EMA Recommends Limiting JAK Inhibitor Use

November 1, 2022

Older people, smokers and those with an increased risk of cardiovascular problems shouldn’t use Janus kinase inhibitors for chronic inflammatory diseases unless there are no other suitable treatment options, according to new recommendations by the European Medicines Agency (EMA).

The warning covers Pfizer’s Cibinqo (abrocitinib), Gilead Sciences’s Jyseleca (filgotinib), Eli Lilly’s Olumiant (baricitinib), AbbVie’s Rinvoq (upadacitinib) and Pfizer’s Xeljanz (tofacitinib). These drugs are indicated for chronic inflammatory illnesses, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis and alopecia areata.

The warning comes after the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed safety data on the drugs.

PRAC recommended that JAK inhibitors be used cautiously, if at all, in patients who are age 65 years and older, those at increased risk of major cardiovascular problems, past and current smokers or with a history of cancer.

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