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’.

Retrospective cohort study found 15 501 PsO patients in the TriNetX database during January 2014–June 2022 that were prescribed bDMARDS, of which 6.3% developed inflammatory arthritis. 3.5% of all patients in the study specifically developed PsA.

TNF inhibitors (TNFi) are one main mode of therapy in patients with PsA who fail to respond to csDMARDs. However, they have a primary treatment failure rate of 40% and only a modest target of ≥20% ACR20 response. The objective of this study was to evaluate efficacy and safety of guselkumab, interleukin-23 inhibitor in the DISCOVER-1 study with active PsA patients by prior use of TNFi.

Ixekizumab, has been shown to be efficacious against paradoxical palmoplantar pustulosis which has been reported following the administration of therapeutic TNFi. Following the increased use of biologic therapies that improve patients’ quality of life are causing paradoxical adverse effects

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March 2023

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

This study demonstrated comparable drug retention between AS patients treated with alternative TNFi and secukinumab after failing to respond to prior TNFi therapy. The objective of this study was to compare the drug retention times and clinical efficacy of alternative TNFi and secukinumab in primary and secondary
non-responders with AS.

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

In this multi-centric, real-world study, persistence with secukinumab and TNFi were not statistically different for matched populations. The primary outcome of this analysis was drug persistence, calculated as the difference in months between initiation and discontinuation.

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.

Salinas, et al. evaluate baricitinib safety with respect to VTE, MACE, and serious infection relative to TNFi in patients with RA, in routine care and observe an increased risk of VTE in patients taking baricitinib, compared to TNFi.