tofacitinib - measures to minimise risk of major adverse cardiovascular events and malignancies

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Tofacitinib - measures to minimise risk of major adverse cardiovascular events and malignancies

Advice for healthcare professionals:

Information on cardiovascular events

  • a clinical safety trial in patients with rheumatoid arthritis aged 50 years or older with at least one cardiovascular risk factor (Study A3921133) found that the JAK inhibitor tofacitinib was associated with an increased risk of major adverse cardiovascular events compared with TNF-alpha inhibitors (etanercept or adalimumab)
  • the following predictive risk factors were identified:
    • age older than 65 years,
    • current or past smoking,
    • history of diabetes,
    • and history of coronary artery disease (including past myocardial infarction, coronary heart disease, stable angina pectoris, or coronary artery procedures)
  • only consider use of tofacitinib in patients with these cardiovascular risk factors, irrespective of indication, if no suitable treatment alternative is available
Information on malignancy
  • the same clinical safety trial in patients with at least one cardiovascular risk factor (some of which are also malignancy risk factors) found that tofacitinib was associated with an increased risk of malignancies (with the analysis excluding non-melanoma skin cancer [NMSC]), particularly lung cancer and lymphoma, compared with TNF-alpha inhibitors
  • the following predictive risk factors were identified:
    • age older than 65 years and
    • current or past smoking
  • only consider use of tofacitinib in patients with these and other malignancy risk factors (current or previous history of malignancy other than successfully treated NMSC), irrespective of indication, if no suitable alternative treatment is available
Advice for healthcare professionals to give to patients:
  • tofacitinib treatment has been associated with an increased risk of heart attacks and certain cancers compared with another type of treatment (TNF-alpha inhibitors) - the incidence of these events is low and they have been linked to existing risk factors for these conditions such as older age or smoking
  • patients who are already at increased risk of cardiovascular events or cancers should only be offered treatment with tofacitinib if their doctor feels there are no other suitable treatment options for their condition
  • do not stop taking tofacitinib without first talking to your doctor
  • always read the leaflet that accompanies your medicines and talk to your doctor, nurse, or pharmacist if you are concerned about any side effects

Reference:

  • Drug Safety Update volume 15, issue 3: October 2021: 1.

Last edited 10/2021 and last reviewed 10/2021