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.