title: Analysis of disease activity categories in chronic spontaneous/idiopathic urticaria.
abstract: BACKGROUND
  Measurement of disease activity guides treatment of chronic spontaneous urticaria (CSU). A weekly Urticaria Activity Score - here, the average of twice-daily patient assessment of itch and hives scores summed over 1 week (UAS7TD) - measures severity from 0 to 42. Insufficient evidence exists on whether disease activity states, defined by categorical UAS7TDscores, correlate with other patient-reported outcomes and treatment response.
  
  
  OBJECTIVE
  To evaluate and compare categorical UAS7TDscores with selected measures of disease-related quality of life and impact.
  
  
  METHODS
  Data from three randomized clinical trials of omalizumab in CSU were pooled. Continuous UAS7TDscores were categorized into five disease activity states: urticaria-free, well-controlled, mild, moderate and severe urticaria. Total scores from the Dermatology Life Quality Index; the Chronic Urticaria Quality of Life questionnaire; and questions on sleep and daily activity interference, presence of angioedema and diphenhydramine use were compared within categorized UAS7TDdisease-state scores, using anova for analysis at different time points and mixed-effects regressions for analysis of all data pooled.
  
  
  RESULTS
  Pooled analyses showed that categorical UAS7TDdisease states accurately predicted differences among treated patients with CSU with different levels of disease activity. A consistent pattern existed between categories, with higher-activity disease states associated with significantly higher impact and an increase in angioedema frequency. Results at different treatment time points were consistent.
  
  
  CONCLUSIONS
  Categorical UAS7TDdisease states can discriminate between measures when considering the impact of urticaria activity. Using five categorical disease states could simplify clinical assessment and monitoring of treatment efficacy.
authors.affiliation: RTI Health Solutions, 200 Park Offices Drive, PO Box 12194, Research Triangle Park, NC, 27709-2194, U.S.A.
authors.forename: D
authors.initials: D
authors.lastname: Stull
authors.affiliation: RTI Health Solutions, The Pavilion, Towers Business Park, Wilmslow Road, Didsbury, Manchester, M20 2LS, U.K.
authors.forename: D
authors.identifier: http://orcid.org/0000-0002-2545-651X
authors.initials: D
authors.lastname: McBride
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, U.S.A.
authors.forename: H
authors.initials: H
authors.lastname: Tian
authors.affiliation: Department of Dermatology, Hospital del Mar and Universitat Autònoma, Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Gimenez Arnau
authors.affiliation: Department of Dermatology and Allergy, Allergie-Centrum-Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Maurer
authors.affiliation: Dermatology Department, Salford Royal Hospital and University of Manchester, Manchester, U.K.
authors.forename: A
authors.initials: A
authors.lastname: Marsland
authors.affiliation: Novartis Pharma AG, GMA & HEOR, Novartis Campus, Basel, 4056, Switzerland.
authors.forename: M-M
authors.initials: MM
authors.lastname: Balp
authors.affiliation: Novartis Pharma AG, GMA & HEOR, Novartis Campus, Basel, 4056, Switzerland.
authors.forename: S
authors.initials: S
authors.lastname: Khalil
authors.affiliation: Cutaneous Allergy, Guy's Hospital, London, U.K.
authors.forename: C
authors.initials: C
authors.lastname: Grattan
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000799:Angioedema / Q000209:etiology; D018926:Anti-Allergic Agents / Q000627:therapeutic use; D002908:Chronic Disease; D003879:Dermatologic Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000069444:Omalizumab / Q000627:therapeutic use; D011537:Pruritus / Q000209:etiology; D011788:Quality of Life; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000209:etiology; D016896:Treatment Outcome; D014581:Urticaria / Q000150:complications* / Q000188:drug therapy
chemical_list: D018926:Anti-Allergic Agents; D003879:Dermatologic Agents; D000069444:Omalizumab