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. 2018 Feb;6(1):138-147.
doi: 10.1177/2050640617703842. Epub 2017 Mar 30.

Efficacy and safety of a novel high-dose mesalazine tablet in mild to moderate active ulcerative colitis: a double-blind, multicentre, randomised trial

Axel Dignass  1 , Robert Schnabel  2 , Jacek Romatowski  3 , Vladimir Pavlenko  4 , Andrey Dorofeyev  5 , Jelena Derova  6 , Laimas Jonaitis  7 , Karin Dilger  8 , Tanju Nacak  9 , Roland Greinwald  9 ; International SAT-25 Study Group
Affiliations

Efficacy and safety of a novel high-dose mesalazine tablet in mild to moderate active ulcerative colitis: a double-blind, multicentre, randomised trial

Axel Dignass et al. United European Gastroenterol J. 2018 Feb.

Abstract

Background: Adherence to mesalazine treatment is essential for the successful treatment of ulcerative colitis.

Objective: The objective of this study was to compare the efficacy, safety and preference of a novel high-dose 1000 mg mesalazine tablet versus conventional treatment for ulcerative colitis remission.

Methods: This pivotal phase III trial compared one 1000 mg mesalazine tablet (M1000 group) versus two registered 500 mg mesalazine tablets (M2x500 group), both taken three times daily, in patients with mild to moderately active ulcerative colitis. The primary efficacy variable was clinical remission at week 8.

Results: A total of 306 patients were considered for intent-to-treat analysis. Clinical remission was achieved in 45.0% of the patients in the M1000 group versus 41.9% in the M2x500 group (P < 0.001 for non-inferiority). Mucosal healing was achieved by 68.9% of the patients in the M1000 group and 68.4% in the M2x500 group. The majority of patients preferred the intake of one high-dose tablet (47.7%) over two low-dose tablets (10.5%). Oral treatment with high-dose 1000 mg mesalazine tablets was well tolerated without new safety signals.

Conclusions: The novel high-dose 1000 mg mesalazine tablet is effective, non-inferior to the registered 500 mg mesalazine tablet, and safe for ulcerative colitis treatment. It was preferred by a majority of patients and may improve ulcerative colitis treatment adherence.

Keywords: Mesalazine; adherence; efficacy; randomised; ulcerative colitis.

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Figures

Figure 1.
Figure 1.
Patient disposition. PP: per protocol.
Figure 2.
Figure 2.
Clinical remission at week 8 (last observation carried forward). Results are shown for final intent-to-treat (ITT) and per protocol (PP) populations (explorative analyses).
See this image and copyright information in PMC

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