title: Effect of omalizumab on angioedema in H1 -antihistamine-resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial.
abstract: Chronic spontaneous urticaria (CSU) severely impacts quality of life (QoL), especially in patients with wheals and angioedema. Omalizumab is approved as add-on therapy for CSU patients; however, its effect on patients who are double-positive for wheals and angioedema has not been systematically studied.
  
  
  
  The primary objective was to evaluate the efficacy of omalizumab vs placebo at week 28 using the Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire. Number of angioedema-burdened days, time interval between successive angioedema episodes, disease activity, angioedema-specific and overall QoL impairment were secondary objectives.
  
  
  
  X-ACT was a phase III, randomized, double-blind study conducted in 24 centres (Germany), which selectively included CSU patients with angioedema and wheals. Patients were randomized (1 : 1) to omalizumab 300 mg or placebo (every 4 weeks up to week 24) (ClinicalTrials.gov number: NCT01723072).
  
  
  
  Of the 91 patients randomized to omalizumab (n = 44) or placebo (n = 47) at baseline, 68 completed the 28-week treatment phase (omalizumab, 35; placebo, 33). Omalizumab was superior to placebo in improving CU-Q2oL scores at week 28 (P < 0.001). There was a threefold improvement in angioedema-burdened days/week with omalizumab (0.3) vs placebo (1.1). The median time to first recurrence of angioedema was 57-63 days with omalizumab and <5 days with placebo. Omalizumab significantly improved angioedema-specific QoL (P < 0.001). The adverse events reported are in line with the established safety profile of omalizumab.
  
  
  
  Omalizumab was an effective treatment option for patients with moderate-to-severe CSU symptoms and angioedema unresponsive to high doses of antihistamine treatment.
authors.affiliation: Hautklinik und Poliklinik, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Staubach
authors.affiliation: Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Metz
authors.affiliation: Novartis Pharma GmbH, Nürnberg, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Chapman-Rothe
authors.affiliation: Novartis Pharma GmbH, Nürnberg, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Sieder
authors.affiliation: Novartis Pharma GmbH, Nürnberg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Bräutigam
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Canvin
authors.affiliation: Allergie-Centrum-Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Maurer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000799:Angioedema / Q000175:diagnosis / Q000188:drug therapy*; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004351:Drug Resistance; D005260:Female; D006634:Histamine H1 Antagonists / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D019233:Retreatment; D016896:Treatment Outcome; D014581:Urticaria / Q000175:diagnosis / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D006634:Histamine H1 Antagonists; D000069444:Omalizumab
keywords: angioedema; chronic spontaneous urticaria; chronic urticaria quality of life questionnaire; omalizumab; quality of life