Eli Lilly-Funded Study Claims Side Effects of Olumiant Do Not Warrant Same Adverse Label Warnings as Xeljanz

Study claims heart risks with Olumiant are the same as those of rheumatoid arthritis patients not taking the drug, raising questions about a class-wide warning after concerns about the side effects of Xeljanz emerged

After federal regulators identified an increased risk of cancer and heart attacks with Xeljanz, a boxed warning was added to all rheumatoid arthritis drugs from the same class. However, the findings of a new study funded by the drug maker Eli Lilly seems to suggest that side effects of Olumiant do not pose the same risks.

Xeljanz (tofacitinib) and Olumiant (baricitinib) are both part of the same new class of medications, known as JAK inhibitors, which are prescribed to tamp down overactive immune system and ease joint pain associated with rheumatoid arthritis. The class also includes Rinvoq (upadacitinib), and the medications have quickly grown to become blockbuster drugs and widely recognized brands, amid direct-to-consumer advertising.

In September, the U.S. Food and Drug Administration (FDA) announced a new “black box” warning for Xeljanz, Olumiant and Rinvoq, requiring all manufacturers of JAK inhibitors to include information about an increased risk of heart attacks, strokes, cancer, blood clots and death, following a review of data from a large randomized clinical trial involving Xeljanz, which was the first member of this class to hit the market.

Eli Lilly has now issued a press release regarding the findings of a clinical trial involving it’s product, Olumiant, claiming that the risk of major adverse cardiac events (MACE) was similar to those of rheumatoid arthritis patients who did not take the drug, even if they took Olumiant for nearly 10 years.

The findings were published late last month in the Annals of the Rheumatic Diseases, and were presented last week at the American College of Rheumatology’s virtual annual meeting.

Researchers conducted a pooled analysis involving ten different studies, which included data on 3,770 patients who received the drug. According to the findings, the risk of heart problems with Olumiant was 0.51 per 100 patient years of use. The manufacturer claims that is about the same as the general population of those with rheumatoid arthritis, suggesting taking Olumiant for up to 9.3 years carries no additional heart risks.

The findings also indicated that there was an increased risk of MACE for patients over the age of 50 who had at least one pre-existing condition which put them at risk of heart problems. Then the incidence rate increased to 0.77 per 100 patient-years.

These findings were released just before the results of an independent study which found that heart risks were essentially the same across all JAK inhibitors, including Olumiant.

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The FDA warning requirements came following months of speculation after the agency held up approval of other JAK inhibitors, requiring more study data from the manufacturers.

In June, Abbvie announced expanded approval for Rinvoq was being held up due to similar problems. Before that, in April, Pfizer announced the review for its new oral JAK inhibitor, abrocitinib, had been extended by three months due to the same concerns.

In July, media reports indicated Lilly and Incyte also announced the FDA delayed approval of Olumiant; a rheumatoid arthritis drug seeking expanded approval as an Eczema treatment. It has already been approved to treat the skin condition in 40 countries.

The study behind the FDA’s Xeljanz concerns was initially launched in January 2012, and given the long latency period for many cancers, many users now face concerns they require on-going medical monitoring to detect and diagnose cases in the future.

Former users are now contacting lawyers who are investigating Xeljanz lawsuits and class action claims, to seek additional information which has not been disclosed and compensation for treatments they may now require.

The FDA is still working on the language for the new label warnings for Xeljanz and Olumiant. It is unclear whether Eli Lilly will attempt to use the study’s findings to mitigate or avoid that label warning for Olumiant.


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