How close are we to a success stratification tool for improving biological therapy in ulcerative colitis?

ABSTRACT

Introduction

Biological therapies have become the standard treatment for ulcerative colitis (UC). However, clinical remission rates post-induction therapy remain modest at 40–50%, with many initial responders losing response over time. Current treatment strategies frequently rely on a ‘trial and error’ approach, leading to prolonged periods of ineffective and costly therapies for patients, accompanied by associated treatment complications.

Area covered

This review discusses current evidence on risk stratification tools for predicting therapeutic efficacy and minimizing adverse events in UC management. Recent studies have identified predictive factors for biologic therapy response. In the context of personalized medicine, the goal is to identify patients at high risk of progression and complications, as well as those likely to respond to specific therapies. Essential risk stratification tools include clinical decision-making aids, biomarkers, genomics, multi-omics factors, endoscopic, imaging, and histological assessments.

Expert opinion

Employing risk stratification tools to predict therapeutic response and prevent treatment-related complications is essential for precision medicine in the biological management of UC. These tools are necessary to select the most suitable treatment for each individual patient, thereby enhancing efficacy and safety.

KEYWORDS:

• Ulcerative colitis; biologic
• predictor
• risk stratification
• response
• personalized medicine

Article highlights

• Biologics are standard treatments for moderate to severe ulcerative colitis (UC). Many patients achieve only modest remission and may lose response over time, underscoring the need for stratification tools to identify the best biologic for each patient and balance treatment risks and benefits.

• Clinical decision support tools (CDSTs) and biomarkers like CRP, fecal calprotectin, and serum albumin are essential for predicting biologic therapy response and monitoring disease activity. These tools help identify non-responders early and adjust treatment strategies.

• Endoscopic mucosal healing and histological remission are key in UC management, linked to better long-term outcomes. Monitoring these parameters helps adjust biologic therapies for deeper disease control and improved prognosis.

• Advances in genomics and multiomics, such as transcriptomics and single-cell RNA sequencing, offer promise for personalized UC treatment by identifying specific gene expressions and genetic predictors. However, clinical implementation is still limited.

• Risk stratification for safety is crucial when selecting biologics, especially in older patients or those with comorbidities. Vedolizumab and ustekinumab have shown lower infection-related hospitalization rates compared to anti-TNF treatments, particularly in high-risk groups.

Declaration of interest

P Wetwittayakhlang has been a speaker for Takeda, Pfizer, Janssen, Ferring, A. Menarini, and MSD, and an advisory board member for Pfizer, Takeda, and Sandoz (Novartis). T Bessissow has been a speaker for Takeda, Janssen, AbbVie, Merck, Pfizer, Pendopharm, Ferring, Shire, Sandoz, BMS, Roche. PL Lakatos has been a speaker and/or advisory board member: AbbVie, Amgen, BioJamp, Bristol Myers Squibb, Fresenius Kabi, Genentech, Gilead, Janssen, Merck, Mylan, Organon, Pendopharm, Pfizer, Roche, Sandoz, Takeda, Tillots and Viatris and has received unrestricted research grant: AbbVie, Gilead, Takeda and Pfizer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

P Wetwittayakhlang: conception, performed the literature review, wrote the draft of the manuscript. PL Lakatos: conception, performed the literature review, wrote and supervised the manuscript. G Kotrri: conception, literature review. T Bessissow: revised manuscript. All authors reviewed and approved the last version of this manuscript.

Additional information

Funding

This paper was not funded.