A new oral delivery system for 5-ASA: Preliminary clinical findings for MMx
Version of Record online: 14 DEC 2006
Copyright © 2005 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 11, Issue 5, pages 421–427, May 2005
How to Cite
Prantera, C., Viscido, A., Biancone, L., Francavilla, A., Giglio, L. and Campieri, M. (2005), A new oral delivery system for 5-ASA: Preliminary clinical findings for MMx. Inflamm Bowel Dis, 11: 421–427. doi: 10.1097/01.MIB.0000158386.25660.1e
- Issue online: 14 DEC 2006
- Version of Record online: 14 DEC 2006
- Manuscript Accepted: 24 JAN 2005
- Manuscript Received: 7 OCT 2004
- 5-aminosalicyclic acid;
- 5-aminosalicyclic acid multi-matrix;
- left-sided ulcerative colitis;
Background: Multi-matrix (MMx), a new delivery system for mesalazine, seems to release 5-aminosalicyclic acid (5-ASA) preferentially in the sigmoid colon. This study had 2 objectives: (1) to evaluate the therapeutic response to MMx in patients with active left-sided disease and (2) to gain additional insights as to how the therapy would compare with topical 5-ASA.
Methods: Patients received either 1.2 g of 5-ASA MMx three times per day plus placebo enema or 4 g of 5-ASA enema plus placebo tablets for 8 weeks. The primary endpoint was clinical remission (clinical activity index ≤4) at 8 weeks. Secondary endpoints were endoscopic and histologic remissions.
Results: Seventy-nine patients were enrolled. Clinical remission rates at 4 and 8 weeks were 57.5% and 60.0% for patients treated with MMx and 68.4% and 50.0% for patients randomized to 5-ASA enemas, respectively (95% confidence interval for the difference at 8 weeks, −12 to +32). Endoscopic remission was achieved by 45.0% of patients on 5-ASA MMx and by 36.8% of those on enema, whereas 15.0% and 8% of patients, respectively, showed histologic remission. Compliance was 97.0% for oral and 87.5% for topical therapy. In the enema group, compliance was 88.0% for the patients in remission and 65.5% for those with active disease.
Conclusions: Preliminary studies suggest that similar rates for induction of remission can be expected from 5-ASA enemas and MMx for patients with left-sided ulcerative colitis.