PMID- 26961485
OWN - NLM
STAT- MEDLINE
DCOM- 20170515
LR  - 20181113
IS  - 2005-6648 (Electronic)
IS  - 1226-3303 (Print)
IS  - 1226-3303 (Linking)
VI  - 31
IP  - 4
DP  - 2016 Jul
TI  - Efficacy and safety of low-dose tacrolimus for active rheumatoid arthritis with 
      an inadequate response to methotrexate.
PG  - 779-87
LID - 10.3904/kjim.2015.066 [doi]
AB  - BACKGROUND/AIMS: To determine the efficacy and safety of low-dose tacrolimus in 
      Korean rheumatoid arthritis (RA) subjects with an inadequate response to 
      methotrexate (MTX). METHODS: This was a multicenter, open-label study conducted 
      at five Korean sites. Fifty-six patients with active RA, despite treatment for >/= 
      1 month with a stable, maximally tolerated dosage of oral MTX (median dosage, 15 
      mg/wk), were enrolled and received 1.5 mg/day of tacrolimus as a single oral dose 
      once per day for 16 weeks while continuing to receive MTX. All other 
      disease-modifying anti-rheumatic drugs were discontinued, whereas stable dosages 
      of nonsteroidal anti-inflammatory drugs and oral corticosteroids (</= 10 mg/day of 
      prednisone or an equivalent corticosteroid) were allowed. The primary clinical 
      response criterion was the American College of Rheumatology's definition of 20% 
      improvement (ACR20) at the end of treatment. RESULTS: The ACR20 response rate was 
      42.9% (24 of 56 patients) in patients who had received tacrolimus at least once. 
      The overall ACR50 and ACR70 responses at the end of treatment for all patients 
      were 30.4% and 10.7%, respectively. Throughout the treatment period, 37 patients 
      experienced 71 adverse events (AEs) in total, and four patients left the study 
      because of AEs. In addition, 15 patients in total experienced treatment-related 
      AEs. Throughout the treatment period, two patients were reported to experience 
      two serious AEs, and one patient left the study because of a serious AE. 
      CONCLUSIONS: In patients whose active RA persists despite treatment with MTX, 
      low-dose tacrolimus in combination with MTX appears to be safe and well 
      tolerated, and provides clinical benefit.
FAU - Lee, Won-Seok
AU  - Lee WS
AD  - Division of Rheumatology, Department of Internal Medicine, Research Institute of 
      Clinical Medicine of Chonbuk National University-Biomedical Research Institute of 
      Chonbuk National University Hospital, Jeonju, Korea.
FAU - Lee, Sang-Il
AU  - Lee SI
AD  - Division of Rheumatology, Department of Internal Medicine, Gyeongsang National 
      University Hospital, Jinju, Korea.
FAU - Lee, Myeung-Soo
AU  - Lee MS
AD  - Division of Rheumatology, Department of Internal Medicine, Wonkwang University 
      Hospital, Iksan, Korea.
FAU - Kim, Sung-Il
AU  - Kim SI
AD  - Division of Rheumatology, Department of Internal Medicine, Pusan National 
      University Hospital, Busan, Korea.
FAU - Lee, Shin-Seok
AU  - Lee SS
AD  - Division of Rheumatology, Department of Internal Medicine, Chonnam National 
      University Hospital, Gwangju, Korea.
FAU - Yoo, Wan-Hee
AU  - Yoo WH
AD  - Division of Rheumatology, Department of Internal Medicine, Research Institute of 
      Clinical Medicine of Chonbuk National University-Biomedical Research Institute of 
      Chonbuk National University Hospital, Jeonju, Korea.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160310
PL  - Korea (South)
TA  - Korean J Intern Med
JT  - The Korean journal of internal medicine
JID - 8712418
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Calcineurin Inhibitors)
RN  - 0 (Immunosuppressive Agents)
RN  - WM0HAQ4WNM (Tacrolimus)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Antirheumatic Agents/*administration & dosage/adverse effects
MH  - Arthritis, Rheumatoid/diagnosis/*drug therapy
MH  - Calcineurin Inhibitors/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage/adverse effects
MH  - Male
MH  - Methotrexate/*administration & dosage/adverse effects
MH  - Middle Aged
MH  - Remission Induction
MH  - Republic of Korea
MH  - Tacrolimus/*administration & dosage/adverse effects
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC4939497
OTO - NOTNLM
OT  - Arthritis, rheumatoid
OT  - Methotrexate
OT  - Tacrolimus
COIS- No potential conflict of interest relevant to this article was reported.
EDAT- 2016/03/11 06:00
MHDA- 2017/05/16 06:00
PMCR- 2016/07/01
CRDT- 2016/03/11 06:00
PHST- 2015/03/10 00:00 [received]
PHST- 2015/06/08 00:00 [revised]
PHST- 2015/06/19 00:00 [accepted]
PHST- 2016/03/11 06:00 [entrez]
PHST- 2016/03/11 06:00 [pubmed]
PHST- 2017/05/16 06:00 [medline]
PHST- 2016/07/01 00:00 [pmc-release]
AID - kjim.2015.066 [pii]
AID - kjim-2015-066 [pii]
AID - 10.3904/kjim.2015.066 [doi]
PST - ppublish
SO  - Korean J Intern Med. 2016 Jul;31(4):779-87. doi: 10.3904/kjim.2015.066. Epub 2016 
      Mar 10.