title: Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy.
abstract: BACKGROUND
  Data from the 3 omalizumab pivotal trials in patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) represent the largest database of patients reported to date with refractory disease (omalizumab, n = 733; placebo, n = 242).
  
  
  OBJECTIVE
  The objective of this study was to compare results from ASTERIA I and II, which included only approved doses of H1-antihistamine as background therapy based on regulatory authority requirements, to those from GLACIAL, which permitted higher doses of H1-antihistamines as well as other types of background therapy, in a post hoc analysis.
  
  
  METHODS
  Efficacy data from the placebo, omalizumab 150-mg, and omalizumab 300-mg treatment arms of ASTERIA I and II were pooled and analyzed (n = 162 and n = 160, respectively). The 300-mg treatment arm analyses were compared with the analysis of data from GLACIAL (n = 252) using analysis of covariance models. The key efficacy endpoint was change from baseline to week 12 in mean weekly itch severity score (ISS); other endpoints were also evaluated. Safety data were pooled from all 3 studies.
  
  
  RESULTS
  Mean ISS was significantly reduced from baseline at week 12 in the pooled ASTERIA I and II omalizumab 150- and 300-mg treatment arms and in the GLACIAL omalizumab 300-mg arm. The weekly ISS reduction magnitude at week 12 was similar between the omalizumab 300-mg groups in the ASTERIA I and II pooled and GLACIAL studies. Similar treatment effect sizes were observed across multiple endpoints. Omalizumab was well tolerated and the adverse-event profile was similar regardless of background therapy for CIU/CSU. The overall safety profile was generally consistent with omalizumab therapy in allergic asthma.
  
  
  CONCLUSIONS
  Omalizumab 300 mg was safe and effective in reducing CIU/CSU symptoms regardless of background therapy.
authors.affiliation: Department of Medicine, Division of Allergy and Immunology, University of South Florida, Tampa, Fla.
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Casale
authors.affiliation: Department of Internal Medicine and Division of Immunology/Allergy Section, University of Cincinnati, Cincinnati, Ohio.
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Bernstein
authors.affiliation: Department of Dermatology and Allergy, Charité-Universitätsmedizin, Berlin, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Maurer
authors.affiliation: Division of Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center, Baltimore, Md.
authors.forename: Sarbjit S
authors.initials: SS
authors.lastname: Saini
authors.affiliation: Genentech Inc., South San Francisco, Calif.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Trzaskoma
authors.affiliation: Genentech Inc., South San Francisco, Calif.
authors.forename: Hubert
authors.initials: H
authors.lastname: Chen
authors.affiliation: Department of Dermatology, Norfolk and Norwich University Hospital, Norwich, United Kingdom.
authors.forename: Clive E
authors.initials: CE
authors.lastname: Grattan
authors.affiliation: Department of Dermatology, Institut Mar d'Investigacions Mediques, Universitat Autonoma, Barcelona, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Gimenéz-Arnau
authors.affiliation: Department of Medicine, Division of Pulmonary and Critical Care and Allergy and Clinical Immunology, The Medical University of South Carolina, Charleston, SC.
authors.forename: Allen P
authors.initials: AP
authors.lastname: Kaplan
authors.affiliation: Genentech Inc., South San Francisco, Calif. Electronic address: rosen.karin@gene.com.
authors.forename: Karin
authors.initials: K
authors.lastname: Rosén
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D002908:Chronic Disease; D054796:Drug Dosage Calculations; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006634:Histamine H1 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006635:Histamine H2 Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D016896:Treatment Outcome; D014581:Urticaria / Q000276:immunology / Q000628:therapy*
chemical_list: D006634:Histamine H1 Antagonists; D006635:Histamine H2 Antagonists; D000069444:Omalizumab
keywords: Antihistamine; Chronic idiopathic; Chronic spontaneous; Hive; Itch; Omalizumab; Pruritus; Urticaria; Wheal