Mesalazine 1,600-mg formulation noninferior to 400 mg for induction treatment of UC
In patients with ulcerative colitis (UC), induction treatment with 3.2 mg mesalazine using two 1,600 mg tablets once-daily is as good as using four 400 mg tablets twice-daily, according to the results of a noninferority trial.
A total of 817 patients with mild-to-moderate active UC (Mayo Clinic Score >5) were treated with 3.2 g of oral mesalazine, administered as either two 1,600 mg tablets once or four 400 mg tablets twice daily. Outcomes investigated were induction of clinical and endoscopic remission at week 8. Based on response, open-label treatment with the 1,600 mg tablet continued for 26 to 30 weeks. Predictors of treatment response were also examined.
At week 8, remission occurred in 22.4 percent of patients receiving the 1,600 mg formulation and in 24.6 percent of those receiving the 400 mg formulation (absolute difference, −2.2 percent; 95 percent CI, −8.1 to 3.8; noninferiority, p=0.005). Clinical remission was significantly associated with endoscopic and histopathologic disease activity (p=0.022 and p=0.042), leucocyte concentration (p=0.014), and age (p=0.023).
At week 38, 296 of 675 patients (43.9 percent) who continued treatment with the 1,600 mg formulation were in remission, including 142 of 202 patients (70.3 percent) who received a reduced dose of mesalazine (1.6 g/d). Overall incidence of serious adverse events was low.
Oral mesalazine is the most commonly prescribed medication for patients with mild-to-moderate UC. While multitablet regimens administered two to four times daily have been shown to be safe and effective, a high-concentration formulation was developed to improve dosing convenience and ensure consistent drug release within the colon. [Gastroenterology 2015;148:1035-1058; Cochrane Database Syst Rev 2016;4:CD000543]