Induction and maintenance of remission with the use of long-term oral cyclosporine therapy in severe, steroid-refractory ulcerative or Crohn colitis

Oral cyclosporine therapy has proven to be an alternative to emergency colectomy in steroid-refractory colitis. The therapeutic value, optimal dosage and long-term efficacy and safety of this formulation have not been well studied. The aim of this study was to investigate the clinical outcome of patients with steroid-resistant severe colitis treated with Sandimmune Neoral (Novartis) controlled by a two-point sampling time method.

Patients and methods: During the past 4 years, 30 patients were treated with oral cyclosporine because of severe active colitis (21 females, 9 males; mean age: 40,3 years; 26 patients with ulcerative colitis, 3 with Crohn's disease and 1 with indeterminate colitis; localization: 25 pancolitis, 5 left-side colitis). After the induction of remission (if this was possible), the administration of the drug was continued for at least a year. The dose of corticosteroid was gradually reduced, and a 2mg/bw/kg dose of azathioprine was initiated during the cyclosporine treatment. The primary objectives of the study were to ascertain the induction of remission and the frequencies of relapse during the next 12 months and colectomy-free survival.

Results: All patients improved within 14 days and complete remission was achieved in 24/30 patients after 3 months. 3 patients were operated on during the first and 2 during the second 6 months. 19 of the other 25 patients remained in remission during the one year of therapy, while the other 6 exhibited mild remission. There were 4 adverse events.

Discussion: Oral cyclosporine seems to be effective in the treatment of severe steroid-refractory colitis, not only for the induction but (in combination with azathioprine) also for maintenance of the remission. It appears that colectomy can be avoided in most patients through the prolonged use of oral cyclosporine.