Clinical Trial: Evaluating a Single 1600 mg Tablet Regimen of 5-Aminosalicylate for Ulcerative Colitis—The EASI Trial

Background

5-Aminosalicylate (5-ASA) is recommended for the treatment of mild-to-moderate ulcerative colitis (UC). However, adherence may be low; poor adherence is associated with an increased risk for flares.

Aim

To investigate whether a regimen of a single 1600 mg tablet of 5-ASA improves adherence with preserved remission rates compared to a conventional regimen of three 800 mg tablets.

Methods

We enrolled 178 patients with UC (89 per group) in this open-label randomised controlled phase IV trial. Patients had to have stable remission on 5-ASA for at least 2 months and no concomitant diseases that could affect compliance. We randomised patients (1:1) to either receive Asacol 1600 mg single tablet or Asacol 2400 mg (three tablets of 800 mg once daily) for 12 months. Patients were assessed five times during the 12 months, where medicine was delivered and received, blood and stool samples were collected and symptom scores were determined.

Results

Eighty-two patients taking a single tablet and 78 taking three tablets were adherent (p = 0.32). Fewer patients in the 1600 mg group missed doses (24.5 vs. 26.5). There was no difference in the number of relapses or proportions experiencing relapse. Neither adherence nor treatment group was a significant predictor of relapse.

Conclusion

The single-tablet lower dose treatment could be a feasible alternative to the conventional three-tablet regimen.

Trial Registration

The study was registered at Clinicaltrials.gov (ID NCT04133194) and approved by The Danish Medicine Agency and The National Committee on Health Research Ethics (EudraCT 2019-002070-31)