Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial

Summary

The gold-standard treatment of Autoimmune hepatitis (AIH), with prednisone alone or in conjunction with azathioprine can reach resolution of the disease in 70-80% of the cases in US. However, in Brazil the response to these treatments seems to be worse, approximately 35% in five years. Because of the side effects of the gold-standard treatment and the need for an alternative option for the no responsive patients, news drugs must be evaluated for this proposal. Chloroquine diphosphate is an antimalarial drug that has been used for the treatment of rheumatological diseases for at the least five decades. Chloroquine was used as a single drug for up to two years for the maintenance of AIH remission in an open study. There was a 6.49 greater chance of relapse in the historical controls when compared with patients treated with chloroquine (72.2% x 23.5%; p = 0.031). The aim of this study was to investigate whether chloroquine in conjunction with prednisone can be used as an alternative treatment of AIH in a randomized study, and to evaluate its side effects.

Timeline

Start

2003-05

Primary completion

2015-06

Completion

2016-07

Publications

• T de Moraes Falcao L, Terrabuio DRB, Diniz MA, da Silva Evangelista A, Souza FG, R Cancado EL. Efficacy and safety of chloroquine plus prednisone for the treatment of autoimmune hepatitis in a randomized trial. JGH Open. 2019 Sep 10;4(3):371-377. doi: 10.1002/jgh3.12258. eCollection 2020 Jun.

Drugs

Indications