The Xeljanz safety study final findings from the so-called “ORAL Surveillance” trial ordered by the FDA 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.
For more detail, the January 27, 2022 edition of the New England Journal of Medicine (NEJM) has this article, “Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis”, which reports all of the final data for this ORAL Surveillance Xeljanz safety study.
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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