title: Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria.
abstract: BACKGROUND
  Many patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H-antihistamines, even at high doses. In phase 2 trials, omalizumab, an anti-IgE monoclonal antibody [corrected] that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients.
  
  
  METHODS
  In this phase 3, multicenter, randomized, double-blind study, we evaluated the efficacy and safety of omalizumab in patients with moderate-to-severe chronic idiopathic urticaria who remained symptomatic despite H-antihistamine therapy (licensed doses). We randomly assigned 323 patients to receive three subcutaneous injections, spaced 4 weeks apart, of omalizumab at doses of 75 mg, 150 mg, or 300 mg or placebo, followed by a 16-week observation period. The primary efficacy outcome was the change from baseline in a weekly itch-severity score (ranging from 0 to 21, with higher scores indicating more severe itching).
  
  
  RESULTS
  The baseline weekly itch-severity score was approximately 14 in all four study groups. At week 12, the mean (±SD) change from baseline in the weekly itch-severity score was -5.1±5.6 in the placebo group, -5.9±6.5 in the 75-mg group (P=0.46), -8.1±6.4 in the 150-mg group (P=0.001), and -9.8±6.0 in the 300-mg group (P<0.001). Most prespecified secondary outcomes at week 12 showed similar dose-dependent effects. The frequency of adverse events was similar across groups. The frequency of serious adverse events was low, although the rate was higher in the 300-mg group (6%) than in the placebo group (3%) or in either the 75-mg or 150-mg group (1% for each).
  
  
  CONCLUSIONS
  Omalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.).
authors: Department of Dermatology and Allergy, Charité-Universitätsmedizin, Berlin.
authors: Marcus
authors: M
authors: Maurer
authors: Karin
authors: K
authors: Rosén
authors: Hsin-Ju
authors: HJ
authors: Hsieh
authors: Sarbjit
authors: S
authors: Saini
authors: Clive
authors: C
authors: Grattan
authors: Ana
authors: A
authors: Gimenéz-Arnau
authors: Sunil
authors: S
authors: Agarwal
authors: Ramona
authors: R
authors: Doyle
authors: Janice
authors: J
authors: Canvin
authors: Allen
authors: A
authors: Kaplan
authors: Thomas
authors: T
authors: Casale
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D011537:Pruritus / Q000188:drug therapy* / Q000209:etiology; D012720:Severity of Illness Index; D014581:Urticaria / Q000150:complications / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab