Objective: To evaluate the efficacy and the safety of long-term azathioprine maintenance therapy in a group of Chinese patients with Crohn's disease.
Methods: The efficacy of azathioprine (2.0 mg/kg/day) in controlling the disease relapse in 13 patients with Crohn's disease following clinical remission by prednisone or surgery were investigated. The Crohn's disease activity index (CDAI) and the Harvey-Bradshaw index, the reduction of steroid dosage and side-effects for an average of 18 months follow up were analyzed.
Results: Azathioprine was effective in controlling the disease relapse in 10 (by CDAI scores) or 11 (by Harvey -Bradshaw index) of 13 patients (76.9% and 84.6%, respectively) for at least 6 months. Azathioprine was not discontinued in a patient who experienced a temporary and mild elevation of aminotransferases 14 months after the initiation of therapy. However one patient who was co-administered with azathioprine and mesalamine (Pentasa) developed an episode of bone marrow suppression that ultimately required the withdrawal of both medications.
Conclusion: Azathioprine is an effective agent which controls the relapse of Crohn's disease in most patients. Long-term remission can be achieved. Side-effects, including severe leukopenia, myelo-suppression and the mild elevation of hepatic enzymes, may occur in a small number of patients.