Olsalazine is not superior to placebo in maintaining remission of inactive Crohn's colitis and ileocolitis: a double blind, parallel, randomised, multicentre study

N Mahmud ¹, M A Kamm , J L Dupas

⁰Department of Clinical Medicine, Trinity College, St James's Hospital, Dublin, Ireland. nmahmud@tcd.ie

Gut +

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September 18, 2001

View abstract on PubMed

Summary

Olsalazine did not prevent relapse in Crohn's disease patients but led to more gastrointestinal side effects and study withdrawals compared to placebo. Patients on olsalazine were more likely to quit the trial due to adverse events.

Area Of Science

Gastroenterology
Clinical Pharmacology
Inflammatory Bowel Disease Research

Background

The efficacy of 5-aminosalicylic acid therapies for maintaining remission in Crohn's disease remains debated.
Olsalazine, a prodrug of 5-ASA, has been investigated for its potential prophylactic role.

Purpose Of The Study

To assess the effectiveness of olsalazine compared to placebo in maintaining remission for patients with quiescent Crohn's colitis and/or ileocolitis.
To evaluate the safety and tolerability profile of olsalazine in this patient population.

Main Methods

A randomized, double-blind, parallel-group study involving 328 patients with quiescent Crohn's disease.
Patients received either 2.0 g of olsalazine daily or a placebo for 52 weeks.
Efficacy endpoints included relapse rates (CDAI and clinical), while safety was monitored through adverse events and laboratory values.

Main Results

No significant difference in relapse rates or time to relapse was observed between the olsalazine and placebo groups.
Significantly higher overall failure rates (study withdrawal) were noted in the olsalazine group (65.4%) compared to placebo (53.9%).
Adverse gastrointestinal events were more frequent in the olsalazine group, leading to more early withdrawals and a shorter average study duration.

Conclusions

Olsalazine treatment did not demonstrate a benefit in preventing Crohn's disease relapse compared to placebo.
Intolerable gastrointestinal adverse events, rather than disease relapse, were the primary reason for increased study termination in the olsalazine group.
The findings suggest olsalazine may not be an effective maintenance therapy for Crohn's disease due to tolerability issues.

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