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Final Report on a Placebo-Controlled, Double-Blind, Randomized, Multicentre Trial of Cyclosporin Treatment in Active Chronic Crohn's Disease

1991; Taylor & Francis; Volume: 26; Issue: 7 Linguagem: Inglês

10.3109/00365529108998585

1502-7708

Jørn Brynskov, L Freund, Sten Nørby Rasmussen, K. Lauritsen, Ove B. Schaffalitzky de Muckadell, C. N. Williams, A. S. Macdonald, R Tanton, Francisco Fidencio Cons Molina, Mauro Campanini, Paola Bianchi, T Ranzi, F. Quarto di Palo, A Malchow-Møller, Ole Østergaard Thomsen, Ulrik Tage‐Jensen, V. Binder, P Riis,

Microscopic Colitis

AbstractIn a previous report we published the immediate results of a 3-month placebo-controlled trial (n = 34) showing that cyclosporin (n = 37) has a beneficial therapeutic effect in active chronic Crohn's disease. Here we report on the final outcome of the patients. During the 3-month tapering-off period eight initially improved patients (36%) in the cyclosporin group worsened, as did six (55%) in the placebo group. The therapeutic gain of cyclosporin treatment was consistently significant during this period. It ranged from 22% to 25% (95% confidence limits, 2-46%). An outcome ranking showed that 7 patients of the cyclosporin group (19%) were substantially improved, 7 (19%) moderately improved, and 23 (62%) not improved after the tapering off. In contrast, no significant differences were seen during the 6-month follow-up period. Four patients of the cyclosporin group (11%) were substantially improved, 3 (8%) moderately improved, and 30 (81%) not improved at final follow-up. Significant interactions between cyclosporin and prednisolone treatment were demonstrated both at the end of the initial treatment period and at the end of the tapering-off period. We conclude that a short course of cyclosporin treatment does not result in long-term improvement in active chronic Crohn's diseaseKey Words: Crohn's diseasecyclosporininflammatory bowel disease