Cancer Risk with Xeljanz, Other JAK Inhibitors Higher Than Among Users of Older TNF Inhibitors

Although a series of Janus Kinase (JAK) inhibitor medications have been introduced in recent years as new treatments for rheumatoid arthritis, including Xeljanz, Rinvoq, Olumiant and others, there are growing concerns about the cancer risks associated with the new generation drugs, especially when compared to older tumor necrosis factor (TNF) inhibitor drugs, which include the blockbuster treatments like Humira, Enbrel and others.

Xeljanz (tofacitinib) was introduced by Pfizer as the first JAK inhibitor in 2012, joining the lucrative market for treatments of individuals with rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. The drug was considered revolutionary, and quickly gained the upper-hand on alternative TNF inhibitors, which are administered by shot or infusion.

As more data has become available, concerns about potential Xeljanz cancer risks and other side effects began to emerge in early 2021, after preliminary data from a post-marketing study linked Xeljanz to an increased risk of cancer, heart attacks, strokes and deadly blood clots.

These findings have resulted in a number of Xeljanz lawsuits being filed by former users diagnosed with cancer and other injuries, alleging that drug makers failed to adequately research the side effects of JAK inhibitors and warn about potential risks compared to older TNF inhibitors.

2023 Study Links Xeljanz to Increased Cancer Risks

In a new meta-analysis recently presented at the British Society for Rheumatology (BSR) 2023 Annual Meeting, researchers found that JAK inhibitors like Xeljanz appear to be associated with a higher risk for cancer when compared to those taking tumor necrosis factor (TNF) inhibitor drugs.

Researchers reviewed data from 62 randomized controlled trials and 14 long-term extension studies, accounting for 82,366 patient years. This included 71,767 person-years of exposure to JAK inhibitors, 7,827 to TNF inhibitors, 1,074 to MTX and 2,680 to placebo.

The JAK inhibitors reviewed in the meta-analysis included Xeljanz, baricitinib (Olumiant), upadacitinib (Rinvoq), filgotinib (Jyseleca), and peficitinib (Smyraf).

Researchers performed sensitivity analyses omitting cancers diagnosed within the first six months of treatment, to determine whether there was a higher rate of cancer diagnosis among JAK inhibitor recipients than those receiving placebo, TNF inhibitors, or methotrexate.

While JAK inhibitors were not found to be associated with an increased risk of cancer when compared to MTX or placebo groups, researchers did identify a significant risk when comparing JAK and TNF inhibitor users.

When compared to TNF inhibitor use, researchers found Xeljanz and other JAK inhibits were associated with a 54% higher incidence of cancer, citing an incident rate ratio of 1.54, along with 95% confidence interval from 1.19 to 2.01 (p=0001).

FDA Mandated Xeljanz Cancer Warning Label Update

In a drug safety communication issued in September 2021, the U.S. Food and Drug Association (FDA) announced a Xeljanz warning label update, after data from a large randomized clinical trial suggested that users were more likely to experience serious heart problems and cancer compared to older rheumatoid arthritis drugs. Since then, those concerns have spread to other JAK inhibitors as well, including Rinvoq and Olumiant.

In the months to follow, AbbVie announced a Rinvoq cancer warning label update on December 3, stating its intent to update the U.S. Prescribing Information and Medication Guide for the JAK inhibitor drug. The warning press release cited the recent data about the risk of heart attacks, strokes, cancer, blood clots and death as the reasoning for its warning label update.

May 2023 Xeljanz Lawsuit Update

Dozens of Xeljanz lawsuits are currently being pursued by former users diagnosed with cancer, heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other cardiovascular injuries.

Although each of the complaints raise similar questions of fact and law, there are not currently any consolidated pretrial proceedings in the federal court system, and each of the lawsuits is moving forward on an individual tract.

The number of lawsuits are projected to grow throughout 2023 as Xeljanz lawyers continue to investigate and file new claims for individuals who took Xeljanz and Xeljanz XR, or any of the JAK inhibitor drugs and suffered;

• Pulmonary Embolism (PE)
• Deep Vein Thrombosis (DVT)
• Ischemic or Embolic Stroke (do not accept mini-strokes)
• Heart Attack
• Cancer or Lymphoma Diagnosis
• Hospitalization due to another blood clot injury