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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

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.

In focus

Feature article

JAK inhibitor safety: Distilling the evidence

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

Safety snapshot

Upadacitinib in patients with psoriatic arthritis

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

ACR Convergence 2020 news

‘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.

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.

07-02-2022 | Gallery

Timeline of JAK inhibitor approvals for rheumatic diseases in the USA and Europe

07-02-2022 | Download | PNG 1.1 MB

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Related news

31-03-2022 | Rheumatoid arthritis | News

Real-world study suggests similar effectiveness of tofacitinib, TNF inhibitors

Findings from a rheumatoid arthritis registry study suggest that the JAK inhibitor tofacitinib may have comparable real-world effectiveness to TNF inhibitors.

14-01-2022 | Rheumatoid arthritis | News

JAK inhibitors may increase cholesterol in people with RA

Treatment with any of the five JAK inhibitors approved for use in rheumatoid arthritis in the USA, Europe, or Japan may lead to an increase in serum cholesterol levels, suggest results of a systematic review and network meta-analysis.

20-12-2021 | Ankylosing spondylitis | News

Tofacitinib given restricted FDA approval for ankylosing spondylitis

Click through for additional information on this announcement

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