FDA expands JAK inhibitors warning: going beyond the data?

Abstract

On Sept 1, 2021, the US Food and Drug Administration (FDA) issued a Drug Safety Communication regarding the use of tofacitinib and two other JAK inhibitors used in the treatment of rheumatoid arthritis and other immune-mediated diseases, upadacitinib and baricitinib. The Communication updates a previous statement issued in February, 2021, and follows the FDA's full review of data from the ORAL Surveillance post-marketing study, which failed to demonstrate the non-inferiority of tofacitinib to TNF inhibitors in terms of major adverse cardiovascular events (MACE) and malignancies in patients with rheumatoid arthritis aged 50 years or older with at least one additional cardiovascular risk factor. The FDA has concluded that tofacitinib increases the risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death, and requires revisions to the boxed warning for all three drugs. Approved use of these drugs will now be limited to patients who have not responded to or cannot tolerate one or more TNF inhibitors.