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Epidemiology
Original research
Risk of venous thromboembolism in immune-mediated inflammatory diseases: a UK matched cohort study
  1. James Galloway1,
  2. Kevin Barrett2,
  3. Peter Irving3,4,
  4. Kaivan Khavandi5,
  5. Monica Nijher5,
  6. Ruth Nicholson5,
  7. Simon de Lusignan6,7 and
  8. Maya H Buch8,9
  1. 1 Centre for Rheumatic Diseases, King’s College London, London, UK
  2. 2 New Road Surgery, Croxley Green, Hertfordshire, UK
  3. 3 Department of Gastroenterology, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
  4. 4 School of Immunology and Microbial Sciences, King’s College London, London, UK
  5. 5 Pfizer Innovative Health, Tadworth, UK
  6. 6 Royal College of General Practitioners Research and Surveillance Centre (RSC), London, UK
  7. 7 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  8. 8 Centre for Musculoskeletal Research, School of Biological Sciences, The University of Manchester, Manchester, UK
  9. 9 NIHR Manchester Biomedical Research Centre, Manchester, UK
  1. Correspondence to Maya H Buch; maya.buch{at}manchester.ac.uk

Abstract

Objectives To describe the risk of venous thromboembolism (VTE), and risk factors for VTE, in people with immune-mediated inflammatory diseases (IMID) (ulcerative colitis, Crohn’s disease (CD), rheumatoid arthritis (RA) and psoriatic arthritis (PsA)), compared with a matched control population.

Methods A total of 53 378 people with an IMID were identified over 1999–2019 in the UK Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) primary care database and were matched to 213 512 people without an IMID. The association between the presence of any IMID, and each IMID separately, and risk of VTE was estimated using unadjusted and multivariable-adjusted Cox proportional hazards models. The prevalence of VTE risk factors, and associations between VTE risk factors and risk of VTE, were estimated in people with and without an IMID.

Results People with an IMID were at increased risk of VTE (adjusted HR [aHR] 1.46, 95% CI 1.36,1.56), compared with matched controls. When assessing individual diseases, risk was increased for CD (aHR 1.74, 95% CI 1.45 to 2.08), ulcerative colitis (aHR 1.27, 95% CI 1.10 to 1.45) and RA (aHR 1.54, 95% CI 1.40 to 1.70) but there was no evidence of an association for PsA (aHR 1.21, 95% CI 0.96 to 1.52). In people with an IMID, independent risk factors for VTE included male sex, overweight/obese body mass index, current smoking, history of fracture, and, across study follow-up, abnormal platelet count.

Conclusions VTE risk is increased in people with IMIDs. Routinely available clinical information may be helpful to identify individuals with an IMID at increased future risk of VTE.

Observational study registration number Clinicaltrials.gov (NCT03835780).

  • Inflammation
  • Rheumatoid
  • Epidemiology
  • Arthritis
  • Psoriatic
  • Autoimmune Diseases
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/rmdopen-2020-001392

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    Footnotes

    • Contributors JG, KB, PI, KK, MN, RN, SdeL and MHB designed the study, supervised the data analysis, provided the interpretation of results, and contributed to the drafting and critical review of the manuscript. All authors approved the final draft. Medical writing and statistical support, funded by Pfizer, was provided by John Dennis (PhD), Andrew McGovern (MD) and Anita Lynam (PhD) [Momentum Data], with project management support from Filipa Ferreira (PhD) [University of Surrey]. As corresponding author, MHB attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. MHB is the guarantor and accepts full responsibility for the conduct of the study, had access to the data, and controlled the decision to publish.

    • Funding This study, and medical writing support, was funded by Pfizer. As study authors, representatives of Pfizer contributed to the design and conduct of the study, interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    • Competing interests All authors have completed the ICMJE uniform disclosure form at URL: www.icmje.org/coi_disclosure.pdf and declare: JG has received honoraria and/or sponsorships for conferences from AbbVie, Celgene, Janssen, Pfizer and UCB. KB has received honoraria from Tillots, Thermo Fisher Scientific, Boehringer Ingelheim, Pfizer, and Yakult. PI has received lecture fees from AbbVie, Celgene, Falk Pharma, Ferring, MSD, Janssen, Pfizer, Takeda, Tillotts, Sapphire Medical, Sandoz, Shire, and Warner Chilcott; financial support for research from MSD, Pfizer, and Takeda; advisory fees from AbbVie, Arena, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Prometheus, Roche, Sandoz, Samsung Bioepis, Takeda, Topivert, VH2, Vifor Pharma, and Warner Chilcott. KK, MN and RN are employees of Pfizer. SdeL is Director of the RCGP RSC, he has received funding through his universities from Eli Lilly, GSK, Astra Zeneca, MSD, Sanofi, Seqirus, and Takeda. MHB has provided expert advice and received consultant fees and/or sponsorship for conference from AbbVie, Boehringer ingelheim, Eli Lilly, EMD Serono, Gilead, Pfizer, Roche, and Sanofi and has received research grants paid to her employer from Pfizer, Roche and UCB.

    • Patient consent for publication This research was done without patient involvement. Patients were not invited to comment on the study design and were not consulted to develop patient relevant outcomes or interpret the results. Patients were not invited to contribute to the writing or editing of this document for readability or accuracy.

    • Ethics approval Study approval was granted by the Research Committee of the RCGP RSC. The study did not meet the requirements for formal ethics board review as defined using the NHS Health Research Authority research decision tool (URL: http://www.hra-decisiontools.org.uk/research/).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement No additional data are available from the authors although Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) United Kingdom primary care data are available by application to the Research Committee of the RCGP RS.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.