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Cardiovascular Safety During Treatment with Baricitinib in Rheumatoid Arthritis

Author

Taylor PC1, Weinblatt ME2, Burmester GR3, Rooney TP4, Witt S4, Walls CD4, Issa M4, Salinas CA4, Saifan C4, Zhang X4, Cardoso A4, González-Gay MA5,6,7, Takeuchi T8. Arthritis Rheumatol. 2019 Jan 21. doi: 10.1002/art.40841. [Epub ahead of print]

Author Information

1 Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

2 Brigham and Women's Hospital, Boston, MA, USA.

3 Charité Universitätsmedizin Berlin, Berlin, Germany.

4 Eli Lilly and Company, Indianapolis, USA.

5 Epidemiology, Genetics and Atherosclerosis Research Group on Systemic Inflammatory Diseases, Rheumatology Division, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.

6 Department of Medicine, University of Cantabria, Santander, Spain.

7 Cardiovascular Pathophysiology and Genomics Research Unit, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

8 Keio University School of Medicine, Tokyo, Japan

Abstract

OBJECTIVE: 

To assess cardiovascular and venous thromboembolic events in clinical studies of baricitinib, an oral, selective Janus kinase (JAK)1/JAK2 inhibitor approved in selected countries for treatment of moderately-to-severely active rheumatoid arthritis (RA).

 

METHODS: 

Data were pooled from 9 RA studies. Placebo comparison included 6 studies up to 24 weeks. Randomized dose comparison used 4 studies including baricitinib 2-mg and 4-mg, and associated long-term extension (LTE) data. The 'All-bari-RA' set included all baricitinib exposures at any dose.

 

RESULTS: 

Overall, 3492 patients received baricitinib (7860 patient-years of exposure [PYE]). No imbalance was seen versus placebo for major adverse cardiovascular events (MACE), arterial thrombotic events (ATE), or congestive heart failure (CHF). Deep vein thrombosis (DVT)/pulmonary embolism (PE) were reported in 0/1070 patients treated with placebo and 6/997 with baricitinib 4-mg during the placebo-controlled period; 2 were serious, all had risk factors, and 1 occurred after discontinuing study drug. In the 2mg-4mg-extended analysis set, incidence rates (IRs) were comparable between doses across event types; for DVT/PE, 2-mg = 0.5, 4-mg = 0.6 per 100 patient years (PY). In the All-bari-RA analysis set, rates were stable over time, with an IR of 0.5 per 100 PY for DVT/PE.

 

CONCLUSIONS: 

In RA clinical trials, no association was found between baricitinib treatment and MACE, ATE, or CHF. For DVT/PE, 6 events were reported for baricitinib 4-mg but not placebo; during longer-term evaluation, IRs were similar between doses, consistent over time, and similar to published rates in RA.