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Risk of major adverse cardiovascular and venous thromboembolism events in patients with rheumatoid arthritis exposed to JAK inhibitors versus adalimumab: a nationwide cohort study
  1. Lea Hoisnard1,2,3,
  2. Laura Pina Vegas1,3,4,
  3. Rosemay Dray-Spira5,
  4. Alain Weill5,
  5. Mahmoud Zureik5,
  6. Emilie Sbidian1,2,3,5,6
  1. 1Fédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique - Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, Créteil, Île-de-France, France
  2. 2Centre d’Investigation Clinique 1430, INSERM, Créteil, Ile-de-France, France
  3. 3EpiDermE Epidemiology in Dermatology and Evaluation of Therapeutics, EA7379, Paris ESt Créteil University UPEC, Créteil, France
  4. 4Department of Rheumatology, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, Créteil, France
  5. 5EPI-PHARE Scientific Interest Group in Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety, French National Health Insurance, Saint-Denis, France
  6. 6Department of Dermatology, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, Créteil, France
  1. Correspondence to Dr Lea Hoisnard, Fédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique - Hôpitaux de Paris, Paris, Île-de-France, France; lea.hoisnard{at}aphp.fr

Abstract

Objectives To assess the risk of major adverse cardiovascular events (MACEs) and venous thromboembolism events (VTEs) among patients initiating a Janus kinase inhibitor (JAKi) (tofacitinib and baricitinib) versus adalimumab in a large real-world population of patients with rheumatoid arthritis.

Methods We conducted a nationwide population-based cohort study of the French national health data system, the exposed group initiating a JAKi and non-exposed group initiating adalimumab. We included all individuals who had their first dispensation of a JAKi or adalimumab between 1 July 2017 and 31 May 2021 and had rheumatoid arthritis. The primary endpoints were the occurrence of a MACE or VTE. Weighted hazard ratio (HRw) values were estimated with the inverse probability of treatment weighting method to account for confounding factors with concomitant administration of methotrexate as a time-varying variable.

Results The cohort included 15 835 patients: 8481 and 7354 in the exposed and non-exposed groups (mean age 59.3 and 55.3 years, female 78.3% and 71.2%, respectively). During follow-up, 54 and 35 MACEs and 75 and 32 VTEs occurred in the exposed and non-exposed groups, respectively. Risk of MACEs for the exposed versus non-exposed group was not significant: HRw 1.0 (95% CI 0.7 to 1.5) (p=0.99), nor was risk of VTEs significant: HRw 1.1 (0.7 to 1.6) (p=0.63). Despite a lack of power, results were consistent among patients aged 65 years or older with at least one cardiovascular risk factor.

Conclusions This study provides reassuring data regarding the risks of MACEs and VTEs in patients initiating a JAKi versus adalimumab, including patients at high risk of cardiovascular diseases.

  • antirheumatic agents
  • adalimumab
  • arthritis, rheumatoid
  • epidemiology

Data availability statement

No data are available. Data sharing is not applicable. According to data protection and the French regulation, the authors cannot publicly release the data from the French national health data system (SNDS). However, any person or structure, public or private, for-profit or nonprofit, is able to access SNDS data upon authorization from the French Data Protection Office (CNIL Commission Nationale de l’Informatique et des Libertés) to carry out a study, research, or an evaluation of public interest (https://www.snds.gouv.fr/SNDS/Processus-d-acces-aux-donnees and https://www.indsante.fr/).

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Data availability statement

No data are available. Data sharing is not applicable. According to data protection and the French regulation, the authors cannot publicly release the data from the French national health data system (SNDS). However, any person or structure, public or private, for-profit or nonprofit, is able to access SNDS data upon authorization from the French Data Protection Office (CNIL Commission Nationale de l’Informatique et des Libertés) to carry out a study, research, or an evaluation of public interest (https://www.snds.gouv.fr/SNDS/Processus-d-acces-aux-donnees and https://www.indsante.fr/).

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Footnotes

  • Handling editor Josef S Smolen

  • Twitter @epi_derm

  • Contributors Conceptualisation: LH, RD-S, AW, MZ and ES; methodology: LH and ES; formal analysis: LH; investigation: LH; resources: MZ, AW and RD-S; data curation: LH; writing—original draft preparation: LH; writing—review and editing: LH, LPV, RD-S, AW, MZ and ES; visualisation: LH; supervision: MZ and ES. Guarantor: ES. All authors have read and agreed to the published version of the manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

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

  • 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.