Rheumatoid arthritis

Risk of Venous Thromboembolism With Tofacitinib Versus Tumor Necrosis Factor Inhibitors in Cardiovascular Risk‐Enriched Rheumatoid Arthritis Patients

Arthritis RheumatolPublished Post hoc analysis of the ORAL Surveillance randomised trial

Authors' conclusion

Incidences of VTE and PE were higher with tofacitinib (10 > 5 mg BID) versus TNFi and were generally consistent over time.

Study context

Population
Patients with rheumatoid arthritis (RA) aged 50 years or older with at least one additional cardiovascular risk factor
Comparison
Tofacitinib 5 or 10 mg BID vs TNFi
Primary endpoint
Cumulative probabilities and incidence rates (patients with first events/100 patient-years) by 6-month intervals of adjudicated VTE, DVT and pulmonary embolism (PE)
Methodological detailsCox regression
  • Cox regression

Primary result

As reported in the abstract

Cumulative probabilities for VTE and PE
  • Higher with tofacitinib 10 mg BID, but not 5 mg BID, vs TNFi
  • Incidence rates consistent across 6-month intervals within treatments
  • Post hoc

Further findings

Risk factors for venous thromboembolism (VTE) across treatments

Prior VTE, BMI ≥35 kg/m², older age and history of chronic lung disease

Disease activity (CDAI) at time of VTE

Most patients with VTE had active disease by CDAI

Original publication

Risk of Venous Thromboembolism With Tofacitinib Versus Tumor Necrosis Factor Inhibitors in Cardiovascular Risk‐Enriched Rheumatoid Arthritis Patients. Arthritis Rheumatol. Published 19 April 2024. doi:10.1002/art.42846

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