep 2011

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Histamine Antagonists
Urticaria
Placebos
Germany
Safety
Omalizumab
Therapeutics

Keywords

  • Chronic idiopathic urticaria
  • chronic spontaneous urticaria
  • dose ranging
  • H -antihistamine
  • hive
  • itch
  • omalizumab
  • urticaria activity score

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H 1-antihistamine-refractory chronic idiopathic urticaria. / Saini, Sarbjit S; Rosen, Karin E.; Hsieh, Hsin Ju; Wong, Dennis A.; Conner, Edward; Kaplan, Allen; Spector, Sheldon; Maurer, Marcus.

In: The Journal of Allergy and Clinical Immunology, Vol. 128, No. 3, 09.2011.

Research output: Contribution to journalArticle

Saini, Sarbjit S ; Rosen, Karin E. ; Hsieh, Hsin Ju ; Wong, Dennis A. ; Conner, Edward ; Kaplan, Allen ; Spector, Sheldon ; Maurer, Marcus. / A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H 1-antihistamine-refractory chronic idiopathic urticaria. In: The Journal of Allergy and Clinical Immunology. 2011 ; Vol. 128, No. 3.
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