April 2024

Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: A post hoc analysis of a Phase 3b/4 randomised safety study

RMD Open 2024;10:e003912 doi: 10.1136/rmdopen-2023-003912

Risk of composite CV endpoints combining all ischaemic CV events and heart failure were similar for individual and combined TOF doses versus TNFi. The totality of CV risk (MACE-8 plus VTE) was higher with TOF 10mg twice daily versus TNFi. Buch et al conducted a post-hoc analysis on the ORAL Surveillance trial to assess risk across extended MACE endpoints in RA patients treated with either TOF 5mg, TOF 10mg, or TNFi.

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March 2024

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.

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February 2023

Impact of Cardiovascular Risk Enrichment on Incidence of Major Adverse Cardiovascular Events in the Tofacitinib Rheumatoid Arthritis Clinical Programme

Ann Rheum Dis. 2023;82(4):575–577 doi: 10.1136/ard-2022-223406

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

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October 2022

Risk of MACE with Tofacitinib Versus TNFi in Patients with RA With or Without a History of Atherosclerotic CV: A Post Hoc Analysis from ORAL Surveillance

Ann Rheum Dis. 2022. doi: 10.1136/ard-2022-222259

Post hoc analysis from ORAL Surveillance observes higher major adverse cardiovascular events (MACE) risk with tofacitinib vs TNFi in patients with RA and history of atherosclerotic cardiovascular disease (ASCVD).

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February 2022

Cardiovascular and Cancer Risk With Tofacitinib in Rheumatoid Arthritis

N Engl J Med 2022;386:316–26. doi: 10.1056/NEJMc2202778

In this paper, Ytterberg et al. compare incidence of MACE and cancers (excluding NMSC) with tofacitinib 5 mg BID, tofacitinib 10 mg BID and TNFi. They found that risk of MACE and cancer were higher with tofacitinib versus TNFi, and did not meet noninferiority criteria.This prospective head-to-head safety trial compared tofacitinib to TNFi, and was required by the FDA after increases in lipid levels and cancers were observed during tofacitinib drug development. ...

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