Ursodeoxycholic acid has been ineffective in the treatment of primary sclerosing cholangitis.
The pathogenesis of primary sclerosing cholangitis is related to immune destruction of bile duct epithelium, hence several immune suppressive agents have been evaluated.
Mycophenolate mofetil is a potent immunosuppressant that is now widely used in organ transplantation.
Dr Sterling and colleagues from Virginia, America undertook a prospective, randomized controlled pilot study to evaluate mycophenolate mofetil when combined with ursodeoxycholic acid.
The researchers aimed to discover if this combined therapy could prevent evidence of clinical progression and improve the biochemical, histological and/or cholangiographic features of primary sclerosing cholangitis compared with patients treated with ursodeoxycholic acid alone.
The research group randomly picked 25 patients with well-defined primary sclerosing cholangitis to receive ursodeoxycholic acid (13-15 mg/kg/day) with or without mycophenolate mofetil (1000 mg b.d.).
|After 2 years, there was no difference histological stage or cholangiograms between patients on combined or single therapy|
|Alimentary Pharmacology and Therapeutics|
The investigators performed cholangiography and liver biopsy at study entry and then again after 2 years of treatment.
The research group then monitored symptoms, clinical features of liver disease and biochemical tests at 3-month intervals.
The mean age of the participants was recorded as 44 years, 58% of patients were male, 84% Caucasian and 64% had ulcerative colitis.
The researchers noted that after 2 years, there were no differences in laboratory values, histological stage or cholangiograms between patients treated with ursodeoxycholic acid alone and those treated with mycophenolate mofetil + ursodeoxycholic acid.
Dr Sterling, speaking on behalf of the authors concluded, "Mycophenolate mofetil combined with ursodeoxycholic acid does not appear to provide additional benefit compared with standard doses of ursodeoxycholic acid alone in the treatment of primary sclerosing cholangitis."