The Effect of Ulcerative Colitis (UC) Remission Status After Induction With MMX® Mesalamine on Long-Term Maintenance Therapy Outcomes (MOMENTUM Study): Induction Phase Results Presidential Poster

Abstract

Purpose: 5-aminosalicylic acid therapy is the mainstay of treatment for mildly-to-moderately active UC. However, data are lacking for long-term outcomes with maintenance therapy and transitions from induction phase to maintenance phase. Methods: This is an open-label, prospective study evaluating 12-month results in UC patients who achieved complete (clinical and endoscopic) or partial remission after 8 weeks of induction therapy with MMX® mesalamine (NCT01124149). 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) received 8 weeks of MMX mesalamine 4.8 g/d QD during acute treatment. Those patients who achieved complete remission (modified UC-DAI ≤1; rectal bleeding and stool frequency scores of 0; ≥1-point reduction in endoscopy score) or partial remission (modified UC-DAI ≤3; combined stool frequency and rectal bleeding score ≤1; not in complete remission) at Week 8 continue to receive maintenance MMX mesalamine 2.4 g/d QD for 12 months (ongoing portion of the study). The primary endpoint is the percentage of patients in complete remission after 12 months of maintenance. Here we report results from the 8-week induction phase. Results: This pre-determined interim data cut included 672 patients, of whom 666 are included in the efficacy/safety population. The induction phase was completed by 610 patients and 467 entered the maintenance phase; 664 (99.7%) 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 patients for rectal bleeding, stool frequency, or both, respectively; at Week 8, these proportions increased to 63.4%, 62.2%, and 48.0%, respectively. Complete or partial remission was achieved by 27.9% and 42.2% of patients at Week 8, and complete mucosal healing (endoscopic subscore of 0) was achieved by 33.3%. Mean ± SD UC-DAI score decreased by 4.3 ± 2.24 points after the 8-week induction phase. The most common treatment-emergent adverse events during the induction phase were inefficacy of drug (6.5%), headache (1.8%), and fever (1.8%). Conclusion: This is the largest study of MMX mesalamine for mild to moderate UC and the 8 week induction results demonstrated a majority with partial or complete remission, and 33% with normal endoscopy (subscore of 0). There were no new safety signals. Unique to this study design is the enrollment of all patients during a flare with follow-through to maintenance phase (to be reported later). Disclosure: David T. Rubin - Financial Support for Research: Abbott, Elan, Warner Chilcott, Prometheus, Shire Development LLC; Lecture Fee(s): Merck; Consultancy: Abbott, Janssen, UCB, Elan, Shire, Exagen, Prometheus, Takeda. Geert D'Haens - Financial Support for Research: Abbott Laboratories, Jansen Biologics, Given Imaging, MSD, DrFalk Pharma, Photopill, Shire Development LLC; Lecture Fee(s): Abbott Laboratories, Tillotts, Tramedico, Ferring, MSD, UCB, Norgine, Shire; Consultancy: Abbott Laboratories, Actogenix, Centocor, Cosmo, Engene, Ferring Pharmaceuticals, GlaxoSmithKline, Jansen Biologics, Millenium Pharmaceuticals, MSD, Novonordisk, PDL Biopharma, Pfizer, SetPoint, Shire, Takeda, Teva, UCB Susi Inglis. Elizabeth Magee - Employees: Shire Pharmaceutical Development Ltd. Dory Solomon - Employee: Shire Development LLC. This research was supported by an industry grant. This study was funded by Shire Development LLC, Wayne, PA, USA.