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Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment

Smolen J, Genovese M, Takeuchi T, Hyslop D, Macias W, Rooney T, Chen L, Dickson C, Riddle Camp J, Cardillo T, Ishii T and Winthrop K. - J Rheumatol. 2019 Jan;46(1):7-18. DOI: 10.3899/jrheum.171361

Baricitinib (BARI) showed an acceptable 5.5-year safety profile in this integrated analysis of patients with moderate-to-severe, active RA.
This study evaluated the safety profile of the oral, once daily Janus kinase inhibitor, BARI, in adults with moderately to severely active RA. Data from eight randomised clinical trials and one long-term extension study were pooled and analysed for placebo comparison and dose response.
There were 3492 patients who received BARI for a total of 6637 patient-years included in the study. No differences in rates of death, adverse events leading to drug discontinuation, malignancies, major adverse cardiovascular event, or serious infections were seen for BARI 4 mg versus placebo or BARI 2 mg. Cases of herpes zoster, deep vein thrombosis and pulmonary embolisms were reported with BARI 4 mg vs placebo.
Overall, in the context of demonstrated efficacy in patients with active RA, the data indicate that BARI 4 mg and BARI 2 mg once daily had an acceptable safety profile up to 5.5 years of exposure.

Keywords: JAK, Baricitinib, Clinical, Phase 3

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Upload date: October 2018

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