Cardiovascular Safety During Treatment With Baricitinib in Rheumatoid Arthritis.

ABSTRACT:

Objective

To assess the frequency of cardiovascular and venous thromboembolic events in clinical studies of baricitinib, an oral, selective JAK1 and JAK2 inhibitor approved in more than 50 countries for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

Methods

Data were pooled from 9 RA studies. Placebo comparison up to 24 weeks included data from 6 studies. Randomized dose comparison between baricitinib doses of 2 mg and 4 mg used data from 4 studies and from the associated long-term extension study. The data analysis set designated "All-bari-RA" included all baricitinib exposures at any dose.

Results

Overall, 3,492 RA patients received baricitinib (7,860 patient-years of exposure). No imbalance compared to the placebo group was seen in the in

SUBMITTER: Taylor PC 

PROVIDER: S-EPMC6618316 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature