Azathioprine is useful in maintaining long-term remission induced by intravenous cyclosporine in steroid-refractory severe ulcerative colitis

Therapeutic regimens with intravenous (i.v.) cyclosporine followed by oral cyclosporine maintenance therapy reduce the need for immediate surgery in steroid-refractory severe ulcerative colitis, but the short-term colectomy rate is still as high as 70%. We report our experience with long-term azathioprine maintenance therapy in a small series of ulcerative colitis patients with i.v. cyclosporine-induced remission.

Twelve of thirteen patients with severe ulcerative colitis refractory to i.v. prednisone (1 mg/kg/day for at least 10 days) went into remission after adding i.v. cyclosporine (4 mg/kg/day) and are the subjects of this report. After a discouraging initial experience with oral cyclosporine plus mesalazine as maintenance therapy in the first four patients, we treated the following patients with azathioprine plus mesalazine starting immediately after response to i.v. cyclosporine was obtained. Overall, only 1 of 10 patients treated with azathioprine relapsed after a mean follow-up of 16.3 months (range: 6-48). Moreover, this relapse probably occurred when the drug was still not therapeutically active because, after reinducing remission with oral prednisone, the patient remained symptomless on azathioprine. Steroids could be discontinued in all patients.

The relapse rate on maintenance therapy with azathioprine (10%) is a figure considerably lower than that previously reported with oral cyclosporine. This promising experience should be confirmed in randomized controlled trials.