title: Retrospective case note review of chronic spontaneous urticaria outcomes and adverse effects in patients treated with omalizumab or ciclosporin in UK secondary care.
abstract: BACKGROUND
  Omalizumab is approved in the UK as add-on treatment for chronic spontaneous urticaria (CSU) in patients with inadequate response to H1-antihistamines. Ciclosporin is an established but unlicensed 3rd line option for CSU. Two parallel retrospective observational studies were conducted to describe outcomes of treatment and adverse events with omalizumab or ciclosporin for CSU treatment.
  
  
  METHODS
  Data from UK specialist centres prescribing omalizumab (five centres) or ciclosporin (three centres) in CSU patients were collected from hospital records by clinical staff and pooled for analysis.
  
  
  RESULTS
  Forty-six patients prescribed omalizumab and 72 patients prescribed ciclosporin were included. Twenty-two (48%) omalizumab-treated patients had paired Urticaria Activity Scores (UAS7), showing a 25.4 point improvement during treatment (P < 0.0001). Paired Dermatology Life Quality Index (DLQI) was available in 28 (61%) omalizumab-treated and 17 (24%) ciclosporin-treated patients. At least a 75% improvement in DLQI score was observed in 79% of omalizumab-treated and 41% of ciclosporin-treated patients, and 65% of omalizumab-treated patients had complete resolution of their quality-of-life impairment (DLQI 0-1) versus 21% of ciclosporin-treated patients. Clinician comments reported symptom clearance in 15/36 (42%) omalizumab-treated and 10/60 (17%) ciclosporin-treated patients. Proportions of patients with adverse events were similar but those for omalizumab resembled CSU symptoms, making causality assignment difficult, whereas those for ciclosporin were consistent with its known adverse effect profile.
  
  
  CONCLUSIONS
  Validated patient-reported measures of disease severity and quality of life should be used routinely in CSU management. Based on clinician comments and DLQI scores, symptoms and quality of life showed a greater improvement in the omalizumab-treated cohort than in the ciclosporin-treated cohort.
authors.affiliation: St James's University Hospital, Leeds, LS9 7TF UK.
authors.forename: Sinisa
authors.initials: S
authors.lastname: Savic
authors.affiliation: Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, University of Manchester, Manchester, M6 8HD UK.
authors.forename: Alexander
authors.initials: A
authors.lastname: Marsland
authors.affiliation: Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA UK.
authors.forename: David
authors.initials: D
authors.lastname: McKay
authors.affiliation: University Hospital Southampton, Southampton, SO16 6YD UK.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Ardern-Jones
authors.affiliation: Royal Free London NHS Foundation Trust, London, NW3 2QG UK ; St John's Institute of Dermatology, London, SE1 7EH UK.
authors.forename: Tabi
authors.initials: T
authors.lastname: Leslie
authors.affiliation: Novartis Pharmaceuticals UK Ltd, Camberley, Surrey, GU16 7SR UK.
authors.forename: Olivier
authors.initials: O
authors.lastname: Somenzi
authors.affiliation: pH Associates Ltd, Marlow, SL7 1PG UK.
authors.forename: Laura
authors.initials: L
authors.lastname: Baldock
authors.affiliation: St John's Institute of Dermatology, London, SE1 7EH UK ; Dermatology Centre, Norfolk and Norwich University Hospital, Norwich, NR4 7UY UK.
authors.forename: Clive
authors.initials: C
authors.lastname: Grattan
keywords: Chronic spontaneous urticaria; Ciclosporin; Observational; Omalizumab; Retrospective