Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 7 Years: An Updated Integrated Safety Analysis


Mark C Genovese1, Josef S Smolen2, Tsutomu Takeuchi3, Gerd Burmester4, Dennis Brinker5, Terence P Rooney5, Jinglin Zhong6, Daojun Mo5, Chadi Saifan5, Anabela Cardoso5, Maher Issa5, Wen-Shuo Wu5, Kevin L Winthrop7


1 Division of Immunology and Rheumatology, Stanford University, Palo Alto, CA, USA 2 Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria 3 Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan 4 Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany 5 Eli Lilly and Company, Indianapolis, IN, USA 6 IQVIA, Morrisville, NC, USA 7 Oregon Health Sciences University, Portland, OR, USA


Baricitinib (BARI), an oral, selective inhibitor of Janus kinase (JAK)1/2, is used to treat moderate to severe rheumatoid arthritis (RA) in adults.


We describe the drug’s safety profile with updated data from an additional Phase (Ph) 3 trial and an on-going long-term extension (LTE) study.


Long-term safety of once-daily BARI was evaluated in the All-BARI-RA dataset: all patients (pts) exposed to BARI from 9 randomized trials (5 Ph3, 3 Ph2, 1 Ph 1b) and 1 LTE (data to February 13, 2018). Placebo (PBO) comparisons were evaluated to Week 24 from 7 Ph2/3 trials: pts randomized to PBO, BARI 2-mg or 4-mg, with censoring at rescue/treatment switch. Dose responses were evaluated in the 2-mg/4-mg extended dataset from 4 Ph2/3 trials: pts randomized to 2-mg or 4-mg, LTE data included; data censored at rescue/dose change (as-treated analysis) and analyzed without censoring (as-randomized analysis). Incidence rates (IRs) per 100 patient-years (PY) were calculated.


Totally, 3770 pts received BARI (10,127 PYs); maximum exposure was 7 years. No significant differences were seen for BARI 4-mg vs PBO in adverse events leading to permanent drug discontinuation, death, malignancy, serious infection, or major adverse cardiovascular events. Herpes zoster IR was significantly higher for BARI 4-mg than PBO (3.8 vs 0.9) and numerically higher for BARI 2-mg (3.1). The IRs for deep vein thrombosis/pulmonary embolism were numerically higher in BARI 4-mg than PBO; IRs were similar by dose in 2-mg/4-mg extended dataset. Malignancy (excluding non-melanoma skin cancer) IRs were 0.8 (2 mg) and 1.0 (4 mg; as-randomized analysis). Fewer than 1% pts discontinued for abnormal laboratory results.


BARI maintained a safety profile similar to that previously reported and acceptable in the context of demonstrated efficacy.

Previously presented at EULAR (2019).