Xeljanz Heart Risks May Be Similar Across Other JAK Inhibitors Like Rinvoq, Oluminant: Study

More research is needed into the link between Xeljanz and heart problems to determine how much of the risk is caused by side effects of the drugs, or the condition they are designed to treat, the researchers note

Following recent FDA warnings about the potential link between side effects of Xeljanz and heart problems, the findings of a new study suggests that if the rheumatoid arthritis drug carries heart and blood clot risks, those risks are likely uniform across the entire class of medications, which also includes widely marketed drugs like Rinvoq and Oluminant.

Xeljanz (tofacitinib) was intrtoduced by Pfizer in 2012, as the first member of a new class of medications, known as JAK inhibitors, which generate billions in sales for treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

According to a study published this month in JCR: The Journal of Clinical Rheumatology, Portuguese researchers suggest that most, if not all, JAK inhibitors carry a similar risk of major adverse cardiovascular events (MACE) and blood clots. However, the researchers were unable to confirm whether the drugs increased those heart risks, as suggested by an FDA label warning added to the drugs in September.

In a drug safety communication issued that month, the FDA indicated it had completed a review of the Xeljanz heart risks, evaluating data from a large randomized clinical trial that found users of the drug experienced more cardiovascular events, as well as cancers, pulmonary embolism and death. As a result of the findings, the agency issued a warning for users of Xeljanz, as well as all other drugs in the same new class of medications as well.

In this latest study, researchers examined data from 42 randomized controlled trials, looking at the safety and efficacy of Xeljanz and similar drugs when used by rheumatoid arthritis patients. They looked at the risks of major adverse cardiovascular events, venous thromboembolic events, and any other heart-related problems.

According to their findings, the researchers discovered the heart and blood clot risks of the drugs were so comparable that the differences between them were statistically insignificant, particularly when it came to heart problems such as heart attacks and heart disease. However, they were unable to determine whether the drugs were increasing those heart risks, or if they were the by-product of the rheumatoid arthritis the drugs were designed to treat.

The researchers called for more studies to be conducted on the new class of drugs, in order to clarify the relative risks of heart and blood clot health effects, in order to support future clinical decision-making, noting that inflammation from rheumatoid arthritis itself increased the risks of heart and blood clot problems in ways similar to what could be blamed on Xeljanz and its competitors.

“According to the current evidence, JKIs present a similar risk of cardiovascular and venous thromboembolism in the treatment of patients with rheumatoid arthritis,” the researchers concluded. “Postmarketing pharmacovigilance evidence will be of utmost importance in assessment of the comparative cardiovascular profile between the JKIs.”

After Xeljanz was introduced, Pfizer aggressively marketed the drug, joining a lucrative market for rheumatoid arthritis treatments, which already included blockbuster drugs like Humira, Enbrel and other similar medications, known as tumor necrosis factor (TNF) inhibitors. Xeljanz was advertised as a safer and more convenient treatment option, and quickly grew to become a top selling drug, with annual sales of more than $2 billion worldwide. However, data from a recently completed study raised questions about serious Xeljanz side effects that were not adequately described on the drug’s warning label.

In February 2021, the FDA issued a safety communication about a potential link between Xeljanz and cancer, heart attacks and other cardiovascular heart risks, following a preliminary review of data from a recently completed post-marketing study.

The FDA warning requirements come following months of speculation after the agency held up approval of other JAK inhibitors, requiring more study data from the manufacturers.

In June, Abbvie announced expanded approval for Rinvoq was being held up due to similar problems. Before that, in April, Pfizer announced the review for its new oral JAK inhibitor, abrocitinib, had been extended by three months due to the same concerns.

In July, media reports indicated Lilly and Incyte also announced the FDA delayed approval of Olumiant; a rheumatoid arthritis drug seeking expanded approval as an Eczema treatment. It has already been approved to treat the skin condition in 40 countries.

The study behind the FDA’s Xeljanz concerns was initially launched in January 2012, and given the long latency period for many cancers, many users now face concerns they require on-going medical monitoring to detect and diagnose cases in the future.

Former users are now contacting lawyers who are investigating Xeljanz lawsuits and class action claims, to seek additional information which has not been disclosed and compensation for treatments they may now require.