Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance
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  • Published on:
    Cardiovascular risk with tofacitinib in Rheumatoid Arthritis: the clinical relevance of atherosclerotic cardiovascular disease on treatment decisions.
    • Fabio Cacciapaglia, rheumatologist Rheumatology Unit - University of Bari, Bari - Italy
    • Other Contributors:
      • Fabrizio Conti, full professor of rheumatology
      • Cristina Garufi, rheumatologist
      • Vincenzo Venerito, rheumatologist
      • Florenzo Iannone, full professor of rheumatology
      • Francesca Romana Spinelli, rheumatologist

    On October 28th, the European Medicine Agency extended to the entire class of Janus Kinase inhibitors (JAKi) the recommendation to use a JAKi only if no suitable therapeutic alternatives are available in patients older than 65 years, those at increased risk of MACE, and those who smoke or have smoked extensively in the past [1].
    The ORAL surveillance would have shown that patients with active rheumatoid arthritis (RA) aged ≥50 years and with at least one additional cardiovascular (CV) risk factor (current smoker, hypertension, low high-density lipoprotein cholesterol, diabetes mellitus, family history of premature coronary heart disease, extra-articular rheumatoid arthritis, or history of coronary artery disease) had an increased risk of major adverse cardiovascular events (MACE) with tofacitinib versus tumour necrosis factor inhibitors (TNFi) [2]. In the ORAL Surveillance not all risk factors were well balanced between the tofacitinib and TNFi arms, i.e, unstable angina was more prevalent in patients taking tofacitinib 5 mg than in those on TNFi (17/1438 vs 7/1444, respectively; Chi-square=4.174, p=0.04), as reported in the Table S2 of the main study [2]. This bias presumably influenced the higher rate of MACE observed in the tofacitinib group. Therefore, we were not surprised that the post-hoc analysis published by Charles-Schoemann et al showed that the difference between tofacitinib and TNFi in the risk of MACE was primarily seen in patients with a history of...

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    Conflict of Interest:
    FCa: speaker fees from Abbvie, Eli Lilly, Galapagos, Pfizer
    FCo: speaker fees from Abbvie, Eli Lilly, Galapagos, Pfizer
    CG: speaker fees from Eli Lilly
    VV: speaker fees from Galapagos
    FI: speaker fees from Abbvie, Eli Lilly, Galapagos, Pfizer
    FRS: speaker fees from Abbvie, Eli Lilly, Galapagos; research grant from Pfizer