PMID- 30784354
OWN - NLM
STAT- MEDLINE
DCOM- 20200406
LR  - 20211204
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 30
IP  - 1
DP  - 2020 Jan
TI  - 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.
PG  - 36-43
LID - 10.1080/14397595.2019.1583711 [doi]
AB  - 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 gastrointestinal 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.Trial registration: NCT01185353, 
      NCT00902486, NCT01469013, NCT01710358, NCT01721044, NCT01721057, NCT01711359, and 
      NCT01885078 at https://clinicaltrials.gov/.
FAU - Harigai, Masayoshi
AU  - Harigai M
AD  - Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, 
      Department of Rheumatology, School of Medicine, Tokyo Women's Medical University, 
      Tokyo, Japan.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - Division of Rheumatology, Department of Internal Medicine, Keio University School 
      of Medicine, Tokyo, Japan.
FAU - Smolen, Josef S
AU  - Smolen JS
AD  - Division of Rheumatology, Department of Medicine, Medical University of Vienna, 
      Vienna, Austria.
FAU - Winthrop, Kevin L
AU  - Winthrop KL
AD  - Department of Medicine & Ophthalmology, Oregon Health & Science University, 
      Portland, OR, USA.
FAU - Nishikawa, Atsushi
AU  - Nishikawa A
AD  - Medicines Development Unit, Eli Lilly Japan K.K., Kobe, Japan.
FAU - Rooney, Terence P
AU  - Rooney TP
AD  - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Saifan, Chadi G
AU  - Saifan CG
AD  - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Issa, Maher
AU  - Issa M
AD  - Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
FAU - Isaka, Yoshitaka
AU  - Isaka Y
AD  - Medicines Development Unit, Eli Lilly Japan K.K., Kobe, Japan.
FAU - Akashi, Naotsugu
AU  - Akashi N
AD  - Medicines Development Unit, Eli Lilly Japan K.K., Kobe, Japan.
FAU - Ishii, Taeko
AU  - Ishii T
AD  - Medicines Development Unit, Eli Lilly Japan K.K., Kobe, Japan.
FAU - Tanaka, Yoshiya
AU  - Tanaka Y
AD  - First Department of Internal Medicine, School of Medicine, University of 
      Occupational and Environmental Health, Kitakyushu, Japan.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20190321
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Azetidines)
RN  - 0 (Purines)
RN  - 0 (Pyrazoles)
RN  - 0 (Sulfonamides)
RN  - EC 2.7.10.2 (JAK1 protein, human)
RN  - EC 2.7.10.2 (JAK2 protein, human)
RN  - EC 2.7.10.2 (Janus Kinase 1)
RN  - EC 2.7.10.2 (Janus Kinase 2)
RN  - ISP4442I3Y (baricitinib)
SB  - IM
MH  - Administration, Oral
MH  - Arthritis, Rheumatoid/*drug therapy/metabolism
MH  - Azetidines/*administration & dosage/adverse effects
MH  - Dose-Response Relationship, Drug
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Janus Kinase 1/antagonists & inhibitors
MH  - Janus Kinase 2/antagonists & inhibitors
MH  - Japan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Purines
MH  - Pyrazoles
MH  - Sulfonamides/*administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Baricitinib
OT  - Janus kinase (JAK)
OT  - Japanese
OT  - rheumatoid arthritis
OT  - safety
EDAT- 2019/02/21 06:00
MHDA- 2020/04/09 06:00
CRDT- 2019/02/21 06:00
PHST- 2019/02/21 06:00 [pubmed]
PHST- 2020/04/09 06:00 [medline]
PHST- 2019/02/21 06:00 [entrez]
AID - 10.1080/14397595.2019.1583711 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2020 Jan;30(1):36-43. doi: 10.1080/14397595.2019.1583711. Epub 
      2019 Mar 21.