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Cardiovascular Safety During Treatment With Baricitinib in Rheumatoid Arthritis

Authors :
Tsutomu Takeuchi
Anabela Cardoso
Maher Issa
Michael E. Weinblatt
C. Walls
Gerd R Burmester
Peter C. Taylor
Sarah Witt
Chadi Saifan
Xin Zhang
Terence Rooney
Miguel A. González-Gay
Claudia A. Salinas
Universidad de Cantabria
Source :
Arthritis & Rheumatology (Hoboken, N.j.), Arthritis Rheumatol. 2019 Jul;71(7):1042-1055, UCrea Repositorio Abierto de la Universidad de Cantabria, Universidad de Cantabria (UC)
Publication Year :
2019
Publisher :
Wiley, 2019.

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 incidence of major adverse cardiovascular events (MACE) (incidence rates [IRs] of 0.5 per 100 patient‐years for placebo and 0.8 per 100 patient‐years for 4 mg baricitinib), arterial thrombotic events (ATE) (IRs of 0.5 per 100 patient‐years for placebo and 0.5 per 100 patient‐years for 4 mg baricitinib), or congestive heart failure (CHF) broad term (IRs of 4.3 per 100 patient‐years for placebo and 2.4 per 100 patient‐years for 4 mg baricitinib). Deep vein thrombosis (DVT)/pulmonary embolism (PE) were reported in 0 of 1,070 patients treated with placebo and 6 of 997 patients treated with 4 mg baricitinib during the placebo‐controlled period; these events were serious in 2 of 6 patients, while all 6 had risk factors and 1 patient developed DVT/PE after discontinuation of the study drug. In the 2 mg–4 mg‐extended data analysis set, IRs of DVT/PE were comparable between the doses across event types (IRs of 0.5 per 100 patient‐years in those receiving 2 mg baricitinib and 0.6 per 100 patient‐years in those receiving 4 mg baricitinib). In the All‐bari‐RA data analysis set, the rates were stable over time, with an IR of DVT/PE of 0.5 per 100 patient‐years. Conclusions In RA clinical trials, no association was found between baricitinib treatment and the incidence of MACE, ATE, or CHF. With regard to incidence of DVT/PE, 6 events occurred in patients treated with 4 mg baricitinib, but no cases of DVT/PE were reported in the placebo group. During longer‐term evaluation, the incidence of DVT/PE was similar between the baricitinib dose groups, with consistent IR values over time, and this was similar to the rates previously reported in patients with RA.

Details

ISSN :
23265205 and 23265191
Volume :
71
Database :
OpenAIRE
Journal :
Arthritis & Rheumatology
Accession number :
edsair.doi.dedup.....cd284d7be0cc129a2604b708afc4dd1c
Full Text :
https://doi.org/10.1002/art.40841