FDA Requires Warnings on Labels of JAK Inhibitors for Inflammatory Conditions

The FDA is requiring revisions about increased risk of serious heart-related events such as heart attack, stroke, cancer, blood clots and death to the labels of Pfizer Inc.’s Xeljanz/Xeljanz XR (tofacitinib), Eli Lilly and Co.’s Olumiant (baricitinib) and AbbVie Inc.’s Rinvoq (upadacitinib) following the agency’s review of a large, randomized safety clinical trial of Xeljanz. The trial compared Xeljanz with tumor necrosis factor (TNF) inhibitors in people with rheumatoid arthritis and showed an increased risk of blood clots and death with a lower dose of Xeljanz. A prior study whose results Pfizer disclosed on Jan. 27, 2021, showed the same results but only at a higher dose.

The FDA initially approved Xeljanz on Nov. 6, 2012, for the treatment of rheumatoid arthritis. It’s now approved for four inflammatory conditions, including psoriatic arthritis.

While Olumiant and Rinvoq were not studied, they are also Janus kinase (JAK) inhibitors indicated for inflammatory conditions, so the FDA says they might have similar risks. The agency also is limiting all of the drugs’ approved uses to people who have not responded to or cannot tolerate one or more TNF inhibitors.

The FDA noted that it had approved two other JAK inhibitors — Incyte Corp.’s Jakafi (ruxolitinib) and Bristol Myers Squibb’s Inrebic (fedratinib) — but because they are not indicated for an inflammatory condition, they do not have to update their prescribing information.

For the Managed Care Biologics and Injectables Index: Q2 2021, between May 18, 2021, and July 13, 2021, Zitter Insights polled 40 commercial payers with 129.5 million covered lives about the prior study and its impact on their management of psoriasis and of the JAK/STAT inhibitors. Payers with almost 50% of covered lives said the study was highly influential (see chart).

Zitter Insights and AIS Health are both MMIT companies.

During the same time period, Zitter Insights polled 50 rheumatologists on how the study would impact their prescribing. They reported a higher impact than payers, with 64% saying it was highly influential on their psoriatic arthritis prescribing, and 56% said the same for JAK/STAT inhibitors.


For more information on the Zitter data, contact Jill Brown Kettler at jbrown@aishealth.com.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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