The analyses of Lialda’s 303 trial, a long-term, Phase III, open-label 12-14 month extension study, will be presented at the American College of Gastroenterology meeting in Philadelphia. A post-hoc analysis of secondary endpoints from the long-term 303 study was performed to review the efficacy of Lialda for maintaining remission in patients with mild versus moderate ulcerative colitis.
In the 303 study, patients were randomized to receive Lialda 2.4g/day (given once daily) or 2.4g/day (1.2g given twice daily). Of the 451 patients included in the analysis, this post-hoc analysis showed that 70.5% (117/166) of patients with mild ulcerative colitis and 64.2% (183/285) of patients with moderate ulcerative colitis were in remission at 12 months.
A different post-hoc analysis of secondary endpoints from study 303 was done to understand the effect of relapse history in patients with mild-to-moderate ulcerative colitis on the efficacy of maintenance therapy. Of patients who previously experienced less than three relapses in the two years prior to parent study baseline, the analysis showed 70.1% (192/274) achieved remission at 12 months. In comparison, 59.8% (98/164) of patients who previously experienced greater than or equal to 3 relapses in the two years prior to parent study baseline achieved remission at 12 months.
Gary Lichtenstein, director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania, said: “Earlier studies showed that Lialda is well-tolerated and effective at inducing remission in patients with active, mild to moderate UC. Post-hoc analysis of secondary endpoints provided evidence that Lialda maintained remission in a variety of UC patients.”