AbbVie Updates Upadacitinib Prescription Guidelines Amidst Safety Concerns

AbbVie recently announced an amendment to the US Prescribing Information and Medication Guide for upadacitinib. The drug, a selective Janus kinase (JAK) inhibitor, now states that it is intended for adults with moderate-to-severe rheumatoid arthritis (RA) who have had inadequate response or intolerance to at least 1 tumor necrosis factor (TNF) blocker.

In September, the US Food and Drug Administration (FDA) expressed safety concerns about JAK inhibitors based on the results of the ORAL Surveillance study, which indicated an increased risk of major adverse cardiac events (MACE), mortality, malignancy, and thrombosis in patients with RA receiving fellow JAK inhibitor, tofacitinib (Pfizer).

Results showed that 3.37% of patients receiving tofacitinib had a major cardiovascular event during the study period, compared with 2.55% of those given a TNF. Further, non-melanoma skin cancer and other malignancies were seen in 4.19% of patients in the tofacitinib cohort, compared with 2.89% in the TNF inhibitor group.

Given that the 2 drugs work in a similar way, AbbVie will now include information about this risk, which includes cardiovascular death, myocardial infarction, and stroke on its Boxed Warnings and Warnings and Precautions sections. The drug has not been tested in children under 18 years of age.

Upadacitinib, approved for moderate-to-severe RA in August 2019, exhibited greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2 and is currently undergoing Phase 3 trials for psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, atopic dermatitis, Chron’s disease, giant cell arteritis, and Takayasu arteritis.

Since its launch in 2013, the biopharmaceutical company has invested approximately $50 billion in discovering and developing medicines focused on treating diseases with significant unmet need.

"RINVOQ [upadacitinib] 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," stated AbbVie vice chairman and president, Michael Severino, MD.