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JAK inhibitor safety

Weighing up the data and understanding the risks

What you need to know

A number of JAK inhibitors are now approved for the treatment of rheumatic diseases in different settings, but questions remain about their long-term safety profiles and overall place in therapy.

Take a look below for in-depth discussion of the potential risks associated with JAK inhibitors and what these mean for rheumatologists, as well as news on the latest safety data and approvals for this class of drugs.

Research news

ORAL Surveillance: Tofacitinib fails to show noninferiority vs TNF inhibitors for MACE, malignancy risk

Question mark illustration

The JAK inhibitor tofacitinib is associated with numerically higher rates of MACE and malignancy than TNF inhibitors in people with RA at high CV risk, show the ORAL Surveillance results.

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Feature article

JAK inhibitor safety: Distilling the evidence

Approval timeline

Peter Nash discusses the latest evidence on the association between JAK inhibitors and the risk for VTE, MACE, and malignancy.

‘The Great Debate’: JAK inhibitors vs biologics following methotrexate failure in RA

“The Great Debate” of the ACR Convergence 2020 virtual meeting addressed the question of whether JAK inhibitors should be given before biologics following an inadequate response to methotrexate in patients with rheumatoid arthritis.

Safety snapshot: Upadacitinib in patients with psoriatic arthritis

Access our overview of the key safety data from the SELECT-PsA studies.

Regulatory updates

FDA requires boxed warning updates for JAK inhibitors

The US FDA has issued an updated safety communication announcing that boxed warnings on the labels for tofacitinib, baricitinib, and upadacitinib must be updated to include information on the risk for serious cardiovascular events, cancer, blood clots, and death.

EMA gives nod to upadacitinib for psoriatic arthritis, ankylosing spondylitis

The EMA’s Committee for Medicinal Products for Human Use has recommended that the indication for upadacitinib should be expanded to include psoriatic arthritis and ankylosing spondylitis.

Related news

11-11-2021 | ACR 2021 | Conference coverage | News

Real-world study suggests no elevated CV risk with tofacitinib in overall RA population

Tofacitinib is not associated with a higher risk for cardiovascular outcomes than TNF inhibitors in the overall population of people with rheumatoid arthritis, suggest findings from a US database study.

10-11-2021 | ACR 2021 | Conference coverage | News

ORAL Surveillance: Tofacitinib fails to show noninferiority vs TNF inhibitors for MACE, malignancy risk

The JAK inhibitor tofacitinib is associated with numerically higher rates of MACE and malignancy than TNF inhibitors in people with rheumatoid arthritis at high cardiovascular risk, show the ORAL Surveillance results.

02-09-2021 | JAK inhibitors | News

FDA requires boxed warning updates for JAK inhibitors

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