NETHERLANDS —The European Medicines Agency’s (EMA) safety committee (PRAC) has recommended measures to reduce the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat a variety of chronic inflammatory disorders.

These side effects include cardiovascular conditions, blood clots, cancer, and serious infections.

The Committee recommended that these medicines be used only in the following patients if no other options are available: those aged 65 or older, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have smoked in the past, and those at increased risk of cancer.

The Committee also cautioned against using JAK inhibitors in patients with risk factors for blood clots in the lungs and deep veins (venous thromboembolism, VTE).

The recommendations are the result of an analysis of available data, which included the final results of a clinical trial1 of the JAK inhibitor Xeljanz (tofacitinib) and preliminary findings from an observational study involving Eli Lilly’s Olumiant Olumiant (baricitinib), another JAK inhibitor.

According to the review findings, Xeljanz increases the risk of major CV problems, cancer, venous thromboembolism (VTE), serious infections and death from any cause when compared to TNF-alpha inhibitors.

Other JAKs subject to the review were Cibinqo (abrocitinib), which is also marketed by Pfizer; AbbVie’s Rinvoq (upadacitinib); and Gilead Sciences and Galapagos’ Jyseleca (filgotinib).

The PRAC sought advice from an expert group of rheumatologists, dermatologists, gastroenterologists, and patient representatives during the review.

PRAC has also concluded that this applies to all approved uses of JAK inhibitors in chronic inflammatory disorders such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis, and alopecia areata.

Furthermore, in some patient groups who are at risk of VTE, cancer, or major cardiovascular problems, the doses should be reduced.

The new recommendations and warnings will be added to the product information for JAK inhibitors used to treat chronic inflammatory disorders.

Furthermore, educational materials for patients and healthcare professionals will be revised. Patients who have concerns about their treatment or the possibility of serious side effects should consult their doctor.

Meanwhile, JAK inhibitors including Novartis’ Jakavi (ruxolitinib) and Bristol Myers Squibb’s Inrebic (fedratinib) prescribed for myeloproliferative disorders were not included in PRAC’s review, nor was the use of Olumiant for the short-term treatment of COVID-19, which is being evaluated by the EMA.

The PRAC advice comes on the heels of a similar move by US regulators. After concluding that there was an increased risk of serious cardiac-related events such as heart attack or stroke, cancer, blood clots, and death, the FDA updated warnings and tightened restrictions on drugs in the JAK class last year.

Boxed warnings for JAKs used to treat chronic inflammatory conditions were updated, and the drugs were restricted to patients who had not responded to or could not tolerate TNF blockers.

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