title: The British Society for Rheumatology Biologics Registers in Ankylosing Spondylitis (BSRBR-AS) study: Protocol for a prospective cohort study of the long-term safety and quality of life outcomes of biologic treatment.
abstract: BACKGROUND
  Axial spondyloarthropathy typically has its onset in early adulthood and can impact significantly on quality of life. In the UK, biologic anti-tumour necrosis factor therapy is recommended for patients who are unresponsive to non-steroidal anti-inflammatory drugs. There remain several unresolved issues about the long-term safety and quality of life outcomes of biologic treatment in axial spondyloarthropathy. Long-term "real-world" surveillance data are required to complement data from randomised controlled trials.
  
  
  METHODS
  We are conducting a UK-wide prospective cohort study of patients with axial spondyloarthropathy who are naïve to biologic therapy at the time of recruitment. Those about to commence anti-tumour necrosis factor biologic therapy will enter a "biologic" sub-cohort with other patients assigned to a "non-biologic" sub-cohort. The primary objective is to determine whether the use of biologic therapy is associated with an increased risk of serious infection, while secondary objectives are to assess differences in malignancy, serious comorbidity, all-cause mortality but also assess impact on specific clinical domains (physical health, mental health and quality of life) including work outcomes between biologic and non-biologic patient cohorts. Patients will be followed-up for up to 5 years. Data are obtained at baseline and at standard clinical follow-up visits - at 3, 6 and 12 months and then annually for the biologic cohort and annually for the non-biologic cohort. This study will also collect biological samples for genetic analysis.
  
  
  CONCLUSIONS
  Although biologic therapy is widely used for ankylosing spondylitis patients who are unresponsive to non-steroidal anti-inflammatory drugs, the majority of the available safety information comes from rheumatoid arthritis, where increased infection risk has consistently been shown. However, given the typical demographic differences between rheumatoid arthritis and axial spondyloarthropathy patients, it is important to develop an epidemiologically rigorous cohort of patients receiving biologic therapy to effectively evaluate outcomes with regard not only to safety but also to quantify benefits across clinical, psychosocial and work outcomes.
  
  
  BACKGROUND
  This is an observational cohort study and clinical trial registration was not required or obtained.
authors.affiliation: Musculoskeletal Research Collaboration (Epidemiology Group), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. g.j.macfarlane@abdn.ac.uk.
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Macfarlane
authors.affiliation: Musculoskeletal Research Collaboration (Epidemiology Group), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. maxwell.barnish@abdn.ac.uk.
authors.forename: Maxwell S
authors.initials: MS
authors.lastname: Barnish
authors.affiliation: Musculoskeletal Research Collaboration (Epidemiology Group), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. elizabeth.jones@abdn.ac.uk.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Jones
authors.affiliation: Department of Rheumatology, Freeman Hospital, Newcastle upon Tyne, UK. lesley.kay@nuth.nhs.uk.
authors.forename: Lesley
authors.initials: L
authors.lastname: Kay
authors.affiliation: Rheumatology Department, Northwick Park Hospital, London, UK. a.keat@nhs.net.
authors.forename: Andrew
authors.initials: A
authors.lastname: Keat
authors.affiliation: Musculoskeletal Research Collaboration (Epidemiology Group), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. k.t.meldrum@dundee.ac.uk.
authors.forename: Karen T
authors.initials: KT
authors.lastname: Meldrum
authors.affiliation: Department of Rheumatology, Aberdeen Royal Infirmary, Aberdeen, UK. ejaz.pathan@nhs.net.
authors.forename: Ejaz
authors.initials: E
authors.lastname: Pathan
authors.affiliation: Division of Immunology, Infection and Inflammation, University of Glasgow, Glasgow, UK. roger.sturrock@glasgow.ac.uk.|Centre for Rheumatic Diseases, Glasgow Royal Infirmary, Glasgow, UK. roger.sturrock@glasgow.ac.uk.
authors.forename: Roger D
authors.initials: RD
authors.lastname: Sturrock
authors.affiliation: Musculoskeletal Research Collaboration (Epidemiology Group), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. c.zabke@abdn.ac.uk.
authors.forename: Claudia
authors.initials: C
authors.lastname: Zabke
authors.affiliation: Health Economics Research Unit, Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. p.mcnamee@abdn.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: McNamee
authors.affiliation: Musculoskeletal Research Collaboration (Epidemiology Group), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. gareth.jones@abdn.ac.uk.
authors.forename: Gareth T
authors.initials: GT
authors.lastname: Jones
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001688:Biological Products / Q000627:therapeutic use*; D006801:Humans; D011446:Prospective Studies; D012107:Research Design; D012219:Rheumatology; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D006113:United Kingdom
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products