PMID- 37476363
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230722
IS  - 2233-4718 (Electronic)
IS  - 2093-940X (Print)
IS  - 2233-4718 (Linking)
VI  - 28
IP  - 4
DP  - 2021 Oct 1
TI  - Safety of Tacrolimus in Autoimmune Disease: Results From Post-marketing 
      Surveillance in South Korea.
PG  - 202-215
LID - 10.4078/jrd.2021.28.4.202 [doi]
AB  - OBJECTIVE: Tacrolimus, a macrolide immunosuppressant, is approved in Korea for 
      the treatment of rheumatoid arthritis (RA), lupus nephritis (LN) and myasthenia 
      gravis (MG) We report three prospective post-marketing surveillance studies of 
      tacrolimus conducted in South Korea in these indications. METHODS: Studies were 
      conducted according to South Korean Ministry of Food and Drug Safety requirements 
      Patients were followed up for the duration of the study (up to 4 years) or until 
      treatment discontinuation Occurrence and likely relationship with tacrolimus of 
      adverse events (AEs), adverse drug reactions (ADRs; defined as AEs where causal 
      relationship to tacrolimus could not be excluded) and serious AEs were recorded 
      Association of AEs with demographic and medical factors was evaluated by 
      multivariable analysis. RESULTS: The studies included 740 (RA), 307 (LN) and 104 
      (MG) patients The incidence of AEs was 127% in RA (642% of AEs potentially 
      related to tacrolimus), 209% (378% potentially related) in LN and 298% (568% 
      potentially related) in MG The incidence of ADRs was 84%, 98% and 202%, 
      respectively Serious AEs were reported in 07%, 72% and 87%, respectively The most 
      common AEs were abdominal pain (RA), pharyngitis (LN) and diarrhea (MG) 
      Unexpected AEs occurred in 35% of patients with RA, 29% in LN and 87% in MG; no 
      pattern of unexpected AEs was apparent Multivariable analysis demonstrated that 
      patients with comorbidity had higher probability of experiencing an AE in RA and 
      MG studies. CONCLUSION: The incidence of AEs and the safety profile of tacrolimus 
      in each indication was consistent with previous reports.
CI  - Copyright (c) 2021 by The Korean College of Rheumatology. All rights reserved.
FAU - Yoo, Wan-Hee
AU  - Yoo WH
AD  - Division of Rheumatology, Department of Internal Medicine, Jeonbuk National 
      University Medical School, Jeonju, Korea.
FAU - Lee, Sang-Il
AU  - Lee SI
AD  - Department of Internal Medicine, Institute of Health Sciences, Gyeongsang 
      National University School of Medicine, Jinju, Korea.
FAU - Kim, Tae-Hwan
AU  - Kim TH
AD  - Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 
      Seoul, Korea.
FAU - Sung, Jung-Joon
AU  - Sung JJ
AD  - Department of Neurology, Seoul National University College of Medicine, Seoul 
      National University Hospital, Seoul, Korea.
FAU - Kim, Seung Min
AU  - Kim SM
AD  - Department of Neurology, Yonsei University College of Medicine, Seoul, Korea.
FAU - Hua, Fan
AU  - Hua F
AD  - Astellas Pharma Singapore Pte Ltd., Singapore, Korea.
FAU - Sumarsono, Budiwan
AU  - Sumarsono B
AD  - Astellas Pharma Singapore Pte Ltd., Singapore, Korea.
FAU - Park, Sung Hwan
AU  - Park SH
AUID- ORCID: 0000-0003-1711-2060
AD  - Division of Rheumatology, Department of Internal Medicine, Seoul St. Mary's 
      Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - Korea (South)
TA  - J Rheum Dis
JT  - Journal of rheumatic diseases
JID - 101571816
PMC - PMC10324909
OTO - NOTNLM
OT  - Autoimmune disease
OT  - Post-marketing product surveillance
OT  - Safety
OT  - Tacrolimus
COIS- CONFLICT OF INTEREST All authors report non-financial support from Astellas 
      Pharma, Inc., during the conduct of the study. FH and BS are employees of 
      Astellas Pharma Singapore Pte Ltd., Singapore.
EDAT- 2021/10/01 00:00
MHDA- 2021/10/01 00:01
PMCR- 2021/10/01
CRDT- 2023/07/21 04:04
PHST- 2020/12/28 00:00 [received]
PHST- 2021/07/05 00:00 [revised]
PHST- 2021/07/09 00:00 [accepted]
PHST- 2021/10/01 00:01 [medline]
PHST- 2021/10/01 00:00 [pubmed]
PHST- 2023/07/21 04:04 [entrez]
PHST- 2021/10/01 00:00 [pmc-release]
AID - jrd-28-4-202 [pii]
AID - 10.4078/jrd.2021.28.4.202 [doi]
PST - ppublish
SO  - J Rheum Dis. 2021 Oct 1;28(4):202-215. doi: 10.4078/jrd.2021.28.4.202.