UC-INCREASE: multicentre observational study evaluating the effectiveness of different mesalazine doses and formulations in patients with ulcerative colitis in daily clinical practice
Department of Gastroenterology and Internal Medicine, National Medical Institute of the Ministry of the Interior and Administration, Warsaw, Poland
Department of Gastroenterology, Dietetics, and Internal Medicine, University Clinical Hospital, Poznan, Poland
Department of Gastroenterology, Dietetics, and Internal Medicine, Poznan University of Medical Sciences, Poznan University Clinical Hospital, Poznan, Poland
Department of Digestive Tract Diseases, Medical University of Lodz, Poland
Collegium Medicum, Jan Kochanowski University, Kielce, Poland
IBD Clinical and Research Centre, ISCARE a.s., Prague, Czech Republic
Introduction
Mesalazine remains a first-line therapy for mild-to-moderate ulcerative colitis (UC), but optimal dosing, combined oral–rectal treatment, and formulation selection remain uncertain.
Aim
To evaluate outcomes after mesalazine optimisation and compare oral doses within left-sided colitis (E2) and extensive colitis (E3) as well as oral formulations.
Material and methods
UC-INCREASE retrospectively included 243 adults: 152 with E2 receiving oral mesalazine plus a rectal enema and 91 with E3 receiving oral mesalazine alone. Oral doses of 3 versus 4 g/day were compared within E2 and E3; prolonged-release granules were compared with other tablets. Endpoints included component-verified clinical remission based on Partial Mayo Score (PMS) ≤ 2 or Total Mayo Score (TMS) ≤ 2, endoscopic Mayo subscore (eMayo) = 0, and faecal calprotectin (FC) < 250 µg/g. Comparisons used unadjusted odds ratios (ORs).
Results
Median C-reactive protein decreased from 16.8 to 4.5 mg/l, FC from 516 to 111 µg/g, TMS from 6 to 2, and PMS from 5 to 1 (all p < 0.001). PMS-defined, TMS-defined, endoscopic, and biochemical remission occurred in 86%, 57%, 24%, and 81%, respectively. Within E2, endoscopic remission was more frequent with 4 versus 3 g/day plus rectal mesalazine (45% vs. 8%; OR = 8.89, 95% CI: 3.26–24.25; p < 0.001). Within E3, no endpoint differed significantly between doses. Prolonged-release granules were associated with improvement of all endpoints and fewer recorded adverse events (26% vs. 62%; OR = 0.21).
Conclusions
Mesalazine optimisation was associated with broad improvement. Comparative findings were exploratory and require prospective confirmation.
Keywords
ulcerative colitis, mesalamine, aminosalicylic acids, administration, rectal, dosage forms
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