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EMA Recommends Limiting the Indications for JAK Inhibitors

AMSTERDAM — In an effort to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended limiting the indications for which these medicines are used — namely chronic inflammatory disorders, such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis, and alopecia areata.

These side effects include cardiovascular conditions (primarily heart attack), blood clots, cancer (skin cancer), and serious infections (in particular, tuberculosis and shingles).

The PRAC recommended that these medicines be used in the following four patient groups only if no suitable treatment alternatives are available:

  • Those aged 65 years or older

  • Those at increased risk for major cardiovascular problems (such as heart attack or stroke)

  • Those who smoke or who have a long history of smoking

  • Those at increased risk for cancer

The PRAC also recommended using JAK inhibitors with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism) other than those listed above.

Furthermore, the doses should be reduced for patients who may be at risk for venous thromboembolism, cancer, or major cardiovascular problems, according to the PRAC.

The recommendations are based, in particular, on the final results from a clinical trial of the JAK inhibitor tofacitinib (Xeljanz), compared with a tumor necrosis factor (TNF) inhibitor, and on preliminary findings from an observational study involving baricitinib (Olumiant), another JAK inhibitor.

The PRAC’s review of available data confirmed that tofacitinib increases the risk of major cardiovascular problems, cancer, venous thromboembolism, serious infections, and death due to any cause, compared with TNF-alpha inhibitors.

The JAK inhibitors subject to this review were abrocitinib (Cibinqo), filgotinib (Jyseleca), baricitinib (Olumiant), upadacitinib (Rinvoq), and tofacitinib (Xeljanz). Some JAK inhibitors (ruxolitinib and fedratinib) are used to treat myeloproliferative disorders; the review did not include these medicines. The review also did not examine baricitinib for the short-term treatment of COVID-19, which is under assessment by the EMA.

If the European Commission adopts the EMA’s opinion at the end of the year, the product information for JAK inhibitors used to treat chronic inflammatory disorders will be updated with the new recommendations and warnings.

This article was translated from the Medscape French edition.

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