Reuters Health Information (2011-02-02): Mycophenolate mofetil helps avoid steroids for autoimmune hepatitis
Drug & Device Development
Mycophenolate mofetil helps avoid steroids for autoimmune hepatitis
Last Updated: 2011-02-02 16:58:24 -0400 (Reuters Health)
NEW YORK (Reuters Health) - Mycophenolate mofetil appears particularly safe and effective in treatment-naive patients with autoimmune hepatitis, Greek researchers report.
Dr. George N. Dalekos of the University of Thessaly, Larissa and colleagues note that patients ordinarily receive corticosteroids with or without azathioprine. About 20% of patients do not respond or are intolerant.
Moreover, steroid associated side effects are significant. And at least 10% of patients taking azathioprine develop nausea, vomiting, rash, cytopenia, pancreatitis or cholestasis.
The Greek team treated 59 patients with prednisolone plus mycophenolate mofetil, 1.5 to 2 g/day. Primary end points were treatment response (complete, partial or no response or relapse), and secondary end points were the improvement of AST, ALT, gamma globulins and/or serum levels from baseline to the end of treatment, and the incidence of steroid withdrawal.
Fifty-two patients (88%) had complete biochemical and clinical responses, usually within 3 months. The remaining 7 patients had partial responses, the authors reported online January 14th in the Journal of Hepatology.
Mean mycophenolate treatment duration was 26 months. In total, 59.3% had complete responses without relapse, and 37.0% did so off of prednisolone. A further 28.8% had an initial complete remission with relapses.
Corticosteroids were withdrawn in 34 patients (57.6%) after a median of 8 months. In the 43 patients who were treated for more than 12 months, the frequency of prednisolone withdrawal was 70%.
Severe side effects leading to mycophenolate discontinuation occurred in only 2 patients, both of whom had septicemia. Overall, 6 patients stopped mycophenolate treatment, but 3 relapsed.
Given these favorable results, the team stresses that mycophenolate mofetil "has to be rigorously investigated as potentially the preferable first-line therapy for the treatment of autoimmune hepatitis."
In fact, they conclude that there's an urgent need "to confirm definitely the potential advantage of mycophenolate mofetil-based treatment."
J Hepatol 2011.