title: Efficacy and safety of omalizumab in patients with chronic urticaria who exhibit IgE against thyroperoxidase.
abstract: BACKGROUND
  A subgroup of patients with chronic spontaneous urticaria (CU) exhibits IgE antibodies directed against autoantigens, such as thyroperoxidase (TPO). We conducted this study to investigate whether such patients with CU with IgE against TPO benefit from treatment with omalizumab, a humanized anti-IgE mAb licensed for the treatment of severe persistent allergic (IgE-mediated) asthma.
  
  
  OBJECTIVE
  We sought to assess the efficacy of omalizumab treatment in patients with CU with IgE autoantibodies against TPO.
  
  
  METHODS
  In this multicenter, randomized, double-blind, placebo-controlled study patients with CU (male/female, 18-70 years of age) with IgE autoantibodies against TPO who had persistent symptoms (wheals and pruritus) despite standard antihistamine therapy were randomized to receive either omalizumab (75-375 mg, dose determined by using the approved asthma dosing table) or placebo subcutaneously once every 2 or 4 weeks for 24 weeks. The primary end point was the change from baseline in mean weekly urticaria activity score after 24 weeks of treatment, as calculated from patients' diaries. The safety and tolerability of omalizumab were also assessed.
  
  
  RESULTS
  Of the 49 randomized patients (omalizumab, n = 27; placebo, n = 22), 42 completed the study. At week 24, patients demonstrated a mean reduction in the weekly urticaria activity score from baseline of 17.8 with omalizumab and 7.9 with placebo (P = .0089). Complete protection from wheal development was observed in 19 (70.4%) patients in the omalizumab group compared with only 1 (4.5%) patient in the placebo group. The rate of adverse events was similar in both groups.
  
  
  CONCLUSIONS
  The results of this study indicate that omalizumab is an effective treatment option for patients with CU with IgE autoantibodies against TPO who are refractory to conventional treatment.
authors.affiliation: Charité-Universitätsmedizin Berlin, Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Berlin, Germany. marcus.maurer@charite.de
authors.forename: Marcus
authors.initials: M
authors.lastname: Maurer
authors.forename: Sabine
authors.initials: S
authors.lastname: Altrichter
authors.forename: Thomas
authors.initials: T
authors.lastname: Bieber
authors.forename: Tilo
authors.initials: T
authors.lastname: Biedermann
authors.forename: Matthias
authors.initials: M
authors.lastname: Bräutigam
authors.forename: Stefan
authors.initials: S
authors.lastname: Seyfried
authors.forename: Randolf
authors.initials: R
authors.lastname: Brehler
authors.forename: Jürgen
authors.initials: J
authors.lastname: Grabbe
authors.forename: Nicolas
authors.initials: N
authors.lastname: Hunzelmann
authors.forename: Thilo
authors.initials: T
authors.lastname: Jakob
authors.forename: Andreas
authors.initials: A
authors.lastname: Jung
authors.forename: Jörg
authors.initials: J
authors.lastname: Kleine-Tebbe
authors.forename: Martin
authors.initials: M
authors.lastname: Mempel
authors.forename: Michael
authors.initials: M
authors.lastname: Meurer
authors.forename: Kristian
authors.initials: K
authors.lastname: Reich
authors.forename: Franziska
authors.initials: F
authors.lastname: Ruëff
authors.forename: Knut
authors.initials: K
authors.lastname: Schäkel
authors.forename: Kaushik
authors.initials: K
authors.lastname: Sengupta
authors.forename: Christian
authors.initials: C
authors.lastname: Sieder
authors.forename: Jan C
authors.initials: JC
authors.lastname: Simon
authors.forename: Bettina
authors.initials: B
authors.lastname: Wedi
authors.forename: Torsten
authors.initials: T
authors.lastname: Zuberbier
authors.forename: Vera
authors.initials: V
authors.lastname: Mahler
authors.forename: Petra
authors.initials: P
authors.lastname: Staubach
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001323:Autoantibodies / Q000097:blood* / Q000276:immunology; D001324:Autoantigens / Q000276:immunology*; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D014581:Urticaria / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D001323:Autoantibodies; D001324:Autoantigens; D000069444:Omalizumab; D007073:Immunoglobulin E