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Previous Volume 339:370-374 August 6, 1998 Number 6 Next

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ABSTRACT

Background Crohn's disease is often treated with glucocorticoids or mesalamine. We compared the efficacy and safety of controlled-ileal-release budesonide capsules and slow-release mesalamine tablets in patients with active Crohn's disease affecting the ileum, the ascending colon, or both.

Methods In a double-blind, multicenter trial, we enrolled 182 patients with scores of 200 to 400 on the Crohn's Disease Activity Index (with higher scores indicating greater disease activity) and randomly assigned 93 to receive 9 mg of budesonide once daily and 89 to receive 2 g of mesalamine twice daily for 16 weeks. The primary efficacy variable was clinical remission, defined as a score of 150 or less on the Crohn's Disease Activity Index.

Results In the analysis of all patients who received at least one dose of study drug, the rates of remission after 8 weeks of treatment were 69 percent in the budesonide group and 45 percent in the mesalamine group (P=0.001); the respective rates after 16 weeks of treatment were 62 percent and 36 percent (P<0.001). Seventy-seven patients in the budesonide group completed the 16 weeks of treatment, as compared with 50 patients in the mesalamine group (P<0.001). The numbers of patients with adverse events were similar in the two groups, but those assigned to budesonide had fewer severe adverse events. Among patients who completed 16 weeks of treatment, the morning plasma cortisol value was normal in 67 percent of budesonide-treated patients and 83 percent of mesalamine-treated patients (P=0.06); 90 percent and 100 percent, respectively, had normal increases in cortisol in response to cosyntropin (P=0.02).

Conclusions In patients with active Crohn's disease affecting the ileum, the ascending colon, or both, a controlled-ileal-release formulation of budesonide was more effective in inducing remission than a slow-release formulation of mesalamine.

Source Information

From the Department of Medical Gastroenterology C, Herlev Hospital, University of Copenhagen, Herlev, Denmark (O.Ø.T.); the Gastroenterology Service, Hôpital Claude Huriez, Lille, France (A.C.); the Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom (D.J.); the Gastrointestinal Clinic, Kingsbury Hospital (J.P.W.), and the Department of Gastroenterology, Groote Schuur Hospital (T.W.), Cape Town, South Africa; the Gastroenterology Department, Hospital de S. João, Porto, Portugal (F.T.V.); the Department of Medicine, Rikshospitalet, Oslo, Norway (M.V.); and Clinical Research and Development, Astra Draco, Lund, Sweden (T.P., E.P.).

Address reprint requests to Dr. Thomsen at the Department of Medical Gastroenterology C, Herlev Hospital, University of Copenhagen, DK-2730 Herlev, Denmark.

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