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Introduction: High-strength mesalazine formulations play an important role in providing a convenient option to increase the dose in ulcerative colitis (UC) patients and therefore avoiding the switch to another therapeutic class. Higher doses of mesalazine may be required during periods of remission in order to prevent relapse. Aim: To investigate clinical outcomes of three mesalazine maintenance doses adapted for post induction response. Methods: In this post-hoc analysis, 675 UC patients entered an open label extension study for a total of 38 weeks (including 8-12 week induction period with 3.2 g/day mesalazine). After the induction period they were separated into three groups: remitters (in clinical and endoscopic remission), responders (decrease in Partial Mayo Clinic Score (PMCS) of ≥ 2 points and ≥ 30% from week 0) and non-responders (failed to achieve endoscopic and clinical response at week 8) and received 1.6 g/day, 3.2 g/day or 4.8 g/day of mesalazine (using a new 1600 mg mesalazine tablet), respectively. Results: 133/202 (65.8%), 108/274 (39.4%) and 59/199 (29.6%) patients achieved clinical and endoscopic remission at week 38 with 1.6 g/day, 3.2 g/day and 4.8 g/day, respectively. At week 38, 142/202 (70.3%), 93/274 (33.9%) and 61/199 (30.7%) patients achieved clinical remission (stool score of 0 and rectal bleeding score of 0) with 1.6 g/day, 3.2 g/day and 4.8 g/day, respectively. Conclusions: Patients partially responding or not responding to an initial induction dose of 3.2 g/day mesalazine could benefit from an extended treatment period at the same dose, or an increase to 4.8 g/day in an attempt to achieve combined clinical and endoscopic remission.

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Although ulcerative colitis (UC) shares many common pathways and therapeutic options with Crohn’s disease (CD), CD patients are four times more likely to undergo surgery 10 years into their disease in biologic era and are more likely to have extraintestinal manifestations than UC patients. Early treatment in CD has been demonstrated to modify natural history of disease and potentially delay surgery. Previous reviews on this topic borrowed their evidence from CD to make UC-specific recommendations. This review highlights the emergence of UC-specific data from larger cohort studies and a comprehensive individual patient data systemic review and meta-analysis to critically appraise the evidence on utility of early escalation to advanced therapies with respect to short-, medium-, and long-term outcomes. In UC, the utility of the early escalation concept for the purposes of changing the natural history, including reducing colectomy and hospitalisations, is not supported by the available data. Data on targeting clinical, biochemical, endoscopic, and histological outcomes are needed to demonstrate that they are meaningful with regards to achieving reductions in hospitalization and surgery, improving quality of life, and minimizing disability. The analyses of different populations of UC patients, such as those with "relapsing & remitting" disease or with severe or complicated disease course, are urgently needed. The costs and risk/benefit profile of some of the newer advanced therapies should be carefully considered. In this clinical landscape, it appears premature to advocate an indiscriminate ‘one size fits all’ approach to escalating to advanced therapies early during the course of UC.

Background Ulcerative colitis (UC) incidence has bimodal age distribution with a peak in the second to fourth decade and a second smaller peak in the sixth to eighth decade. We assessed the difference in rates of clinical and endoscopic response and remission in adult (≤60 years of age) and elderly (>60 years of age) mild-to-moderate (Mayo Clinic Score ≥5) UC patients treated with mesalazine. Methods We performed a post-hoc analysis of data from a phase 3 non-inferiority trial of 817 UC patients treated with mesalazine for 8 and additional 38 weeks in a double-blind and open label study, respectively (D’Haens et al. Aliment Pharmacol Ther.2017;46:292–302). The differences between groups were analysed using Wilcoxon rank sum or chi-square test with continuity correction. P-value of <0.05 was considered to be statistically significant. Results Elderly patients had longer disease duration, higher body mass index, higher number of co-morbiditities and concomitant medications recorded prior and during the trial, when compared with adults participating in the study (Table 1). These patients also had higher baseline Mayo endoscopic score (2.38±0.486 standard deviation [SD] in elderly vs. 2.26±0.439 SD in adult patients; p-value=0.0077). No difference in rates of combined clinical and endoscopic remission, clinical remission and response, endoscopic remission and response were observed at week 8 and 38 (Table 2). Conclusion We observed similar rates of clinical and endoscopic response and remission in adult and elderly mild-to-moderate UC patients treated with mesalazine for 8 and 38 weeks.