A once-daily dose of MMX mesalamine may be noninferior to a twice-daily dose of delayed-release mesalamine for maintaining endoscopic remission in patients with ulcerative colitis, according to a recent study.
In a multicenter, randomized, double blind trial, 826 patients with ulcerative colitis (UC) in endoscopic remission received either 2.4 g MMX mesalamine (Lialda, Shire) once daily (n=415) or 0.8 g delayed-release mesalamine (Asacol, Warner Chilcott) twice daily (n=411) for 6 months. Of these patients, 343 in the MMX group and 336 in the delayed-release group were included in the per-protocol (PP) population, with 147 patients excluded because of protocol deviations, most commonly stopping treatment for a lack of efficacy.
Among patients who received MMX mesalamine, 83.7% of patients in the PP population maintained endoscopic remission, compared with 81.5% of the PP population in the twice-daily group (95% CI, –3.9%, 8.1%). Patients in the intent-to-treat (ITT) population maintained remission in 77.8% of MMX cases, compared with 76.9% of the ITT population in the twice-daily group (95% CI, –5.0%, 6.9%). Mild or no symptoms were observed in 79.0% of the MMX group PP population, compared with 75.6% in the delayed-release group (95% CI, –3.2%, 10.0%)
The two groups also experienced similar times to relapse, with 12.8% of patients in the MMX group PP population withdrawing from the study because of relapse compared with 14.6% in the delayed-release group (HR=0.87; log-rank test, P=.5116). Adverse events were experienced by 37.1% of patients in the MMX ITT group, compared with 36.0% in the delayed-release group, and included UC, dyspepsia, headache and fatigue. No serious events were considered related to the treatment.
“Once-daily dosing of MMX mesalamine at a dose of 2.4 g/day was shown to be noninferior [equivalent] to twice-daily dosing of 0.8 g/day delayed-release mesalamine … for the maintenance of endoscopic remission in patients with UC,” the researchers concluded.