Open Trial of Cyclosporine in Patients with Severe Active Crohn's Disease Refractory to Conventional Therapy

Fifteen patients with severe active Crohn's disease, refractory to conventionaltherapy, were given a 16 week course of cyclosporine ar an initial oral dailydose of 10 mg/kg, adjusted to maintain cyclosporine scrum trough levels between 100and 200 ng/ml. Five patients withdrew early because of side effects, poor absorption ornoncompliance. T he remaining 10 patients all improved within four weeks asmeasured by three different clinical indices: Crohn's Disease Activity Index, SimpleIndex of Crohn's Disease Activity and Mean Score of Therapeutic Goals (MSTG).Seven patients maintained this initial improvement and prednisone was eitherreduced or discontinued. Four of these seven patients relapsed with in four weeks ofstopping cyclosporine, and three remain in remission after 75 ± 2 weeks. Side effectswere minor and easily reversible. When the various clinical and laboratory indiceswere compared, MSTG was found to be the most useful index for the assessment oftherapy. Cyclosporine appears to be a safe and effective therapy in patients with severeactive Crohn's disease refractory to conventional therapy