This article is more than 5 years old. Information may no longer be current.
Baricitinib not linked to adverse cardiovascular outcomes in RA
Baricitinib demonstrated no association with major adverse cardiovascular or venous thromboembolic events among patients with rheumatoid arthritis, according to a recent meta-analysis published in Arthritis & Rheumatology.
“In order to assess cardiovascular and venous thromboembolic events in clinical studies of baricitinib, an oral, selective JAK1/JAK2 inhibitor approved in selected countries for treatment of moderately-to-severely active RA, we examined data pooled from nine RA studies,” Peter C. Taylor, MA, PhD, from the Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, at the University of Oxford, England, told Healio Rheumatology. “Placebo comparison data was included in six studies up to 24 weeks.”
In an analysis of 3,492 patients with RA, the researchers assessed both 2-mg and 4-mg doses of baricitinib (Olumiant, Eli Lilly) along with associated long-term extension data.
“We found that for major adverse cardiovascular events, incidence rates were similar between the placebo and baricitinib 4-mg once daily groups and comparable between the baricitinib 2-mg once-daily and 4-mg once-daily dose groups,” Taylor said. “Furthermore, incidence rates did not increase with prolonged exposure.”
Similarly, neither arterial thrombotic events nor congestive heart failure were impacted by baricitinib treatment. Regarding venous thrombotic events such as deep vein thrombosis or pulmonary embolism, the researchers reported events in six of 997 patients treated with 4-mg baricitinib, compared with zero events in 1,070 patients treated with placebo. There were two serious events in this group, with risk factors present in all patients who experienced events.
“The number of events underlying this imbalance was small, and was not found to be reproduced during the first 24 weeks of treatment with baricitinib 4-mg among patients who transitioned to baricitinib from placebo or active comparator groups,” Taylor said.
Findings from a 2-mg and 4-mg-extended analysis set showed that incidence rates for deep vein thrombosis or pulmonary embolism were 0.5 per 100 patient-years in the 2-mg arm and 0.6 per 100 patient-years in the 4-mg arm. In a cohort of patients with RA treated only with baricitinib, the incidence rate of deep vein thrombosis or pulmonary embolism was 0.5 per 100 patient-years.
“During extended observation, incidence rates for venous thrombotic events were similar between the two baricitinib doses, consistent over time, and comparable to the expected rates for venous thrombotic events in RA based on the published literature,” Taylor said. “There was no observed association between platelet levels and venous thrombotic events.” – by Rob Volansky
Disclosure: Taylor reports receiving research and consulting support from Eli Lilly Company and Galapagos, and consulting support from AbbVie and Pfizer.