We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Safety profile of baricitinib in Japanese patients with active rheumatoid arthritis with over 1.6 years median time in treatment: An integrated analysis of Phases 2 and 3 trials.
- Authors
Masayoshi Harigai; Tsutomu Takeuchi; Smolen, Josef S.; Winthrop, Kevin L.; Atsushi Nishikawa; Rooney, Terence P.; Saifan, Chadi G.; Maher Issa; Yoshitaka Isaka; Naotsugu Akashi; Taeko Ishii; Yoshiya Tanaka
- Abstract
Objectives: Baricitinib is a selective oral inhibitor of JAK1/JAK2 for patients with moderately-to-severely active rheumatoid arthritis (RA). Baricitinib's safety profile in Japanese patients was evaluated using six studies (five Ph2/Ph3 trials, one long-term extension study through 01 September 2016) from an integrated database (nine RA studies). Methods: Incidence rates (IRs) or exposure-adjusted IRs (EAIRs) of adverse events (AEs) per 100 patient-years (PY) were calculated using data which included RA patients exposed to any baricitinib dose. Results: Five hundred and fourteen Japanese patients received baricitinib for 851.5 total PY of exposure (median 1.7 years, maximum 3.2). The EAIR of treatment-emergent AEs was 57.4/100PY. There were no deaths; 31 patients had serious infections (IR: 3.6/100PY), 55 herpes zoster (6.5), 0 tuberculosis, 10 malignancies (1.1) including two lymphomas, two major cardiovascular AEs (0.3), one gastro- intestinal perforation (0.1), and four deep vein thrombosis (0.5). In Japanese patients, herpes zoster was more frequent than that of patients overall in the integrated database, but the events were considered manageable. Conclusion: In this analysis, baricitinib had acceptable safety profile in Japanese RA patients in the context of demonstrated efficacy. Aside from herpes zoster, baricitinib safety was not notably different between Japanese RA patients and those RA patients in the integrated database.
- Subjects
RHEUMATOID arthritis; ADVERSE health care events; JANUS kinases; LYMPHOMAS; CARDIOVASCULAR agents
- Publication
Modern Rheumatology, 2020, Vol 30, Issue 1, p36
- ISSN
1439-7595
- Publication type
Article
- DOI
10.1080/14397595.2019.1583711