PMID- 31729189
OWN - NLM
STAT- MEDLINE
DCOM- 20201119
LR  - 20211204
IS  - 1756-185X (Electronic)
IS  - 1756-1841 (Linking)
VI  - 23
IP  - 1
DP  - 2020 Jan
TI  - Safety of baricitinib in East Asian patients with moderate-to-severe active 
      rheumatoid arthritis: An integrated analysis from clinical trials.
PG  - 65-73
LID - 10.1111/1756-185X.13748 [doi]
AB  - AIM: We evaluated the safety of baricitinib in an East Asian (EA) patient 
      population with moderate-to-severely active rheumatoid arthritis (RA), through an 
      integrated sub-analysis of data from the overall baricitinib RA clinical program. 
      METHODS: Data from EA patients who received any dose of baricitinib from five 
      completed studies (1 Phase 2, 4 Phase 3) and an ongoing long-term extension study 
      were pooled up to 1 September, 2016. Exposure-adjusted incidence rates (EAIR) and 
      incidence rates (IRs), both per 100 patient-years (PY), were calculated. RESULTS: 
      This analysis included 740 EA patients with 1294 PY of total baricitinib exposure 
      (maximum 3.5 years). Overall, 109 patients discontinued baricitinib due to 
      adverse events (AEs); EAIR: 8.4. No deaths were reported in this cohort. Serious 
      AEs were reported by 125 patients (EAIR: 9.7). Serious infections were the most 
      common serious AEs (n = 53, IR: 4.15). IR of herpes zoster infection was 6.2; the 
      majority of events were of mild-to-moderate severity. Three cases (IR: 0.23) of 
      tuberculosis were reported. The IRs of malignancy (excluding non-melanoma skin 
      cancer) was 0.99 and EAIR specifically of lymphoma was 0.1. The IR of major 
      adverse cardiovascular events was 0.26, and deep vein thrombosis was reported in 
      four patients (EAIR: 0.3). Two cases of gastrointestinal perforations (EAIR: 0.2) 
      were reported. CONCLUSION: Integrated data show that baricitinib is 
      well-tolerated in EA patients with moderate-to-severely active RA in the context 
      of demonstrated efficacy, which is generally consistent with safety results of 
      the overall study population.
CI  - (c) 2019 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons 
      Australia, Ltd.
FAU - Chen, Ying-Chou
AU  - Chen YC
AUID- ORCID: 0000-0002-9404-2900
AD  - Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of 
      Medicine, Kaohsiung, Taiwan.
FAU - Yoo, Dae Hyun
AU  - Yoo DH
AD  - Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea.
FAU - Lee, Chang Keun
AU  - Lee CK
AD  - Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.
FAU - Li, Ko-Jen
AU  - Li KJ
AD  - National Taiwan University Hospital, Taipei, Taiwan.
FAU - Won, Ji-Eon
AU  - Won JE
AD  - Eli Lilly Korea, Seoul, Korea.
FAU - Wu, Wen-Shuo
AU  - Wu WS
AUID- ORCID: 0000-0002-6259-3409
AD  - Eli Lilly and Company (Taiwan) Inc., Taipei, Taiwan.
FAU - Zhong, Jinglin
AU  - Zhong J
AD  - IQVIA, Inc., Durham, NC, USA.
FAU - Nicolay, Claudia
AU  - Nicolay C
AD  - Lilly Deutschland GmbH, Bad Homburg, Germany.
FAU - Walls, Chad Daniel
AU  - Walls CD
AD  - Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AD  - The First Department of Internal Medicine, School of Medicine, University of 
      Occupational and Environmental Health, Japan, Kitakyushu, Japan.
LA  - eng
GR  - Incyte Corporation/
GR  - Eli Lilly and Company/
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20191114
PL  - England
TA  - Int J Rheum Dis
JT  - International journal of rheumatic diseases
JID - 101474930
RN  - 0 (Azetidines)
RN  - 0 (Purines)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - ISP4442I3Y (baricitinib)
SB  - IM
MH  - Arthritis, Rheumatoid/*drug therapy/epidemiology
MH  - Azetidines/*administration & dosage
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Purines
MH  - Pyrazoles
MH  - Republic of Korea/epidemiology
MH  - Sulfonamides/*administration & dosage
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - East Asia
OT  - Janus kinase (JAK)
OT  - baricitinib
OT  - clinical studies
OT  - rheumatoid arthritis
OT  - safety
EDAT- 2019/11/16 06:00
MHDA- 2020/11/20 06:00
CRDT- 2019/11/16 06:00
PHST- 2019/07/09 00:00 [received]
PHST- 2019/10/10 00:00 [revised]
PHST- 2019/10/23 00:00 [accepted]
PHST- 2019/11/16 06:00 [pubmed]
PHST- 2020/11/20 06:00 [medline]
PHST- 2019/11/16 06:00 [entrez]
AID - 10.1111/1756-185X.13748 [doi]
PST - ppublish
SO  - Int J Rheum Dis. 2020 Jan;23(1):65-73. doi: 10.1111/1756-185X.13748. Epub 2019 
      Nov 14.