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Research ArticleArticle

Inflammatory Bowel Disease Risk in Patients With Axial Spondyloarthritis Treated With Biologic Agents Determined Using the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis: A MetaAnalysis

Gary J. Macfarlane, Renke Biallas, Linda E. Dean, Gareth T. Jones, Nicola J. Goodson and Ovidiu Rotariu
The Journal of Rheumatology July 2022, jrheum.211034; DOI: https://doi.org/10.3899/jrheum.211034
Gary J. Macfarlane
The BSRBR-AS is supported by the British Society for Rheumatology and they have received funds for the registry from Pfizer, AbbVie, and UCB. These companies have no input in determining the topics for analysis or the work involved in undertaking it, but they do receive an advance copy of the manuscript on which they may make comments. G.J. Macfarlane, MD (Hons), R. Biallas, MPH, L.E. Dean, PhD, G.T. Jones, PhD, O. Rotariu, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen; N.J. Goodson, PhD, Rheumatology Department, Liverpool University Foundation Trust, Liverpool, UK. The authors declare no conflicts of interest relevant to this article. Address correspondence to Prof. G.J. Macfarlane, University of Aberdeen, King's College, Aberdeen AB24 3FX, UK. Email: g.j.macfarlane@abdn.ac.uk. Accepted for publication June 20, 2022.
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Renke Biallas
The BSRBR-AS is supported by the British Society for Rheumatology and they have received funds for the registry from Pfizer, AbbVie, and UCB. These companies have no input in determining the topics for analysis or the work involved in undertaking it, but they do receive an advance copy of the manuscript on which they may make comments. G.J. Macfarlane, MD (Hons), R. Biallas, MPH, L.E. Dean, PhD, G.T. Jones, PhD, O. Rotariu, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen; N.J. Goodson, PhD, Rheumatology Department, Liverpool University Foundation Trust, Liverpool, UK. The authors declare no conflicts of interest relevant to this article. Address correspondence to Prof. G.J. Macfarlane, University of Aberdeen, King's College, Aberdeen AB24 3FX, UK. Email: g.j.macfarlane@abdn.ac.uk. Accepted for publication June 20, 2022.
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Linda E. Dean
The BSRBR-AS is supported by the British Society for Rheumatology and they have received funds for the registry from Pfizer, AbbVie, and UCB. These companies have no input in determining the topics for analysis or the work involved in undertaking it, but they do receive an advance copy of the manuscript on which they may make comments. G.J. Macfarlane, MD (Hons), R. Biallas, MPH, L.E. Dean, PhD, G.T. Jones, PhD, O. Rotariu, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen; N.J. Goodson, PhD, Rheumatology Department, Liverpool University Foundation Trust, Liverpool, UK. The authors declare no conflicts of interest relevant to this article. Address correspondence to Prof. G.J. Macfarlane, University of Aberdeen, King's College, Aberdeen AB24 3FX, UK. Email: g.j.macfarlane@abdn.ac.uk. Accepted for publication June 20, 2022.
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Gareth T. Jones
The BSRBR-AS is supported by the British Society for Rheumatology and they have received funds for the registry from Pfizer, AbbVie, and UCB. These companies have no input in determining the topics for analysis or the work involved in undertaking it, but they do receive an advance copy of the manuscript on which they may make comments. G.J. Macfarlane, MD (Hons), R. Biallas, MPH, L.E. Dean, PhD, G.T. Jones, PhD, O. Rotariu, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen; N.J. Goodson, PhD, Rheumatology Department, Liverpool University Foundation Trust, Liverpool, UK. The authors declare no conflicts of interest relevant to this article. Address correspondence to Prof. G.J. Macfarlane, University of Aberdeen, King's College, Aberdeen AB24 3FX, UK. Email: g.j.macfarlane@abdn.ac.uk. Accepted for publication June 20, 2022.
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Nicola J. Goodson
The BSRBR-AS is supported by the British Society for Rheumatology and they have received funds for the registry from Pfizer, AbbVie, and UCB. These companies have no input in determining the topics for analysis or the work involved in undertaking it, but they do receive an advance copy of the manuscript on which they may make comments. G.J. Macfarlane, MD (Hons), R. Biallas, MPH, L.E. Dean, PhD, G.T. Jones, PhD, O. Rotariu, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen; N.J. Goodson, PhD, Rheumatology Department, Liverpool University Foundation Trust, Liverpool, UK. The authors declare no conflicts of interest relevant to this article. Address correspondence to Prof. G.J. Macfarlane, University of Aberdeen, King's College, Aberdeen AB24 3FX, UK. Email: g.j.macfarlane@abdn.ac.uk. Accepted for publication June 20, 2022.
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Ovidiu Rotariu
The BSRBR-AS is supported by the British Society for Rheumatology and they have received funds for the registry from Pfizer, AbbVie, and UCB. These companies have no input in determining the topics for analysis or the work involved in undertaking it, but they do receive an advance copy of the manuscript on which they may make comments. G.J. Macfarlane, MD (Hons), R. Biallas, MPH, L.E. Dean, PhD, G.T. Jones, PhD, O. Rotariu, PhD, Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen; N.J. Goodson, PhD, Rheumatology Department, Liverpool University Foundation Trust, Liverpool, UK. The authors declare no conflicts of interest relevant to this article. Address correspondence to Prof. G.J. Macfarlane, University of Aberdeen, King's College, Aberdeen AB24 3FX, UK. Email: g.j.macfarlane@abdn.ac.uk. Accepted for publication June 20, 2022.
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Abstract

