Randomised Controlled Trial of Azathioprine Withdrawal in Autoimmune Chronic Active Hepatitis

Treatment options for autoimmune hepatitis: A systematic review of randomized controlled trials

“…Of these articles, the reference lists were checked, and this strategy resulted in 5 additional articles that fulfilled the inclusion criteria. Thus, a total of 11 RCTs were included for further analyses [7][8][9][12][13][14][15][16][17][18][19] of which 7 studies evaluated the induction therapy in AIH patients: 3 treatment naive (n = 253), 2 relapse (n = 53), 2 combination of naive and relapse (n = 110). The remaining 4 studies (n = 162) assessed maintenance therapy.…”

“…We identified 4 clinical trials that focused on AIH patients in remission on maintenance therapy (Table 3) [12,13,16,19]. These studies included 162 patients in 6 different arms, of which 22% were male.…”

Remission of experimental autoimmune hepatitis is associated with antigen-specific and non-specific immunosuppression

“…In some patients fluctuations of iransaminase levels before initialion of immunosuppressive therapy are observed, suggesting that the underlying autoimmune reactions are to some degree controlled by peripheral immunoregulatory mechanisms. Stable remissions in some patients even without immunosuppressive Iherapy also argue for the presence of immunoregulatory control mechanisms [5,6], As these mechanisms are at present not clearly documented or understood, we have attempted to approach the sludy of such regulatory control by investigating further our model of EAH, in which spontaneous subsiding of disease aelivity at a predictable time period is known and doeumenled, thus allowing sludy under defined conditions. In this study we could now show ihat recovery in EAH is characteristically associated with marked suppressor activity, whieh is both antigen-specific and non-specific.…”

Current and novel immunosuppressive therapy for autoimmune hepatitis

“…27 In a separate study, azathioprine was stopped in 27 patients and prednisolone was continued at maintenance doses of 5 to 12.5 mg/d. 28 Cumulative probability of relapse within 3 years was 32% in patients who stopped azathioprine, compared with 6% in 23 patients who continued on combination therapy. In a further trial, 48 patients were randomized to receive a higher dose of azathioprine (2 mg/kg/d) after the withdrawal of prednisolone or to continue with conventional maintenance therapy.…”