AbbVie today announced an update to the U.S. Prescribing Information and Medication Guide for RINVOQ® (upadacitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). This update follows a Drug Safety Communication (DSC) issued on Sept. 1, 2021 by the U.S. Food and Drug Administration (FDA) following its final review of the post-marketing study, ORAL Surveillance, evaluating XELJANZ® (tofacitinib) in patients with RA.1 The results of this study showed a higher rate of major adverse cardiac events (MACE), malignancy, mortality and thrombosis in XELJANZ (a Janus kinase (JAK) inhibitor) versus TNF blockers.1 The DSC and this label update apply to the class of systemically administered FDA-approved JAKs indicated for the treatment of RA and other inflammatory diseases.1
Based on this class-wide update, the U.S. label for RINVOQ will now include additional information about the risks of malignancy and thrombosis, and the addition of mortality and MACE (defined as cardiovascular death, myocardial infarction and stroke) risks within the Boxed Warnings and Warnings and Precautions sections.1 The indication has also been updated to the following: RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.1
“RINVOQ is an important treatment option for people living with rheumatoid arthritis, especially those who have not been able to achieve remission or low disease activity. We remain committed to continue generating evidence that support its benefit-risk profile across many inflammatory conditions,” said Michael Severino, M.D., vice chairman and president, AbbVie.
Supplemental New Drug Applications (sNDAs) for upadacitinib (RINVOQ) in atopic dermatitis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis remain under review by the FDA.