title: The British Association of Dermatologists' Biologic Interventions Register (BADBIR): design, methodology and objectives.
abstract: BACKGROUND
  The British Association of Dermatologists (BAD) established a web-based pharmacovigilance register to assess the long-term safety of biologics prescribed for patients with severe psoriasis in September 2007. The BAD Biologic Interventions Register (BADBIR) also participates in the network of European psoriasis biologics registers (Psonet).
  
  
  OBJECTIVE
  This prospective observational cohort study compares adult patients with psoriasis treated with biologics vs. a comparator group exposed to conventional systemic therapies.
  
  
  METHODS
  Following baseline data acquisition, clinicians record changes in therapy, disease activity and adverse events for 5years (6-monthly for 3years, then annually thereafter). Patient details are flagged lifelong on the National Health Service Information Centre system to capture occurrence of malignancy or death. Primary study endpoints include malignancy, infection, serious adverse events and death. Collection of long-term effectiveness data is a subsidiary aim.
  
  
  RESULTS
  By November 2011, the number of dermatology centres actively recruiting across the U.K. and Republic of Ireland had risen to 108 and a further 37 were actively engaged in the set-up process. Of the 3176 patients enrolled in the study to date, 2193 were registered within the biologic cohort and 983 in the conventional systemic (nonbiologic-exposed) cohort.
  
  
  CONCLUSIONS
  A robust, high-quality, web-based register of biologic and conventional therapy for psoriasis has been established in the U.K. This is the largest project undertaken by the BAD. The data it will provide over the coming years will be invaluable to the safe use of biologics in clinical practice. A U.K.-wide dermatology clinical research network has been established that provides a framework for future studies in other diseases.
authors.affiliation: Department of Dermatology, Western Infirmary, Glasgow G11 6NT, UK. david.burden@glasgow.ac.uk
authors.forename: A D
authors.initials: AD
authors.lastname: Burden
authors.forename: R B
authors.initials: RB
authors.lastname: Warren
authors.forename: C E
authors.initials: CE
authors.lastname: Kleyn
authors.forename: K
authors.initials: K
authors.lastname: McElhone
authors.forename: C H
authors.initials: CH
authors.lastname: Smith
authors.forename: N J
authors.initials: NJ
authors.lastname: Reynolds
authors.forename: A D
authors.initials: AD
authors.lastname: Ormerod
authors.forename: C E M
authors.initials: CE
authors.lastname: Griffiths
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D001688:Biological Products / Q000009:adverse effects*; D003625:Data Collection; D003879:Dermatologic Agents / Q000009:adverse effects*; D003880:Dermatology; D006801:Humans; D007494:Ireland; D009937:Organizational Objectives; D061214:Patient Safety; D018579:Patient Selection; D060735:Pharmacovigilance; D011565:Psoriasis / Q000188:drug therapy*; D012042:Registries; D012307:Risk Factors; D012955:Societies, Medical; D006113:United Kingdom
chemical_list: D001688:Biological Products; D003879:Dermatologic Agents