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IMPROVED REMISSION RATES FROM ONCE- VERSUS TWICE-DAILY MESALAZINE (PENTASA) GRANULES FOR THE MAINTENANCE OF REMISSION IN ULCERATIVE COLITIS: RESULTS FROM A MULTINATIONAL RANDOMISED CONTROLLED TRIAL
H Veerman1, A Dignass2, SVermeire3, H Adamek4, R Befrits5, B Bokemeyer6, N Börner7, T Klugmann8, M Mross9, T Stijnen10, G Tan11, K Therkelsen12, C Thordal13
1Medical, Ferring BV, Hoofdorp, Netherlands; 2Markus-Krankenhaus, Frankfurt, Germany; 3University Hospital Gasthuisberg, Leuven, Belgium; 4Klinikum Leverkusen, Leverkusen, Germany, 5Karolinska, Stockholm, Sweden; 6Gemeinschaftspraxis, Minden; 7Gemeinschaftspraxis, Mainz; 8Internistische Gemeinschaftspraxis, Leipzig; 9Internistische Praxis, Berlin, Germany; 10Leiden University, Leiden; 11Streekziekenhuis Midden Twente, Hengelo, Netherlands; 12Sygehus Vendyssel, HjØrring; 13Viborg Sygehus, Viborg, Denmark
INTRODUCTION: Patients with quiescent ulcerative colitis (UC) are often non-compliant with prescribed mesalazine treatment. This is, in part, due to the inconvenience of currently available mesalazine formulations, which often require multiple-daily dosing regimens and a high number of tablets. Non-compliance can lead to a disease exacerbation. This study investigated remission and relapse rates in patients with UC in remission receiving once (od) or twice (bid) daily mesalazine granules.
AIMS & METHODS: A 12-month, investigator blinded randomized controlled trial. Patients with mild to moderate UC in remission who had had a relapse within the past year were randomized to receive either mesalazine granules 2g/day given od (1×2g sachet) or bid (2×1g sachets). The primary objective was to demonstrate non-inferiority (defined as not more than 10% less efficacy below the od treatment) of the two regimes in terms of both clinical and endoscopic remission at one year defined by a UCDAI score of <2.
RESULTS: 362 patients were randomised. At end-of-study, 73.8% and 63.6% of patients in the od and bid groups were in clinical and endoscopic remission, respectively. The treatment difference with Kaplan-Meier one year remission rates (in %) was not only above the non-inferiority limit, but od also turned out to be superior with a treatment differences of 11.9 in favour of od (P=0.024). Once daily dosing had a higher compliance than bid dosing in terms of % sachets used. Patient questionnaires yielded higher compliance scores for od than bid (P<0.05). Patient acceptability of treatment was significantly better for od (P<0.001) at end-of-study.
CONCLUSION: Once-daily 2g mesalazine granules (PENTASA) are an effective maintenance therapy in patients suffering from mild to moderate UC. A once daily dosing regime is not only non-inferior but even superior to twice daily dosing. Mesalazine taken once daily (2g) ensures better remission rates, patient compliance and acceptability than twice daily (2×1g) administration.
Research was fully funded by Ferring Pharmaceuticals