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- Title
Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis.
- Authors
D'Haens, G. R.; Sandborn, W. J.; Zou, G.; Stitt, L. W.; Rutgeerts, P. J.; Gilgen, D.; Jairath, V.; Hindryckx, P.; Shackelton, L. M.; Vandervoort, M. K.; Parker, C. E.; Muller, C.; Pai, R. K.; Levchenko, O.; Marakhouski, Y.; Horynski, M.; Mikhailova, E.; Kharchenko, N.; Pimanov, S.; Feagan, B. G.
- Abstract
Background High concentration mesalazine formulations are more convenient than conventional low concentration formulations for the treatment of ulcerative colitis ( UC). Aim To compare the efficacy and safety of 1600 mg and 400 mg tablet mesalazine formulations. Methods Patients with mild-to-moderate active UC (Mayo Clinic Score >5; N=817) were randomised to 3.2 g of oral mesalazine, administered as two 1600 mg tablets once, or four 400 mg tablets twice daily. We hypothesised that treatment with the 1600 mg tablet was non-inferior (within a 10% margin) to the 400 mg tablet for induction of clinical and endoscopic remission at week 8. Open-label treatment with the 1600 mg tablet continued for 26-30 weeks based on induction response. Predictors of treatment response were also explored. Results At week 8, remission occurred in 22.4% and 24.6% of patients receiving the 1600 mg and 400 mg tablets, respectively (absolute difference −2.2%, 95% CI: −8.1% to 3.8%, non-inferiority P=.005). Endoscopic and histopathologic disease activity, leucocyte concentration and age were significantly associated with clinical remission ( P=.022, .042, .014 and .023, respectively). At week 38, 43.9% (296/675) of patients who continued treatment with the 1600 mg formulation were in remission, including 70.3% (142/202) of patients who received a reduced dose of mesalazine (1.6 g/d). The overall incidence of serious adverse events was low. Conclusions Induction therapy with 3.2 mg mesalazine using two 1600 mg tablets once-daily was statistically and clinically non-inferior to a twice-daily regimen using four 400 mg tablets ( NCT01903252).
- Subjects
COLITIS treatment; ULCERATIVE colitis; MESALAMINE; DRUG efficacy; HISTOPATHOLOGY; PATIENTS; THERAPEUTICS
- Publication
Alimentary Pharmacology & Therapeutics, 2017, Vol 46, Issue 3, p292
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.14164