Risk of venous thromboembolism with tofacitinib versus tumor necrosis factor inhibitors in cardiovascular risk-enriched rheumatoid arthritis patients

Arthritis Rheumatol 2024 doi: 10.1002/art.42846 Epub ahead of print https://pubmed.ncbi.nlm.nih.gov/38481002/

This post hoc analysis of ORAL Surveillance showed that incidence of venous thromboembolism (VTE) events was higher in patients with RA treated with tofacitinib (10>5mg BID) versus TNFi. Across treatments, VTE risk factors (age, BMI, and VTE history) were aligned with previous studies in the general RA population.

December 2023

Post hoc analysis of ORAL Surveillance data highlights that active disease in RA leads to higher risk of adverse medical events, regardless of medication used.

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July 2023

Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.

June 2023

JAK Inhibitors and the Risk of Malignancy: A Meta-analysis Across Disease Indications

Ann Rheum Dis. 2023;82(8):1059–1067 doi: 10.1136/ard-2023-224049

The objective of this study was to estimate the association of JAKi with the incidence of malignancy, compared with placebo, TNFi and MTX.

April 2023

Findings from a post hoc analysis of ORAL Surveillance can help guide individualised benefit/risk assessment and clinical decision-making on treatment with tofacitinib, based on identification of subpopulations ‘at risk’.

March 2023

Integrated analysis of the safety profile of upadacitinib demonstrates that it was generally well-tolerated in RA, PsA, AS and AD, with no new safety risks identified, compared with previous reports.

Results from the open-label, randomised controlled ORAL Surveillance trial find increased risk of malignancies with tofacitinib versus TNFi, highlighting the highest incidence in patients with a history of atherosclerotic cardiovascular disease or increasing cardiovascular risk.

February 2023

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

December 2022

Weitz, et al. analyse 291 protein biomarkers and three genetic markers and do not identify a clear mechanistic explanation for higher rates of venous thromboembolism (VTE) with tofacitinib in the ORAL Surveillance study.

November 2022

Large, population-based, real-world cohort of study in patients with RA finds tofacitinib not to be associated with an increased risk of malignancies, in comparison to TNFi agents, although a numerically increased risk of malignancies was observed in older patients with risk factors for cardiovascular disease.