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P562. Comparing the efficacy of once-daily or twice-daily mesalazine dosing in the treatment of left-sided ulcerative colitis versus the overall MOTUS study population

B. Flourié1, J. Kuyvenhoven2, C. Probert3, O. Dewit4, 1Centre Hospitalo-Universitaire Lyon-Sud, Department of Gastroenterology, Lyon, France, 2Kennemer Gasthuis, Department of Gastroenterology and Hepatology, Haarlem, Netherlands, 3University of Liverpool, Liverpool, United Kingdom, 4UCL Saint Luc, Brussels, Belgium

Background

In the treatment of ulcerative colitis (UC), less frequent dosing of 5-aminosalicylic acid (5-ASA) simplifies treatment and improves compliance. The objective of MOTUS was to show that 4g once-daily (OD) dosing of Pentasa granules is non-inferior to standard 2 g twice-daily (BD) dosing for the induction of remission in active UC. As the majority of patients (pts) with UC experience left-sided disease, the aim of this subanalysis was to compare the efficacy of 5-ASA 4 g OD versus 2 g BD for induction of remission in left-sided UC versus the overall MOTUS study population.

Methods

Pts with active mild-to-moderate UC were randomised to receive 5-ASA granules 4 g/day: 2× 2 g OD or 1× 2 g BD. All pts also received 5-ASA enema (1 g/day) for the first 4 weeks. The primary endpoint was clinical and endoscopic remission at week 8 (UC disease activity index [UC-DAI] ≤1). Secondary endpoints included complete remission at week 8 (clinical and endoscopic remission with UC-DAI = 0) and mucosal healing at week 8 (UC-DAI endoscopic subscore ≤1). Subgroup analyses of the primary endpoint were carried out by disease location (left-sided disease versus overall study population). Statistical data were based on intent-to-treat analyses. If the lower limit of the 95% confidence interval (CI) was -15-0%, then the OD regimen was declared non-inferior to the BD regimen.

Results

206 pts were enrolled (OD n = 102, BD n = 104). Of the overall population, 83% had left-sided or distal UC and 17% had pancolitis or extensive UC. Pts with left-sided/distal UC comprised 81.4% of the OD arm (n = 82) and 84.6% of the BD arm (n = 86). The primary endpoint of clinical and endoscopic remission at week 8 (UC-DAI ≤ 1) was achieved by 52.9% and 41.5% of pts with left-sided/distal UC in the OD arm and the BD arm, respectively (lower 95% CI limit −3.7%). These remission rates are comparable to those of the overall study population (OD 52.1%, BD 41.8%). For pts with left-sided/distal UC, non-inferiority was also demonstrated for the secondary endpoints of complete remission (UC-DAI = 0; OD 28.0%, BD 24.4%, lower 95% CI limit −9.9%) and mucosal healing (endoscopic subscore UC-DAI ≤1; OD 86.6%, BD 68.2%, lower 95% CI limit −5.0%) at week 8.

Conclusion

These results show that OD treatment with 5-ASA is at least as effective as BD dosing and has similar efficacy in pts with left-sided UC compared to those in the overall MOTUS trial population with regard to inducing clinical and endoscopic remission.