{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T09:22:46Z","timestamp":1773393766755,"version":"3.50.1"},"reference-count":34,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2018,11,14]],"date-time":"2018-11-14T00:00:00Z","timestamp":1542153600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Hepatol Commun"],"published-print":{"date-parts":[[2019,1]]},"abstract":"<jats:p>Between 50% and 86% of patients with autoimmune hepatitis (AIH) relapse after immunosuppression withdrawal; long\u2010term 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\u2010blind 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\u20101]) 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\u2010free survival was significantly higher in the CQ group compared to the placebo group (59.3% and 19.9%, respectively <jats:italic toggle=\"yes\">P<\/jats:italic> = 0.039). For those patients completing 3\u2010year 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; <jats:italic toggle=\"yes\">P<\/jats:italic> = 0.039) and anti\u2010soluble liver antigen\/liver\u2010pancreas (anti\u2010SLA\/LP) seropositivity (hazard ratio, 5.4; 95% CI, 1.91\u201015.3; <jats:italic toggle=\"yes\">P<\/jats:italic> = 0.002). Although it was not possible to define a subgroup that obtained a greater benefit from CQ according to anti\u2010SLA\/LP reactivity or HLA profile, 100% of patients who were anti\u2010SLA\/LP\u2010positive (+) relapsed with placebo compared to 50% with CQ (<jats:italic toggle=\"yes\">P<\/jats:italic> = 0.055). In the CQ group, 54.8% had side effects and 19.3% interrupted the drug regimen. <jats:italic toggle=\"yes\">Conclusion:<\/jats:italic> 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.<\/jats:p>","DOI":"10.1002\/hep4.1275","type":"journal-article","created":{"date-parts":[[2018,11,14]],"date-time":"2018-11-14T13:40:25Z","timestamp":1542202825000},"page":"116-128","source":"Crossref","is-referenced-by-count":17,"title":["Chloroquine Is Effective for Maintenance of Remission in Autoimmune Hepatitis: Controlled, Double\u2010Blind, Randomized Trial"],"prefix":"10.1097","volume":"3","author":[{"given":"D\u00e9bora","family":"Raquel Benedita Terrabuio","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas,University of S\u00e3o Paulo School of Medicine,S\u00e3o Paulo,Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcio","family":"Augusto Diniz","sequence":"additional","affiliation":[{"name":"Biostatistics and Bioinformatics Research Center,Samuel Oschin Comprehensive Cancer Institute, Cedars\u2010Sinai Medical Center,Los Angeles,CA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lydia","family":"Teofilo de Moraes Falc\u00e3o","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas,University of S\u00e3o Paulo School of Medicine,S\u00e3o Paulo,Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Luiza Vilar Guedes","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas,University of S\u00e3o Paulo School of Medicine,S\u00e3o Paulo,Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Larissa","family":"Akeme Nakano","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas,University of S\u00e3o Paulo School of Medicine,S\u00e3o Paulo,Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andr\u00e9ia","family":"Silva Evangelista","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas,University of S\u00e3o Paulo School of Medicine,S\u00e3o Paulo,Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fabiana","family":"Roberto Lima","sequence":"additional","affiliation":[{"name":"Department of Pathology,University of S\u00e3o Paulo School of Medicine,S\u00e3o Paulo,Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clarice","family":"Pires Abrantes\u2010Lemos","sequence":"additional","affiliation":[{"name":"Laboratory of Medical Investigation of Immunopathology of Schistosomiasis,Institute of Tropical Medicine of University of S\u00e3o Paulo,S\u00e3o Paulo,Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Flair","family":"Jos\u00e9 Carrilho","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas,University of S\u00e3o Paulo School of Medicine,S\u00e3o Paulo,Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eduardo","family":"Luiz Rachid Cancado","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Division of Clinical Gastroenterology and Hepatology, Hospital das Clinicas,University of S\u00e3o Paulo School of Medicine,S\u00e3o Paulo,Brazil"},{"name":"Laboratory of Medical Investigation of Immunopathology of Schistosomiasis,Institute of Tropical 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