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P360. Symptom resolution and clinical remission in patients with mild-to-moderate ulcerative colitis: analysis of the PODIUM trial

A. Dignass1, B. Bokemeyer2, M. Mross3, M. Oudkerk Pool4, 1Agaplesion Markus Hospital, Frankfurt, Germany, 2Gastroenterologische Gemeinschaftspraxis, Minden, Germany, 3Internistische Praxis, Berlin, Germany, 4Gelre Ziekenhuizen, Apeldoorn, Netherlands

Background

Among patients with ulcerative colitis (UC) in remission, non-compliance with prescribed medication is common and associated with a higher risk of disease relapse and the recurrence of distressing and unpleasant symptoms. For patients who have achieved remission, an important aspect of successful treatment is continued absence of clinical symptoms. The PODIUM trial investigated slow release 5-aminosalicylic acid (5-ASA) granules administered as 2g once-daily (OD) versus 1g twice-daily (BD) for the maintenance of remission of mild-to-moderate UC. Here, we examine separate clinical and endoscopic remission rates among patients enrolled to the PODIUM trial.

Methods

Patients with mild-to-moderate UC, who were in clinical remission (UC-DAI <2) at enrolment and had suffered a clinical relapse within the past year, were randomised to receive either 2g 5-ASA granules OD or 1g 5-ASA granules BD. The primary endpoint of PODIUM was remission rate (UC-DAI <2) at 12 months. In this subanalysis, clinical remission (UC-DAI subscore <2 for stool frequency and rectal bleeding) was assessed at 4 months, 8 months and at end of study; endoscopic remission (UC-DAI endoscopic subscore = 0) was assessed at end of study.

Results

362 patients were enrolled to the PODIUM trial (OD n = 175, BD n = 187). Clinical remission rates for the OD and BD arms were 97.9% (139/142, 95% confidence interval (CI) 94.0–99.6%) and 97.9% (137/140, 93.9–99.6%) after 4 months, 99.2% (123/124, 95% CI 95.6–100.0%) and 96.7% (116/120, 95% CI 91.7–99.1%) after 8 months and 79.0% (132/167, 95% CI 72.1–84.9%) and 68.7% (123/179, 95% CI 61.4–75.4%), respectively, at end of study. At enrolment, 54.3% (95/175) of patients in the OD arm and 58.6% (109/187) of patients in the BD arm were in endoscopic remission (UC-DAI endoscopic subscore = 0). Endoscopic remission rates at end of study were 49.4% (76/154, 95% CI 72.1–84.9%) for the OD arm and 46.5% (73/157, 95% CI 38.5–54.6%) for the BD arm.

Conclusion

The majority of patients maintained remission from clinical symptoms for up to 12 months with 5-ASA granules administered either OD or BD. Furthermore, almost all patients in endoscopic remission at enrolment maintained endoscopic remission over the study period.