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Once-daily mesalazine as safe, effective as twice-daily dose for ulcerative colitis
Patients with mild-to-moderate ulcerative colitis treated with once-daily mesalazine experienced similar outcomes to those receiving twice-daily doses in a recent study.
In a phase 3b, controlled, multicenter trial, researchers randomly assigned 206 patients with mild-to-moderate ulcerative colitis (UC) to receive 4 g mesalazine daily for 8 weeks. Administration was either once (n=102, OD), with two 2 g capsules in the morning, or twice (n=104, BD), with one 2 g capsule in the morning and one at night. All participants also received a 1 g mesalazine enema daily for the first 4 weeks. Disease activity was measured according to the UC Disease Activity Index (UC-DAI) upon randomization and at 8 weeks.
The intention-to-treat population included 101 OD and 101 BD recipients; the per-protocol population included 79 OD and 77 BD recipients. In the ITT population, OD (52.1%) and BD (41.8%) patients experienced similar clinical and endoscopic remission, defined as UC-DAI score of 1 or less (P=.14). Complete remission (a UC-DAI score of 0) occurred similarly in the OD (35.5%) and BD (29.2%) groups (P=.37).
More patients had improved UC-DAI scores (92% of cases vs. 79%; P=.01) and more experienced mucosal healing (87.5% vs. 71.1%; P=.007) in the OD group. Time to remission also was shorter among OD recipients (26 days vs. 28 days; P=.04).
Treatment compliance, acceptability and incidence of at least one adverse event (34.3% of OD recipients vs. 38% of BD recipients) were similar between groups. Treatment-emergent events were mild-to-moderate in severity and occurred in 32.4% of OD and 34% of BD cases. Five patients experienced severe events.
“The OD oral dose of prolonged-release mesalazine is an effective and easy to use treatment for patients with mild-to-moderate active UC,” the researchers concluded. “It was also shown that OD dosing may offer benefits as well as being more convenient for patients as clinical and endoscopic improvement was higher, time to remission was shorter and mucosal healing was increased compared with BD dosing.”
Disclosure: See the study for a full list of relevant disclosures.