Efficacy and Safety of Mycophenolate Mofetil in Patients With Autoimmune Hepatitis and Suboptimal Outcomes After Standard Therapy

Efficacy and Safety of Mycophenolate Mofetil in Patients With Autoimmune Hepatitis and Suboptimal Outcomes After Standard Therapy.

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Item Type: Article
Status: Published
Official URL: https://doi.org/10.1016/j.cgh.2017.09.063
Journal or Publication Title: Clinical Gastroenterology and Hepatology
Volume: 16
Number: 2
Page Range: pp. 268-277
Date: 2018
Divisions: Liver Injury and Cancer
Depositing User: General Admin
Identification Number: 10.1016/j.cgh.2017.09.063
ISSN: 15423565
Date Deposited: 03 Jan 2021 23:05
Abstract:

Background & aims: Little is known about outcomes of patients with autoimmune hepatitis (AIH) who have a suboptimal outcome to standard therapy and are then given mycophenolate mofetil as rescue therapy. We evaluated the efficacy and safety of mycophenolate mofetil in patients failed by or intolerant to corticosteroids, with or without azathioprine.

Methods: We performed a retrospective study of 105 patients with AIH who received mycophenolate mofetil therapy after an inadequate response or intolerance to standard therapy (98% received combination therapy with corticosteroids plus thiopurines). Patients were recruited from 17 liver clinics via the Australian Liver Association Clinical Research Network. We reviewed records for baseline demographic features and characteristics of liver disease, initial therapy, mycophenolate mofetil indications, treatment outcome, and side effects. The primary outcome was biochemical remission, defined as levels of alanine and aspartate transferase and IgG level within the normal reference range, with or without normal liver histology within the first 2 years of treatment.

Results: The indication for mycophenolate mofetil therapy was non-response to treatment for 40% of cases and intolerance to therapy for 60%. Overall, 63 patients (60%) achieved biochemical remission following a median 12 weeks treatment with mycophenolate mofetil. The proportion of patients who achieved biochemical remission was similar between patients receiving mycophenolate mofetil for non-response to standard therapy (57%) and patients with intolerance to standard therapy (62%). However, a lower proportion of patients with cirrhosis achieved biochemical remission (47%) than patients without cirrhosis (6%) (P = .07). Serious adverse events occurred in 3 patients (2.7%) including 1 death, and 10 patients (9.2%) discontinued mycophenolate mofetil because of adverse events.

Conclusion: In this retrospective study of patients with AIH who received mycophenolate mofetil as a rescue therapy, we found the drug to be well tolerated and moderately effective, inducing biochemical remission in 60% of subjects. Rates of response are lower and rates of infection are higher in patients with AIH and cirrhosis. Prospective studies of mycophenolate mofetil are warranted for this population.

Keywords: Immune Suppressant; Inflammation; Periportal Hepatitis; TAPESTRY Study.

Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

Creators:
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Roberts, Stuart K.
UNSPECIFIED
Lim, Ricky
UNSPECIFIED
Strasser, Simone
UNSPECIFIED
Nicoll, Amanda
UNSPECIFIED
Gazzola, Alessia
UNSPECIFIED
Mitchell, Joanne
UNSPECIFIED
Siow, Way
UNSPECIFIED
Khoo, Tiffany
UNSPECIFIED
Hamarneh, Zaki
UNSPECIFIED
Weltman, Martin
UNSPECIFIED
Gow, Paul
UNSPECIFIED
Janko, Natasha
UNSPECIFIED
Tse, Edmund
UNSPECIFIED
Mishra, Gauri
UNSPECIFIED
Cheng, En-Hsiang
UNSPECIFIED
Levy, Miriam
UNSPECIFIED
Cheng, Wendy
UNSPECIFIED
Sood, Siddharth
UNSPECIFIED
Skoien, Richard
UNSPECIFIED
Mitchell, Jonathan
UNSPECIFIED
Zekry, Amany
UNSPECIFIED
George, Jacob
UNSPECIFIED
MacQuillan, Gerry
UNSPECIFIED
Wigg, Alan
UNSPECIFIED
Stuart, Katherine
UNSPECIFIED
Sievert, William
UNSPECIFIED
McCaughan, Geoffrey
UNSPECIFIED
Last Modified: 03 Jan 2021 23:05
URI: https://eprints.centenary.org.au/id/eprint/487

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