BACKGROUND: Axial spondyloarthropathy typically has its onset in early adulthood and can impact significantly on quality of life. In the UK, biologic anti- @entity5 @entity39 factor therapy is recommended for @entity1 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 @entity5145 . Long-term "real-world" surveillance data are required to complement data from randomised controlled trials. METHODS/DESIGN: We are conducting a UK-wide prospective cohort study of @entity1 with @entity5145 who are na  ve to biologic therapy at the time of recruitment. Those about to commence anti- @entity5 @entity39 factor biologic therapy will enter a "biologic" sub-cohort with other @entity1 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 @entity281 , 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 @entity1 cohorts. @entity1 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. DISCUSSION: Although biologic therapy is widely used for @entity1691 @entity1 who are unresponsive to non-steroidal anti-inflammatory drugs, the majority of the available safety information comes from @entity309 , where @entity281 risk has consistently been shown. However, given the typical demographic differences between @entity309 and @entity5145 @entity1 , it is important to develop an epidemiologically rigorous cohort of @entity1 receiving biologic therapy to effectively evaluate outcomes with regard not only to safety but also to quantify benefits across clinical, psychosocial and work outcomes. CLINICAL TRIAL REGISTRATION: This is an observational cohort study and clinical trial registration was not required or obtained.

The British Society for Rheumatology Biologics Registers in XXXX (BSRBR-AS) study: Protocol for a prospective cohort study of the long-term safety and quality of life outcomes of biologic treatment.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity39 :: ('MESH:D009336', 'Disease') :: ['necrosis'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumour'] @entity281 :: ('MESH:D007239', 'Disease') :: ['increased infection', 'infection'] @entity1691 :: ('MESH:D013167', 'Disease') :: ['ankylosing spondylitis'] @entity5145 :: ('MESH:D025242', 'Disease') :: ['axial spondyloarthropathy'] @entity309 :: ('MESH:D001172', 'Disease') :: ['rheumatoid arthritis']
@entity1691 :: (MESH:D013167,Disease) :: ['Ankylosing Spondylitis']
