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