title: A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Johns Hopkins Asthma and Allergy Center, Baltimore, MD 21224, USA. ssaini@jhmi.edu
authors.forename: Sarbjit
authors.initials: S
authors.lastname: Saini
authors.forename: Karin E
authors.initials: KE
authors.lastname: Rosen
authors.forename: Hsin-Ju
authors.initials: HJ
authors.lastname: Hsieh
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Wong
authors.forename: Edward
authors.initials: E
authors.lastname: Conner
authors.forename: Allen
authors.initials: A
authors.lastname: Kaplan
authors.forename: Sheldon
authors.initials: S
authors.lastname: Spector
authors.forename: Marcus
authors.initials: M
authors.lastname: Maurer
mesh_terms: D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000888:Antibodies, Anti-Idiotypic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D002648:Child; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005858:Germany; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011446:Prospective Studies; D016896:Treatment Outcome; D014481:United States; D014581:Urticaria / Q000188:drug therapy* / Q000503:physiopathology; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D006634:Histamine H1 Antagonists; D000069444:Omalizumab