Long‐Term Management of Crohn's Disease with Mesalamine Capsules (PentasaR)

Stephen B. Hanauer*, Edward I. Krawitt, Malcolm Robinson, Gregory G. Rick, Michael A. Safdi, and the Pentasa Crohn's Disease Compassionate Use Study Group, and the Pentasa Crohn's Disease Compassionate Use Study Group, and the Pentasa Crohn's Disease Compassionate Use Study Group, and the Pentasa Crohn's Disease Compassionate Use Study Group, and the Pentasa Crohn's Disease Compassionate Use Study Group

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

51 Scopus citations

Abstract

Current long‐term treatment of Crohn's disease is unsatisfactory. Based on the Crohn's Disease Activity Index (CDAI), this multicenter trial enrolled patients with either active Crohn's disease (CDAI ≥ 150) or disease in remission (CDAI < 150). The primary measure of therapeutic response was mean change in CDAI from baseline to final visit. All patients began treatment with a dosage of ≤ 4 g/day of mesalamine that ranged from 3.7 g at baseline to 3.4 g at final visit. Overall, 467 patients were enrolled: 333 (active disease) and 134 (remission). The median study participation time was 14 months. For patients entering with active disease, the mean reduction in CDAI was 77 points, with 42% (122/289) achieving remission by their final visit. For patients entering in remission, there was an increase in mean CDAI from 90 at baseline to 96 at final visit, with 79% (95/120) of patients in remission at final visit and 72% (31/43) in remission continuously after 12 months of therapy. From baseline to final visit, the mean prednisone dose decreased 5 mg/day in patients with active disease and 11 mg/day in patients in remission. Mesalamine was well tolerated and no adverse laboratory trends were observed. These results suggest that controlled‐release mesalamine shows promise as a steroid‐sparing agent and as a safe and effective long‐term therapy for the induction of and maintenance of remission of mild‐to‐moderate Crohn's disease.

Original languageEnglish (US)
Pages (from-to)1343-1351
Number of pages9
JournalThe American journal of gastroenterology
Volume88
Issue number9
DOIs
StatePublished - Sep 1993

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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