P0667 Therapeutic Optimization of Biologic Therapy in Ulcerative Colitis: A Retrospective Analysis of Endoscopic and Biomarker Outcomes
Authors: Bezzio C , Bertin L , Ranucci L G , Marconcini G , Busacca A , Dal Buono A , Gabbiadini R , Loy L , Privitera G , Armuzzi A 
Published: January 2025

Background

Biologic therapies have transformed the management of ulcerative colitis (UC), offering effective options for achieving remission. However, some patients require therapy optimization, guided by clinical and endoscopic assessments, to enhance outcomes. Despite their routine use, real-world comparisons of optimization strategies for different biologics remain limited. This study evaluates the impact of endoscopy-guided optimization on remission rates and safety profiles in a UC cohort.

Methods

This retrospective study included consecutive patients at the Humanitas outpatient clinic from 2021 to 2023 who underwent endoscopy-guided therapy optimization. All patients had minimal clinical activity (pMayo score &lt;2) and underwent colonoscopy to assess biologic therapy response. Statistical analyses included the Student’s t-test or Mann-Whitney U test for continuous variables, and chi-square or Fisher’s exact test for categorical variables. Propensity score matching (PSM) was used to balance baseline characteristics, including bio-experienced status.

Results

A cohort of 176 UC patients was included. Among them, therapy optimization with anti-TNFs was used in 41.2% for infliximab, 19.9% for adalimumab, and 4.6% for golimumab, while 14.4% received ustekinumab and 17.1% vedolizumab. Multivariate logistic regression analysis identified key predictors for outcomes: patients who were biologic-experienced at baseline had significantly reduced odds of achieving endoscopic remission at 12 months following optimization (odds ratio [OR] = 0.223, 95% CI: 0.070–0.711, p = 0.011). Other variables, including age at diagnosis, disease extent, and specific biologic therapy (anti-TNF vs. ustekinumab vs. vedolizumab), were not statistically significant predictors of remission.

In the PSM-adjusted dataset, endoscopic remission rates were 61.5% for anti-TNFs, 33.3% for ustekinumab, and 60.0% for vedolizumab (p = 0.666, chi-square test). Biochemical remission was also highest in the anti-TNF group (61.8%), significantly greater than in ustekinumab (26.7%) and vedolizumab (53.3%) (p = 0.042, chi-square test). Adverse events were least frequent in the ustekinumab and vedolizumab groups, with only 3.5% reported for anti-TNFs (p = 0.293, Fisher’s exact test).

Adverse events remained low across all groups, with a tendency toward fewer events in the ustekinumab and vedolizumab groups compared to anti-TNFs, though these differences were not statistically significant (p = 0.324, Fisher’s exact test).

Conclusion

The optimization of Anti-TNFs showed superior endoscopic healing and biomarker remission rates compared to ustekinumab and vedolizumab, with all groups exhibiting low adverse event rates.

References

1.Turner D, Ricciuto A, Lewis A, D’Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Schölmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19. PMID: 33359090.

2.Shah SC, Colombel JF, Sands BE, Narula N. Mucosal Healing Is Associated With Improved Long-term Outcomes of Patients With Ulcerative Colitis: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1245-1255.e8. doi: 10.1016/j.cgh.2016.01.015. Epub 2016 Jan 30. PMID: 26829025.