TBA (18A111)

Safety Profile of Baricitinib for the Treatment of Rheumatoid Arthritis up to 5.5 years: an Updated Integrated Safety Analysis


Mark C Genovese1, Josef S Smolen2, Tsutomu Takeuchi3, David Hyslop4, William L Macias4, Terence P Rooney4, Lei Chen4, Christina L Dickson4, Jennifer Riddle Camp4, Tracy E Cardillo4, Taeko Ishii5, Kevin L Winthrop6, Erica Tierney (Presenter only)7


1Stanford University Medical Center, Palo Alto, CA, USA; 2Medical University of Vienna, Vienna, Austria; 3Keio University, Tokyo, Japan; 4Eli Lilly and Company, Indianapolis, IN, USA; 5Eli Lilly and Company, Kobe, Japan; 6Oregon Health Sciences University, Portland, OR, USA; 7Presenting on behalf of the authors


Baricitinib (bari), an oral, selective inhibitor of Janus kinase (JAK) 1 and JAK 2, is approved in the EU, US, and Japan for the treatment of moderately to severely active RA in adults. We further describe the drug’s safety profile with updated data from an on-going long-term extension (LTE) study.


We further describe the drug’s safety profile with updated data from an on-going long-term extension (LTE) study.


Long-term safety of once-daily bari was evaluated in “all-bari-RA” dataset [all active RA patients on bari from 8 randomized trials (4 Ph3, 3 Ph2, 1 Ph1b) and 1 LTE study (data up to 01-Sept-2016)]. PBO comparisons were evaluated up to Wk 24 in “PBO-4mg” dataset from 6 Ph2/3 trials, in which patients were randomized to bari 4mg, censoring at rescue or treatment switch. Dose responses were evaluated from 4 Ph2/3 trials, in which patients were randomized to 2 or 4mg and includes data from LTE (“2mg-4mg-extended” dataset) censoring at rescue or dose change (as-treated analysis). Because of latent period for malignancy, 2mg 4mg extended was analyzed without censoring for rescue or dose change. Incidence rates (IR) per 100 patient years (PY) were calculated.


3492 patients received bari for 6637 total PY of exposure (>2400 PY increase from previous analysis); maximum exposure was 5.5 yrs. No differences were seen for bari 4mg vs PBO in AEs leading to permanent discontinuation, death, malignancy, serious infection, or MACE. Herpes zoster IR was significantly higher for bari 4mg vs PBO (IR 1.0 vs 4.3). Malignancy (excluding non-melanoma skin cancer) IR were 0.5 and 1.3 for 2mg and 4mg (as-treated analysis) and 0.7 and 0.9 (as-randomized analysis). IRs for aforementioned events and lymphoma (0.09), gastrointestinal perforation (0.05), and tuberculosis (0.15, all in endemic areas) in the current all-bari-RA were similar to previous reports. Less than 1% of patients discontinued due to abnormal lab results.


Baricitinib maintained a safety profile similar to previous reports1 and acceptable in the context of demonstrated efficacy.2,3

1. Smolen JS et al. Ann Rheum Dis 2016:75(Suppl 2):243-4.
2. Taylor PC et al. NEJM 2017:376:652-62.
3. Genovese Mc et al. NEJM 2016:374:1243-52.