Xeljanz Heart and Cancer Concerns May Be Impacting FDA Review of Rinvoq for Psoriatic Arthritis

Amid recent concerns that side effects of Xeljanz may increase the risk of cancer and heart problems, federal regulators have delayed their review of another similar rheumatoid arthritis drug from the same class, Rinvoq, which is being considered for expanded approval to treat psoriatic arthritis.

Xeljanz (tofacitinib) and Rinvoq (upadacitinib) are both part of the same class of medications, known as Janus kinase (JAK) inhibitors, which work in similar ways, blocking the activity of certain enzymes in the body that affect the immune system function and inflammatory response.

After it was approved as the first JAK inhibitor in 2012, Xeljanz quickly became a blockbuster treatment, generating revenue in excess of $55 billion per year for Pfizer. The drug was initially approved for treatment of rheumatoid arthritis, but has since been extended for treatment of psoriatic arthritis in 2017, and severe active ulcerative colitis in 2018. However, there are now increasing concerns about the safety of the drug, and whether it was adequately researched before being widely marketed.

AbbVie introduced Rinvoq, which was approved in August 2019, for treatment of adult patients with moderate-to-severe rheumatoid arthritis. However, the drug maker has been pushing for additional indications, seeking approval from the FDA to market the drug for psoriatic arthritis as well.

While the FDA review process was ongoing for Rinvoq, the drug regulatory agency issued a new warning about cancer and heart problems from Xeljanz last month, indicating that an initial analysis of a recently completed post-marketing trial involving the JAK inhibitor found higher rates of cancer and major cardiovascular events compared to use of medications from an older class of rheumatoid arthritis drugs, known as TNF inhibitors, which included Humira and Enbrel.

The FDA indicated at that time the agency was continuing to evaluate the risk of cancer, heart attacks, strokes and other potential side effects identified in the study, and there has been speculation whether a Xeljanz recall or other restrictions may be required for the medication.

In a press release issued on March 17, AbbVie announced the FDA has now extended its review period for the request to approve Rinvoq for additional indications, raising concerns that the Xeljanz risks may impact other JAK inhibitors as well.

Xeljanz Cancer and Heart Risks

Concerns about the link between Xeljanz and cancer, heart attacks, strokes and other cardiovascular problems were identified as part of post-marketing study required by the FDA in 2012, comparing use of two different doses of Xeljanz to use of an older class of rheumatoid arthritis drug, known as TNF inhibitors. The study included 4,362 subjects who were 50 years or older, with at least one cardiovascular risk.

Preliminary data from the study released in 2019 had already identified an increased risk of pulmonary embolism with Xeljanz, when the 10 mg twice daily dose of the medication was used. As a result of those findings, the FDA required the drug maker to add a “black box” warning a few months later, which is the strongest label warning a prescription drug can be required to carry.

While the study was recently completed, full data has not been released or independently reviewed. However, an analysis by the drug maker, Pfizer, found an increased risk of serious heart-related problems and cancer among Xeljanz users. Specific types of cancer identified in the study have not been disclosed, but Pfizer did indicate that lung cancer was one of the most commonly reported.

A growing number of former users are now considering Xeljanz lawsuits against Pfizer, indicating that the new-generation JAK inhibitor was no better than older rheumatoid arthritis drugs, yet exposed users to serious and potentially life-threatening health risks that should have been disclosed.