Skip to main content
. 2023 Jul 25;46(11):1049–1071. doi: 10.1007/s40264-023-01333-0

Table 1.

Summary of actions taken by key international regulatory bodies regarding JAKi use

Jurisdiction Regulatory body Date Relevant JAKi Action
United States Food and Drug Administration February 2021 [16] Tofacitinib, baricitinib, upadacitinib Boxed warning for MACE, malignancy, and mortality with recommendation for the use of JAKi in moderately to severely active RA with an inadequate response or intolerance to TNF blockers
European Union European Medicines Agency March 2023 [18] Tofacitinib, baricitinib, upadacitinib, filgotinib, abrocitinib Recommendation for the use of JAKi across all approved indications in inflammatory and dermatologic diseases only if no suitable alternative treatments available for patients with the following risk factors:
  Age ≥ 65
  Increased risk of cardiovascular disease
  Current or past long-time smoking
  Increased risk of cancer
United Kingdom Medicines and Healthcare products Regulatory Agency April 2023 [148] Tofacitinib, baricitinib, upadacitinib, filgotinib, abrocitinib Recommendation for the use of JAKi only if no suitable alternative treatments available for patients with the following risk factors:
  Age ≥ 65
  Current or past long-time smoking
  Other risk factors for cardiovascular disease or malignancy
Canada Health Canada October 2022 [157] Tofacitinib, baricitinib, upadacitinib, filgotinib, abrocitinib Recommendation to consider the benefits and risks of JAKi for the individual patient, particularly for patients with the following risk factors:
  Above 65 years of age
  Current or past smokers
  Other cardiovascular or malignancy risk factors
   Underlying malignancy or those who develop a malignancy
   Increased risk of thrombosis
Australia Therapeutic Goods Administration May 2023 [158] Tofacitinib, baricitinib, upadacitinib Boxed warning and recommendation for the use of JAKi only if no suitable treatment alternatives are available for patients with the following risk factors:
  History of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers)
  Malignancy risk factors (such as currently malignancy or history of malignancy)
  Age ≥ 65

JAKi JAK (Janus kinase) inhibitors, MACE major adverse cardiovascular events, RA rheumatoid arthritis