PMID- 30619999
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2471-254X (Electronic)
IS  - 2471-254X (Linking)
VI  - 3
IP  - 1
DP  - 2019 Jan
TI  - Chloroquine Is Effective for Maintenance of Remission in Autoimmune Hepatitis: 
      Controlled, Double-Blind, Randomized Trial.
PG  - 116-128
LID - 10.1002/hep4.1275 [doi]
AB  - Between 50% and 86% of patients with autoimmune hepatitis (AIH) relapse after 
      immunosuppression withdrawal; long-term immunosuppression is associated with 
      increased risk of neoplasias and infections. Chloroquine diphosphate (CQ) is an 
      immunomodulatory drug that reduces the risk of flares in rheumatologic diseases. 
      Our aims were to investigate the efficacy and safety of CQ for maintenance of 
      biochemical remission of AIH in a double-blind randomized trial and to define a 
      subgroup that obtained a greater benefit from its use. A total of 61 patients 
      with AIH in histologic remission (90.1% AIH type 1 [AIH-1]) were randomized to 
      receive CQ 250 mg/day or placebo for 36 months. Of the 61 patients, 31 received 
      CQ and 30 placebo. At baseline, clinical, laboratory, histologic findings, and 
      human leukocyte antigen (HLA) profile were similar between the two groups. 
      Relapse-free survival was significantly higher in the CQ group compared to the 
      placebo group (59.3% and 19.9%, respectively P = 0.039). For those patients 
      completing 3-year treatment, relapse rates were 41.6% and 0% after CQ and placebo 
      withdrawal, respectively. Factors associated with a higher risk of relapse in 
      multiple Cox regression were placebo use (hazard ratio, 2.4; 95% confidence 
      interval [CI], 1.055.5; P = 0.039) and anti-soluble liver antigen/liver-pancreas 
      (anti-SLA/LP) seropositivity (hazard ratio, 5.4; 95% CI, 1.91-15.3; P = 0.002). 
      Although it was not possible to define a subgroup that obtained a greater benefit 
      from CQ according to anti-SLA/LP reactivity or HLA profile, 100% of patients who 
      were anti-SLA/LP-positive (+) relapsed with placebo compared to 50% with CQ (P = 
      0.055). In the CQ group, 54.8% had side effects and 19.3% interrupted the drug 
      regimen. Conclusion: CQ safely reduced the risk of relapse of AIH, but it was not 
      possible to define a subgroup that obtained a greater benefit with CQ use, 
      probably because of sample size.
FAU - Raquel Benedita Terrabuio, Debora
AU  - Raquel Benedita Terrabuio D
AD  - Department of Gastroenterology, Division of Clinical Gastroenterology and 
      Hepatology, Hospital das Clinicas University of Sao Paulo School of Medicine Sao 
      Paulo Brazil.
FAU - Augusto Diniz, Marcio
AU  - Augusto Diniz M
AD  - Biostatistics and Bioinformatics Research Center Samuel Oschin Comprehensive 
      Cancer Institute, Cedars-Sinai Medical Center Los Angeles CA.
FAU - Teofilo de Moraes Falcao, Lydia
AU  - Teofilo de Moraes Falcao L
AD  - Department of Gastroenterology, Division of Clinical Gastroenterology and 
      Hepatology, Hospital das Clinicas University of Sao Paulo School of Medicine Sao 
      Paulo Brazil.
FAU - Luiza Vilar Guedes, Ana
AU  - Luiza Vilar Guedes A
AD  - Department of Gastroenterology, Division of Clinical Gastroenterology and 
      Hepatology, Hospital das Clinicas University of Sao Paulo School of Medicine Sao 
      Paulo Brazil.
FAU - Akeme Nakano, Larissa
AU  - Akeme Nakano L
AD  - Department of Gastroenterology, Division of Clinical Gastroenterology and 
      Hepatology, Hospital das Clinicas University of Sao Paulo School of Medicine Sao 
      Paulo Brazil.
FAU - Silva Evangelista, Andreia
AU  - Silva Evangelista A
AD  - Department of Gastroenterology, Division of Clinical Gastroenterology and 
      Hepatology, Hospital das Clinicas University of Sao Paulo School of Medicine Sao 
      Paulo Brazil.
FAU - Roberto Lima, Fabiana
AU  - Roberto Lima F
AD  - Department of Pathology University of Sao Paulo School of Medicine Sao Paulo 
      Brazil.
FAU - Pires Abrantes-Lemos, Clarice
AU  - Pires Abrantes-Lemos C
AD  - Laboratory of Medical Investigation of Immunopathology of Schistosomiasis 
      Institute of Tropical Medicine of University of Sao Paulo Sao Paulo Brazil.
FAU - Jose Carrilho, Flair
AU  - Jose Carrilho F
AD  - Department of Gastroenterology, Division of Clinical Gastroenterology and 
      Hepatology, Hospital das Clinicas University of Sao Paulo School of Medicine Sao 
      Paulo Brazil.
FAU - Luiz Rachid Cancado, Eduardo
AU  - Luiz Rachid Cancado E
AD  - Department of Gastroenterology, Division of Clinical Gastroenterology and 
      Hepatology, Hospital das Clinicas University of Sao Paulo School of Medicine Sao 
      Paulo Brazil.
AD  - Laboratory of Medical Investigation of Immunopathology of Schistosomiasis 
      Institute of Tropical Medicine of University of Sao Paulo Sao Paulo Brazil.
LA  - eng
PT  - Journal Article
DEP - 20181114
PL  - United States
TA  - Hepatol Commun
JT  - Hepatology communications
JID - 101695860
PMC - PMC6312658
EDAT- 2019/01/09 06:00
MHDA- 2019/01/09 06:01
PMCR- 2018/11/14
CRDT- 2019/01/09 06:00
PHST- 2018/06/18 00:00 [received]
PHST- 2018/10/12 00:00 [accepted]
PHST- 2019/01/09 06:00 [entrez]
PHST- 2019/01/09 06:00 [pubmed]
PHST- 2019/01/09 06:01 [medline]
PHST- 2018/11/14 00:00 [pmc-release]
AID - HEP41275 [pii]
AID - 10.1002/hep4.1275 [doi]
PST - epublish
SO  - Hepatol Commun. 2018 Nov 14;3(1):116-128. doi: 10.1002/hep4.1275. eCollection 
      2019 Jan.