Long Term Results of Use of Azathioprine in Patients with Ulcerative Colitis in India

Aim: To evaluate the role of azathioprine (AZA) in Indian patients with ulcerative colitis over longer duration of time.

Methods: One hundred fifty six patients with ulcerative colitis who were treated with AZA from January 1995 to December 2003 were reviewed. The indications for its use were as follows: (1) steroid dependent and steroid refractory disease; (2) Azathioprine monotherapy for naive patients with severe disease; and (3) combination therapy (AZA + sulfasalazine or 5-aminosalicylates) for naive patients with severe disease. The data included patient and disease demographics, efficacy and toxicity profile of AZA. Patients with a minimum duration of 6 mo use of AZA were included in this report.

Results: Of a total of 156 patients treated with AZA, 45 were excluded from analysis for the following reasons- (follow up less than 6 mo, n = 9; poor follow up, n = 18; adverse affects, n = 18). In steroid refractory/dependent group the mean number of relapses prior to and post initiation of AZA therapy were 3.28 (+/- 0.81) and 0.94 (+/- 0.29) respectively. Discontinuation of steroids could be accomplished in 12 of the 15 steroid dependent patients. The proportion of patients with sustained remission of 1, 2, 3, 4 and 5 years duration were calculated. Eighteen patients experienced adverse effects necessitating withdrawal of AZA (pancreatitis, n = 7; hepatitis, n = 3; gastrointestinal intolerance, n = 2; alopecia, n = 2; and hematological, n = 4) while 13 patients needed dose reduction or temporary withdrawal of the drug.

Conclusion: Azathioprine is well tolerated and has therapeutic benefits lasting as long as 4 years. Adverse effects such as pancreatitis, hepatitis, cytopenias and gastrointestinal symptoms do occur but are controlled by drug withdrawal only.