Objective To determine, among patients with axial spondyloarthritis (axSpA), whether the risk of inflammatory bowel disease (IBD) varies between patients treated with biologic therapies and those treated with other therapies and, specifically, whether the risk is higher in patients treated with etanercept (ETN).

Methods The British Society for Rheumatology Biologics Register in Ankylosing Spondylitis (BSRBR-AS) was used to determine the incidence of IBD during follow-up and to calculate the incidence rate difference (IRD) per 1000 person-years (PY), between biologic treatment and other treatment groups. We then conducted a systematic review, involving observational studies and randomized controlled trials (RCTs), to perform a metaanalysis to quantify the difference in incidence of IBD between treatment groups.

Results According to the BSRBR-AS, among people with axSpA, exposure to biologic therapy was associated with an increased incidence of IBD compared to those who were not exposed to biologic therapy (IRD 11.9, 95% CI 4.3-19.6). This finding was replicated across observational studies but was not seen in placebo-controlled RCTs (IRD 2.2, 95% CI –4.1 to 8.5). Data from the BSRBR-AS do not suggest that excess incidence of IBD is associated with exposure to ETN compared to other anti–tumor necrosis factor (TNF) therapies (IRD –6.5, 95% CI –21.3 to 8.5). RCTs and their extensions suggest a small—yet not statistically significant—absolute increased incidence associated with ETN of between 2.1 and 5.8 per 1000 PY compared to other anti-TNF therapies.

Conclusion There was an excess risk of IBD among persons treated with biologics in observational studies. Only evidence from RCTs suggested that ETN was associated with an increased risk compared to other anti-TNF therapies, albeit with considerable uncertainty.

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The Journal of Rheumatology
Vol. 50, Issue 1
1 Jan 2023
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Inflammatory Bowel Disease Risk in Patients With Axial Spondyloarthritis Treated With Biologic Agents Determined Using the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis: A MetaAnalysis
Gary J. Macfarlane, Renke Biallas, Linda E. Dean, Gareth T. Jones, Nicola J. Goodson, Ovidiu Rotariu
The Journal of Rheumatology Jul 2022, jrheum.211034; DOI: 10.3899/jrheum.211034

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Inflammatory Bowel Disease Risk in Patients With Axial Spondyloarthritis Treated With Biologic Agents Determined Using the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis: A MetaAnalysis
Gary J. Macfarlane, Renke Biallas, Linda E. Dean, Gareth T. Jones, Nicola J. Goodson, Ovidiu Rotariu
The Journal of Rheumatology Jul 2022, jrheum.211034; DOI: 10.3899/jrheum.211034
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