Early experiences with azathioprine in ulcerative colitis; a note of caution

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Abstract
Azathioprine was administered to 10 patients with ulcerative colitis classified as "very severe" in two, "moderately severe" in 7 and "relatively mild" in one patient, in conjunction with "standard" therapy and adrenal corticosteroids in 8 of the 10 patients. The possible beneficial therapeutic effects of azathioprine in this small series cannot be evaluated definitvely because of the concurrent medication and the preliminary uncontrolled observations. However, clinical improvement was apparent in 8 of the 10 patients; and in 2 patients, the favorable course occurred in the absence of steroid therapy. In 2 additional patients, the favorable course was maintained during the administration of azathioprine following the discontinuance of prolonged steroid therapy. In one patient, the administration of azathioprine was associated with amelioration of an arthritis and pyoderma gangrenosum which did not respond to the use of steroids and other medication. Immunosuppressive observations were limited. The established delayed hypersensitivity response, as reflected in various skin tests, was unchanged during the administration of azathioprine. Azathioprine had no discernible toxic effects upon the kidneys or the liver in 2 patients, one with postnecrotic cirrhosis and the other with serum hepatitis. Gastrointestinal symptoms (anorexia, epigastric discomfort, and nausea) occurred in 8 patients. Mild to moderate leukopenia developed in 8 patients and, in 2 individuals, was accompanied by thrombocytopenia. Temporary alopecia occurred in one woman. The hematopoietic effects developed within 2 or 3 weeks of therapy with azathioprine at a dosage level of 4 to 6 mg/kg/day. Azathioprine does not exert the rapid beneficial effect in ulcerative colitis noted with cortcotropin and adrenal corticosteroids. Therefore, its use in severe ulcerative colitis requiring intensive therapy probably is undesirable. Azathioprine, on the basis of these initial observations, may be considered for moderately sever ulcerative colitis, under circumstances permitting controlled and prolonged therapeutic trial as adjunct medication, but with careful supervision for prevention of toxicity, especially leukopenia.