NDLI: A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Saini, Sarbjit Rosen, Karin E. Hsieh, Hsin-Ju Wong, Dennis A. Conner, Edward Kaplan, Allen Spector, Sheldon Maurer, Marcus
Spatial Coverage	United States Germany
Description	Country affiliation: United States Author Affiliation: Saini S ( Johns Hopkins Asthma and Allergy Center, Baltimore, MD 21224, USA. ssaini@jhmi.edu)
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 < .001) and the 600-mg omalizumab group (-14.6 vs -6.9, P = .047) showed greater improvement versus the placebo group in UAS7. No meaningful difference was observed for the 75-mg omalizumab group. Similar results were seen for key secondary end points of weekly hive and itch scores. Onset of effect occurred after 1 to 2 weeks. Omalizumab was well tolerated, and the incidence of adverse events was similar across treatment groups. CONCLUSION: This study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU in patients who are symptomatic despite treatment with H(1)-antihistamines.
File Format	HTM / HTML
ISSN	00916749
e-ISSN	10976825
Journal	Journal of Allergy and Clinical Immunology
Issue Number	3
Volume Number	128
Language	English
Publisher	Elsevier
Publisher Date	2011-09-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline Immunology Anti-allergic Agents Administration & Dosage Antibodies, Anti-idiotypic Antibodies, Monoclonal Histamine H1 Antagonists Urticaria Drug Therapy Adolescent Adverse Effects Therapeutic Use Antibodies, Monoclonal, Humanized Chronic Disease Dose-response Relationship, Drug Double-blind Method Drug Therapy, Combination Germany Omalizumab Prospective Studies Physiopathology Clinical Trial, Phase Ii Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Immunology and Allergy Immunology

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