Background Rheumatoid arthritis (RA) is a systemic autoimmune inflammatory disease that affects the synovial membrane of small joints. Tofacitinib (TOF) is the first Janus Kinase Inhibitor (JAKi’s) approved by the European Medicines Agency and the Food and Drug Administration for the treatment of RA. This inhibits JAK1 and JAK3 involved in cytokine signaling proinflammatory in RA. Concepcion et al. ^[1] found that 16% of the patients on TOF presented adverse effects (AEs) and the most frequent of these was dyslipidemia, followed by elevated liver enzymes. Ytterberg et al found an increased risk of MACE with the use of tofacitinib recently ^[2].

Objectives To evaluate the risk of cardiovascular and adverse events with tofacitinib in rheumatoid arthritis.

Methods Retrospective, longitudinal, descriptive. Records from the database of the Rheumatology service of the Hospital Docente Padre Billini were reviewed between January 2016 and December 2021. Inclusion criteria: ≥18 years, diagnosis of RA according to the ACR/EULAR 2010 criteria, TOF 5mg every 12h ≥ 3 months. Exclusion criteria: patients with ≤ 3 months of treatment, history of cardiovascular event, liver disease, moderate anemia, severe neutropenia, history of herpes, absence of > 2 visits. A descriptive analysis of AEs and Major Adverse Cardiovascular Events (MACE) were performed using SPSSv23.

Results 215 met inclusion criteria. 87% (187) female. Mean age 57 + 11.5 years. Mean disease duration 7.6±2.3 years. HTA 49.8% (107), IMC>30 kg/m2 12.6% (27), DM 11.6% (25). Mean treatment with TOF 5±1.7 years. AEs and MACE 54%(101). AEs 73.3%(74): Hypercholesterolemia 26.7% (27), ALT or AST >3ULN 12.9% (13), herpes virus infection 8.9% (9), PMN: >500 8.9%(9), < 500: 7.9% (8), UTI 4.0% (4), severe anemia 4.0% (4). MACE 26.7%(27): mean age 60.2 + 9.1 years [Acute myocardial infarction (AMI) 63%(17), deep vein thrombosis 29.6%(8), cerebrovascular accident 7.4%(2)].

Conclusion In our review, AEs were found in half of the patients evaluated. Most of MACE events were associated with older age; the most frequent was AMI. Infections were found in a lower proportion. Little risk of infectious processes is demonstrated with the use of TOF. We must take precaution in those over 55 years of age and with cardiovascular risk comorbidities with the use of TOF consistent with that reported in the world literature.

References

1. L. Concepción-Sánchez et al. Experience with Tofacitinib: Epidemiological Aspects in the Dominican Republic. Rheumatology Service, Hospital Docente Padre Billini, Santo Domingo (2019).
2. Ytterberg, S. R., Bhatt, D. L., Mikuls, T. R., Koch, G. G., Fleischmann, R., Rivas, J. L., Germino, R., Menon, S., Sun, Y., Wang, C., Shapiro, A. B., Kanik, K. S., Connell, C. A., & ORAL Surveillance Investigators (2022). Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. The New England journal of medicine, 386(4), 316–326. https://doi.org/10.1056/NEJMoa2109927

Acknowledgements: NIL.

Disclosure of Interests None Declared.

Keywords: Targeted synthetic drugs, Rheumatoid arthritis, Cardiovascular disease

DOI: 10.1136/annrheumdis-2023-eular.4110