title: Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies.
abstract: Angioedema, present in some patients with chronic idiopathic/spontaneous urticaria (CIU/CSU), may have a negative effect on patient quality of life.
  
  
  
  To describe patient-reported angioedema and its management in the pivotal omalizumab studies (ASTERIA I, ASTERIA II, GLACIAL).
  
  
  
  Enrolled patients with CIU/CSU remained symptomatic despite treatment with histamine1(H1)-antihistamines at licensed doses (ASTERIA I, ASTERIA II) or H1-antihistamines at up to 4 times the approved dose plus H2-antihistamines and/or a leukotriene receptor antagonist (GLACIAL). All studies administered omalizumab (75, 150, or 300 mg in ASTERIA I and ASTERIA II; 300 mg in GLACIAL) or placebo subcutaneously every 4 weeks for at least 12 weeks. Urticaria Patient Daily Diary entries were completed by patients and summarized.
  
  
  
  At baseline, angioedema prevalence was higher in GLACIAL (53.1%) than in ASTERIA I (47.5%) or ASTERIA II (40.7%). The mean proportion of angioedema-free days during weeks 4 to 12 was greater for patients treated with 300 mg of omalizumab than placebo in ASTERIA I (96.1% vs 88.2%, P < .001), ASTERIA II (95.5% vs 89.2%, P < .001), and GLACIAL (91.0% vs 88.7%, P = .006). Most patient-reported angioedema was managed by low-intensity interventions (doing nothing or taking medication).
  
  
  
  Treatment with 300 mg of omalizumab was efficacious in reducing patient-reported angioedema. Low-intensity interventions were generally used to manage angioedema episodes.
  
  
  
  clinicaltrials.gov Identifiers: NCT01287117 (ASTERIA I), NCT01292473 (ASTERIA II), and NCT01264939 (GLACIAL).
authors.affiliation: Genentech Inc, South San Francisco, California.
authors.forename: James L
authors.initials: JL
authors.lastname: Zazzali
authors.affiliation: Department of Medicine, Division of Pulmonary and Critical Care and Allergy and Clinical Immunology, University of South Carolina, Charleston, South Carolina.
authors.forename: Allen
authors.initials: A
authors.lastname: Kaplan
authors.affiliation: Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Maurer
authors.affiliation: Genentech Inc, South San Francisco, California.
authors.forename: Karina
authors.initials: K
authors.lastname: Raimundo
authors.affiliation: Genentech Inc, South San Francisco, California.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Trzaskoma
authors.affiliation: Genentech Inc, South San Francisco, California.
authors.forename: Paul G
authors.initials: PG
authors.lastname: Solari
authors.affiliation: Genentech Inc, South San Francisco, California. Electronic address: antonova.evgeniya@gene.com.
authors.forename: Evgeniya
authors.initials: E
authors.lastname: Antonova
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: Meryl
authors.initials: M
authors.lastname: Mendelson
authors.affiliation: Genentech Inc, South San Francisco, California.
authors.forename: Karin E
authors.initials: KE
authors.lastname: Rosén
mesh_terms: D000328:Adult; D000799:Angioedema / Q000188:drug therapy*; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use; D006635:Histamine H2 Antagonists / Q000627:therapeutic use; D006801:Humans; D020024:Leukotriene Antagonists / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000627:therapeutic use*; D016896:Treatment Outcome; D014581:Urticaria / Q000188:drug therapy*
chemical_list: D018926:Anti-Allergic Agents; D006634:Histamine H1 Antagonists; D006635:Histamine H2 Antagonists; D020024:Leukotriene Antagonists; D000069444:Omalizumab