Rheumatoid Arthritis Disease Activity and Adverse Events in Patients Receiving Tofacitinib or Tumor Necrosis Factor Inhibitors: A Post Hoc Analysis of ORAL Surveillance
Ther Adv Musculoskelet Dis. 2023;15:1759720X231201047 doi: 10.1177/1759720X231201047
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.
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.
Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme
Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-223916
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.
Identification of Two Tofacitinib Subpopulations with Different Relative Risk Versus TNF Inhibitors: An Analysis of the Open Label, Randomised Controlled Study ORAL Surveillance
Ann Rheum Dis. 2023;82(7):901-910 doi: 10.1136/ard-2022-223715
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’.
Safety Profile of Upadacitinib over 15 000 Patient-years Across Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Atopic Dermatitis
RMD Open. 2023;9(1):e002735 doi: 10.1136/rmdopen-2022-002735
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.
Malignancy Risk with Tofacitinib versus TNF Inhibitors in Rheumatoid Arthritis: Results from the Open-Label, Randomised Controlled Oral Surveillance Trial
Ann Rheum Dis. 2023;82(3):331–343 doi: 10.1136/ard-2022-222543
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.
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).
Biomarkers to predict risk of venous thromboembolism in patients with rheumatoid arthritis receiving tofacitinib or tumour necrosis factor inhibitors
RMD Open. 2022;8(2):e002571 doi: 10.1136/rmdopen-2022-002571
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.
Tofacitinib and Risk of Malignancy: Results From the Safety of Tofacitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA) Study
Arthritis Rheumatol. 2022;74:1648–1659 doi: 10.1002/art.42250
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.
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).