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

Gary J Macfarlane, Maxwell S Barnish, Elizabeth A Jones, Lesley Kay, Andrew Keat, Karen T Meldrum, Ejaz Pathan, Roger D Sturrock, Claudia Zabke, Paul McNamee, Gareth T Jones

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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/DESIGN: 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.

DISCUSSION: 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.

CLINICAL TRIAL REGISTRATION: This is an observational cohort study and clinical trial registration was not required or obtained.

Original languageEnglish
Article number347
JournalBMC Musculoskeletal Disorders
Volume16
DOIs
Publication statusPublished - 11 Nov 2015

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Ankylosing Spondylitis
Biological Products
Cohort Studies
Biological Therapy
Quality of Life
Prospective Studies
Safety
Spondylarthropathies
Rheumatoid Arthritis
Anti-Inflammatory Agents
Tumor Necrosis Factor-alpha
Coinfection
Pharmaceutical Preparations
Observational Studies
Comorbidity
Mental Health
Randomized Controlled Trials
Demography
Clinical Trials
Mortality

Keywords

  • axial spondyloarthropathy
  • ankylosing spondylitis
  • biologic therapy
  • safety
  • infection
  • cohort

Cite this

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. / Macfarlane, Gary J; Barnish, Maxwell S; Jones, Elizabeth A; Kay, Lesley; Keat, Andrew; Meldrum, Karen T; Pathan, Ejaz; Sturrock, Roger D; Zabke, Claudia; McNamee, Paul; Jones, Gareth T.

In: BMC Musculoskeletal Disorders, Vol. 16, 347, 11.11.2015.

Research output: Contribution to journalArticle

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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/DESIGN: We are conducting a UK-wide prospective cohort study of patients with axial spondyloarthropathy who are na{\"i}ve 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.DISCUSSION: 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.CLINICAL TRIAL REGISTRATION: This is an observational cohort study and clinical trial registration was not required or obtained.",
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note = "Acknowledgements Oversight of the study is provided by the BSR Registers Committee of which GJM and GTJ are members, together with investigators from BSRBR-RA, representatives from the BSR clinical affairs section and BSR independent members, currently, Alex MacGregor (University of East Anglia), Elaine Dennison (University of Southampton), Jon Packham (Keele University) and patient representatives Ailsa Bosworth and Debbie Cook. We acknowledge the contribution of the International Advisory Group members Desire{\'e} van der Heijde (Netherlands), Matthew Brown (Australia) and Walter Maksymowych (Canada). We thank Neil Basu (University of Aberdeen) for his role with regards to pharmacovigilance and the Robertson Centre for Biostatistics (University of Glasgow) for data management services. Author KTM is currently at the Tayside Clinical Trials Unit, University of Dundee. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.",
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T1 - The British Society for Rheumatology Biologics Registers in Ankylosing Spondylitis (BSRBR-AS) study

T2 - Protocol for a prospective cohort study of the long-term safety and quality of life outcomes of biologic treatment

AU - Macfarlane, Gary J

AU - Barnish, Maxwell S

AU - Jones, Elizabeth A

AU - Kay, Lesley

AU - Keat, Andrew

AU - Meldrum, Karen T

AU - Pathan, Ejaz

AU - Sturrock, Roger D

AU - Zabke, Claudia

AU - McNamee, Paul

AU - Jones, Gareth T

N1 - Acknowledgements Oversight of the study is provided by the BSR Registers Committee of which GJM and GTJ are members, together with investigators from BSRBR-RA, representatives from the BSR clinical affairs section and BSR independent members, currently, Alex MacGregor (University of East Anglia), Elaine Dennison (University of Southampton), Jon Packham (Keele University) and patient representatives Ailsa Bosworth and Debbie Cook. We acknowledge the contribution of the International Advisory Group members Desireé van der Heijde (Netherlands), Matthew Brown (Australia) and Walter Maksymowych (Canada). We thank Neil Basu (University of Aberdeen) for his role with regards to pharmacovigilance and the Robertson Centre for Biostatistics (University of Glasgow) for data management services. Author KTM is currently at the Tayside Clinical Trials Unit, University of Dundee. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

PY - 2015/11/11

Y1 - 2015/11/11

N2 - 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/DESIGN: 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.DISCUSSION: 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.CLINICAL TRIAL REGISTRATION: This is an observational cohort study and clinical trial registration was not required or obtained.

AB - 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/DESIGN: 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.DISCUSSION: 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.CLINICAL TRIAL REGISTRATION: This is an observational cohort study and clinical trial registration was not required or obtained.

KW - axial spondyloarthropathy

KW - ankylosing spondylitis

KW - biologic therapy

KW - safety

KW - infection

KW - cohort

U2 - 10.1186/s12891-015-0805-x

DO - 10.1186/s12891-015-0805-x

M3 - Article

VL - 16

JO - BMC Musculoskeletal Disorders

JF - BMC Musculoskeletal Disorders

SN - 1471-2474

M1 - 347

ER -