EMA Reviews Safety of Janus Kinase Inhibitors to Treat Inflammatory Disorders

The European Medicines Agency (EMA) announced on Feb. 11, 2022 that its Pharmacovigilance Risk Assessment Committee (PRAC) has started a safety review of Janus kinase (JAK) inhibitors used to treat chronic inflammatory disorders, such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis, and atopic dermatitis. Final results from a clinical trial of the JAK inhibitor Xeljanz (tofacitinib), which showed that patients taking Xeljanz who were at risk for heart disease were more likely to experience cardiovascular problems, prompted the review.

The trial results also showed there was a higher risk of patients developing cancer when using Xeljanz than in those patients treated with TNF-alpha inhibitors. “The study also showed that compared with TNF-alpha inhibitors, Xeljanz was associated with a higher risk of death due to any cause, serious infections, and blood clots in the lungs and in deep veins (venous thromboembolism VTE),” the agency stated in a press release.

Preliminary findings in another study involving Oluminat (baricitinib), a JAK inhibitor, suggest an increased risk in cardiovascular problems in VTE patients treated with the drug, compared with those treated with TNF-alpha inhibitors.

“In the treatment of inflammatory disorders, Olumiant and other JAK inhibitors work in a similar way to Xeljanz. PRAC will therefore carry out a review to determine whether these risks are associated with all JAK inhibitors authorized in the EU for the treatment of inflammatory disorders and whether the marketing authorizations for these medicines should be amended,” the agency stated.

Source: EMA