Eleven trials were included in the review (n=578). Jadad scores ranged from 1 to 4.
Induction: (seven RCTs: three treatment naive, two relapse and two combination)
In treatment-naive patients, remission rate for PRED was 42% (three RCTs, n=95), for PRED plus azathioprine was 43% (two RCTs, n=44) and for azathioprine alone was 14% (four RCTs, n=51). In autoimmune hepatitis patients who relapsed, the remission rate for PRED was 32% (two trials, n=34). No statistically significant differences were found in remission between induction therapy with PRED and PRED plus azathioprine in treatment-naive patients and patients who relapsed.
In treatment-naive patients, mortality rate for PRED was 15% (five RCTs, n=139) for PRED plus azathioprine was 7% and for azathioprine alone was 30% (four RCTs, n=89). In autoimmune hepatitis patients who relapsed, the mortality rate for PRED was 4% (three trials, n=34).
Maintenance therapy: (four RCTs)
PRED plus azathioprine (RR 1.40, 95% CI 1.13 to 1.73; three RCTs, n=177) and azathioprine alone (RR 1.35, 95% CI 1.07 to 1.70; three RCTs, n=139) maintained remission more often than PRED alone. No significant difference was found between PRED plus azathioprine and azathioprine alone on maintenance of remission.
Adverse events:
Adverse events associated with PRED included cushingoid appearance, diabetes mellitus, hypertension and cataracts. Adverse events associated with azathioprine included gastrointestinal bleeding, leucopenia, thrombocytopaenia and arthralgia. Cushingoid appearance and diabetes mellitus were associated with combined PRED plus azathioprine treatment, but in lower frequency than was found in PRED monotherapy.