P349. The effect of ulcerative colitis (UC) remission status after 8 weeks of induction therapy with MMX® mesalazine on long-term maintenance therapy outcomes (MOMENTUM Study): induction phase results
G. D'Haens1, D.T. Rubin2, S. Inglis3, E. Magee4, P. Streck4, D. Solomon4, on behalf of the Ulcerative Colitis Remission Study Group, 1Academic Medical Center, Amsterdam, Netherlands, 2University of Chicago Inflammatory Bowel Disease Center, Chicago, IL, United States, 3Shire Pharmaceutical Development Ltd, Basingstoke, United Kingdom, 4Shire Development LLC, Wayne, PA, United States
Oral 5-aminosalicylic acid formulations are recommended first-line therapy for mild-to-moderate active UC. However, data are lacking for long-term outcomes with maintenance therapy following induction.
This ongoing open-label, prospective study will evaluate outcomes at 12 months in UC patients (pts) achieving complete (clinical and endoscopic) or partial remission after 8 weeks of induction therapy with MMX® mesalazine (NCT01124149; Shire Development LLC). Adults with active mild-to-moderate UC (acute flare or newly diagnosed with modified UC Disease Activity Index [UC-DAI] total score 4–10, endoscopy score ≥1, and Physician's Global Assessment ≤2) receive 8 weeks of MMX mesalazine 4.8 g/d QD during induction. Pts achieving complete (modified UC-DAI ≤1; rectal bleeding and stool frequency scores = 0; ≥1-point reduction in endoscopy score) or partial (modified UC-DAI ≤3 combined stool frequency and rectal bleeding score ≤1 not in complete remission) remission at Week 8 will receive maintenance MMX mesalazine 2.4 g/d QD for 12 months. The primary endpoint is complete remission after 12 months of maintenance. Here we report results from the 8-week induction phase.
Of 672 pts included in this preplanned interim data cut, 666 are included in the efficacy/safety population; 610 completed the induction phase and 467 entered the maintenance phase. A mean (SD) of 40.1 (185.25) days had passed since the last acute episode, and 664 (99.7%) pts had histology compatible with UC. At Week 3, symptom improvement (≥1-point reduction from baseline) was observed in 43.1%, 38.9%, and 26.3% of pts for rectal bleeding, stool frequency, or both, respectively, and increased to 63.4%, 62.2%, and 48.0%, respectively, at Week 8. Complete or partial remission was achieved by 27.9% and 42.2% of pts, and 33.3% of pts achieved normal endoscopy (subscore = 0). Mean (SD) UC-DAI score decreased by 4.3 (2.24) points after 8 weeks of induction therapy. The most common treatment-emergent adverse events during the induction phase were lack of efficacy (6.5%), fever (1.8%), and headache (1.8%).
After 8 weeks of MMX mesalazine induction therapy, >60% of pts in this data cut had improvement in rectal bleeding or stool frequency, and about half had improvement in both; 70% achieved complete or partial remission, and one-third had normal endoscopy. There were no new safety signals identified. Results of the maintenance phase will be reported after study completion.