Cardiovascular Safety During Treatment with Baricitinib in Rheumatoid Arthritis

Arthritis Rheumatol. 2019 Jul;71(7):1042-1055.

This study indicates no association between exposure to BARI and MACE, arterial thrombotic events (ATE), or congestive heart failure (CHF). Overall IRs for venous thromboembolic event (VTE) in BARI-treated patients falls within the reported range for patients with RA.RA patients have a greater risk of cardiovascular (CV) diseases of arterial ischemic origin, and an increased risk of VTE. Studied frequencies of thromboembolic events in RA populations in the last decade has been reported as 2–3x higher than in the healthy population. This study assesses CV and VTE from 9 pooled clinical studies of BARI, for treatment of RA.IRs were similar for BARI versus placebo for MACE, ATE, and CHF. Deep vein thrombosis (DVT)/pulmonary embolism (PE) were reported in 6/997 patients treated with BARI 4 mg and 0/1070 patients in the placebo group during the placebo-controlled period. IRs were comparable for BARI 2 and 4 mg in the extended analysis (DVT/PE, 2 mg and 4 mg = 0.5 & 0.6/100 patient years respectively). In the ‘All BARI-RA’ analysis set, rates were stable over time (with an IR of 0.5/100 patient years for DVT/PE).This integrated dataset indicates no association between exposure to BARI and MACE, ATE, or CHF. 6 VTE (DVT/PE) events were reported for BARI 4 mg but not placebo-treated patient. IRs during the longer-term evaluation were similar between doses, consistent over time, and comparable to published rates in RA.