Combined therapy with azathioprine, prednisolone, and ursodiol in patients with primary sclerosing cholangitis. A case series.
BACKGROUND
No established medical therapy alters the progressive course of primary sclerosing cholangitis.


OBJECTIVE
To explore the potential usefulness of combined therapy with azathioprine, steroids and ursodeoxycholic acid (UDCA) in primary sclerosing cholangitis.


METHODS
Case series.


METHODS
University hospital in Mainz, Germany.


METHODS
15 patients with primary sclerosing cholangitis.


METHODS
Azathioprine (1 to 1.5 mg/kg of body weight per day), prednisolone (1 mg/kg per day initially, tapering to 5 to 10 mg per day) and UDCA (500 to 750 mg per day).


METHODS
Clinical and laboratory evaluation, liver biopsy, and endoscopic retrograde cholangiography (a >30% change in stenosis was considered significant).


RESULTS
After a median observation period of 41 months (range, 3 to 81 months), liver enzyme levels declined significantly in all patients. Six of 10 patients with follow-up liver biopsies showed histologic improvement. Significant radiographic deterioration was seen in only 1 of 10 patients who had endoscopic retrograde cholangiography. In 7 patients previously treated with UDCA alone, liver enzyme levels declined significantly only after immunosuppressive therapy was added. Adverse drug reactions led to the withdrawal of study medications in 2 patients.


CONCLUSIONS
Combined immunosuppressive therapy may alter the progression of primary sclerosing cholangitis. Our observations suggest a benefit from adding immunosuppressive drugs to UDCA therapy. A randomized trial is warranted.
Schramm
C
C
Johannes Gutenberg University, Mainz, Germany.
Schirmacher
P
P
Helmreich-Becker
I
I
Gerken
G
G
zum Büschenfelde
K H
KH
Lohse
A W
AW
D000328:Adult; D001379:Azathioprine / Q000627:therapeutic use*; D002756:Cholagogues and Choleretics / Q000627:therapeutic use*; D015209:Cholangitis, Sclerosing / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008099:Liver / Q000000981:diagnostic imaging / Q000201:enzymology / Q000473:pathology; D008297:Male; D010865:Pilot Projects; D011239:Prednisolone / Q000627:therapeutic use*; D011859:Radiography; D014580:Ursodeoxycholic Acid / Q000627:therapeutic use*
D002756:Cholagogues and Choleretics; D007166:Immunosuppressive Agents; D014580:Ursodeoxycholic Acid; D011239:Prednisolone; D001379:Azathioprine