Xeljanz, Rinvoq, and Olumiant Are the Three Janus Kinase (JAK) Inhibitors Getting "Black-Box" Warnings Revisions, Soon
In September 2021 the FDA announced it was requiring revisions to the "Black-Box" warnings for Xeljanz, Rinvoq, and Olumiant to include information about the increased risk of various adverse drug reactions, including serious heart-related events, cancer, blood clots, and death. Xeljanz (tofacitinib), Rinvoq (upadacitinib), and Olumiant (baricitinib) are the three Janus kinase (JAK) inhibitors currently approved by the FDA for the treatment of arthritis and other inflammatory conditions. As such, this September 2121 FDA action can be characterized as a JAK inhibitors drug class label change.
For more information about the basis for that JAK inhibitors drug class label change, we point out an excerpt from this September 2021 document, "FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions":
We are requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase (JAK) inhibitors, Olumiant (baricitinib) and Rinvoq (upadacitinib). Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated. However, since they share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.
As background, Xeljanz is a Pfizer drug, Rinvoq is an AbbVie drug, and Olumiant is an Eli Lilly drug. Not surprisingly, the pharmaceutical companies AbbieVie and Eli Lilly have attempted to distinguish the safety profile of their respective JAK inhibitors drug product from the various adverse drug reactions that have been observed in the Xeljanz clinical trial referenced by the FDA, above.
For example, there is this Lilly News Release document, "OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis", which was issued on November 9, 2021.
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For some analysis and context about that November 2021 Olumiant press release from Eli Lilly, we refer you to this Fierce Pharma news report, "Eli Lilly touts long-term safety data for Olumiant amid classwide scrutiny on JAK meds", published on November 10, 2021. In part, the article dissects a pooled analysis across nine clinical trials -- and one long-term extension study -- in rheumatoid arthritis patients who received Olumiant for up to 9.3 years, which was presented by Eli Lilly at the recent American College of Rheumatology annual meeting.
In the new pooled analysis, the incidence of major adverse cardiovascular events (MACE) for Olumiant was 0.51 per 100 patient-years of exposure, which Lilly said falls within the range in the general rheumatoid arthritis population as described in epidemiological studies. The analysis covered 3,770 patients taking Olumiant at 4 mg and 2 mg doses for a median of 4.6 years.
In a subgroup of patients over 50 years old who had at least one existing heart risk factor, the incidence rate of MACE was higher at 0.77 per 100 patient-years.
That latter patient population was targeted in Pfizer’s postmarketing safety study for Xeljanz. As the New York pharma disclosed earlier this year, Xeljanz’s MACE incidence rate was 0.91 per 100 person-years at the 5 mg dose, compared with 0.73 for TNF blockers. The difference translated into an increased risk of 24% for Xeljanz.
As for the cancer rates, the age-adjusted number for Olumiant was 0.92 per 100 person-years, which Lilly again said appeared similar to the general U.S. population. In the Pfizer trial, Xeljanz recorded a cancer rate of 1.13, compared with 0.77 for TNF inhibitors.
While Eli Lilly, AbbieVie, and Pfizer are jockeying for the future market share of Olumiant, Rinvoq, and Xeljanz as treatments for arthritis and other inflammatory conditions, the FDA is still considering the details of the JAK inhibitors drug class "Black-Box" warnings label change it announced in September 2021.
Our law firm is investigating possible drug injury lawsuits for patients who used Olumiant, Rinvoq, or Xeljanz and then suffered one of the serious side effects associated with those JAK inhibitors drug by the FDA. In particular, heart problems such as heart attacks, strokes, pulmonary embolism (PE), and deep vein thrombosis (DVT), as well as cancers such as lymphoma and lung cancer. Feel free to contact us if we can be of assistance to you or someone you know.
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