January 2022 Medical Journal Article Presents Full Set of Findings for the Xeljanz "ORAL Surveillance" Trial Which Started in 2014
(Posted by Tom Lamb at Drug Injury Watch)
One year ago Pfizer released some preliminary results from the so-called "ORAL Surveillance" trial ordered by the FDA when Xeljanz (tofacitinib) was first approved for rheumatoid arthritis in 2012, and which started in 2014. In part, those early Xeljanz safety findings involved data about increased risks of cancer and heart-related side effects, which the FDA also considers applicable to Rinvoq and Olumiant, other medicines in the JAK inhibitors drug class.
In the January 27, 2022 edition of the New England Journal of Medicine (NEJM), there was this article, "Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis", which reported the final results of the ORAL Surveillance trial. In that same January 2022 NEJM edition there was an editorial piece, "Risks and benefits of Janus kinase inhibitors in rheumatoid arthritis -- past, present, and future", that discussed the significance of those Xeljanz safety findings.
The final results from this ORAL Surveillance Xeljanz safety study were examined in this January 26, 2022 article, "Trial Data Confirm Heightened Risks With JAK Inhibitor", by medical news reporter John Gever for MedPage Today.
That January 2022 MedPage Today news report provides a "snapshot" of the current safety profile for Xeljanz as regards cancer and heart-related side effects:
It's official: full data from a randomized trial evaluating safety of the oral JAK inhibitor tofacitinib (Xeljanz), approved for treating rheumatoid arthritis and related disorders as well as ulcerative colitis, are now published -- and they are not good.
Patients assigned to [Xeljanz] developed major adverse cardiovascular events (MACE) at a rate of 3.4% and new cancers were seen in 4.2% during a median 4 years of follow-up; for those treated with either adalimumab (Humira) or etanercept (Enbrel), the corresponding rates were 2.5% and 2.99%, respectively, according to a report in the New England Journal of Medicine.
This worked out to hazard ratios of 1.33 for MACE (95% CI 0.91-1.94) and 1.48 for incident cancers (95% CI 1.04-2.09), reported investigators led by Steven Ytterberg, MD, of the Mayo Clinic in Rochester, Minnesota....
In their paper, Ytterberg and colleagues stuck to reporting the trial's results, offering no advice to patients or clinicians on how to interpret them.
That was left to editorialist Jasvinder Singh, MBBS, MPH, of the University of Alabama at Birmingham. He noted that the drug -- along with its chemical cousins baricitinib (Olumiant) and upadacitinib (Rinvoq) -- already come with boxed warnings about the risk, which were stiffened again just last month. The agency also tightened eligibility criteria for [Xeljanz] and [Rinvoq] to allow the drugs only in patients failing on TNF inhibitors; previously, patients could receive them after failing nonbiologic drugs.
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Taking into account the above new information about Xeljanz safety findings, to date some of the serious side effects and adverse drug events that have been associated with Xeljanz, Rinvoq, and Olumiant are:
Myocardial Infarction (MI)
Strokes — Ischemic / due to a blood clot
Deep Vein Thrombosis (DVT)
Pulmonary Embolism (PE)
Our law firm is investigating possible Xeljanz, Rinvoq, and Olumiant lawsuits for patients who have suffered any of these serious side effects or adverse drug reactions. We would like to help you or someone you know with a Xeljanz, Rinvoq, or Olumiant drug injury case. Please feel free to contact us, at your convenience.
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