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Title: Efficacy and Safety of Mycophenolate Mofetil in Patients With Autoimmune Hepatitis and Suboptimal Outcomes After Standard Therapy.
Austin Authors: Roberts, Stuart K;Lim, Ricky;Strasser, Simone;Nicoll, Amanda;Gazzola, Alessia;Mitchell, Joanne;Siow, Way;Khoo, Tiffany;Hamarneh, Zaki;Weltman, Martin;Gow, Paul J ;Janko, Natasha;Tse, Edmund;Mishra, Gauri;Cheng, En-Hsiang;Levy, Miriam;Cheng, Wendy;Sood, Siddharth ;Skoien, Richard;Mitchell, Jonathan;Zekry, Amany;George, Jacob;MacQuillan, Gerry;Wigg, Alan;Stuart, Katherine;Sievert, William;McCaughan, Geoffrey
Affiliation: The Alfred, Melbourne
Royal Prince Alfred Hospital, Sydney
Eastern Health, Box Hill Hospital, and Monash University, Box Hill
Storr Liver Centre, Westmead Institute for Medical Research, Westmead Hospital and University of Sydney, Sydney
Flinders Medical Centre, Adelaide
Nepean Hospital, Sydney
Austin Health, Heidelberg, Victoria, Australia
Royal Adelaide Hospital, Adelaide
Monash Medical Centre and Monash University, Melbourne
Princess Alexandra Hospital, Brisbane
Liverpool Hospital, Sydney
Royal Perth Hospital, Perth
Royal Melbourne Hospital, Melbourne
Royal Brisbane and Women's Hospital, Brisbane
Nambour General Hospital, Nambour
St George Hospital, Sydney, Australia
Sir Charles Gairdner Hospital, Perth
Centenary Research Institute, Sydney
Issue Date: Feb-2018 2017-10-16
Publication information: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association 2018; 16(2): 268-277
Abstract: 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. 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. 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. 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.
DOI: 10.1016/j.cgh.2017.09.063
PubMed URL: 29050991
Type: Journal Article
Subjects: Immune Suppressant
Periportal Hepatitis
Appears in Collections:Journal articles

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