PMID- 24261753
OWN - NLM
STAT- MEDLINE
DCOM- 20140731
LR  - 20221207
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 24
IP  - 1
DP  - 2014 Jan
TI  - Post-marketing surveillance of the safety and effectiveness of tacrolimus in 
      3,267 Japanese patients with rheumatoid arthritis.
PG  - 8-16
LID - 10.3109/14397595.2013.854074 [doi]
AB  - OBJECTIVES: A post-marketing surveillance (PMS) program was implemented to assess 
      the safety and effectiveness of tacrolimus (TAC) in Japanese rheumatoid arthritis 
      (RA) patients and to identify risk factors related to adverse drug reactions 
      (ADRs). METHODS: Patients were registered centrally and monitored for all adverse 
      events (AEs) for 24 weeks. Effectiveness was evaluated using the Disease Activity 
      Score 28-CRP (DAS28-CRP). RESULTS: Data from 3,172 patients (mean age 62.2 years) 
      were evaluated in the safety analysis. Of the safety population, 78.5 %were 
      female and 25.9 % were in Steinbrocker's functional class 3 or 4. TAC was 
      prescribed as monotherapy in 52.5 % and the most common concomitant disease 
      modifying antirheumatic drug (DMARD) was methotrexate, used in 28.9 % of the 
      patients. The incidence of AEs, serious AEs (SAEs), ADRs and serious ADRs were 
      41.2, 6.4, 36.0, and 4.9 %, respectively. The most frequent serious ADR category 
      was infections and infestations. Age >/= 65 years, concurrent renal dysfunction, 
      and concurrent diabetes mellitus were identified as significant risk factors for 
      ADR. Based on EULAR response criteria, 65.4 % of the patients showed moderate or 
      good response. CONCLUSIONS: The results demonstrate that TAC is well tolerated by 
      Japanese patients with active RA, including those receiving concomitant 
      methotrexate, in the real world.
FAU - Takeuchi, Tsutomu
AU  - Takeuchi T
AD  - Division of Rheumatology, Department of Internal Medicine, Keio University School 
      of Medicine , 35 Shinanomachi, Shinjyuku-ku, Tokyo 160-8582 , Japan.
FAU - Kawai, Shinichi
AU  - Kawai S
FAU - Yamamoto, Kazuhiko
AU  - Yamamoto K
FAU - Harigai, Masayoshi
AU  - Harigai M
FAU - Ishida, Kota
AU  - Ishida K
FAU - Miyasaka, Nobuyuki
AU  - Miyasaka N
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - WM0HAQ4WNM (Tacrolimus)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*adverse effects/therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Asian People
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Middle Aged
MH  - *Product Surveillance, Postmarketing
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Tacrolimus/*adverse effects/therapeutic use
MH  - Treatment Outcome
EDAT- 2013/11/23 06:00
MHDA- 2014/08/01 06:00
CRDT- 2013/11/23 06:00
PHST- 2013/11/23 06:00 [entrez]
PHST- 2013/11/23 06:00 [pubmed]
PHST- 2014/08/01 06:00 [medline]
AID - 10.3109/14397595.2013.854074 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2014 Jan;24(1):8-16. doi: 10.3109/14397595.2013.854074.