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Introduction <p>The LIBERTY-CD study demonstrated superior efficacy of subcutaneous infliximab-dyyb over placebo for maintenance therapy in patients with Crohn’s disease. This post hoc analysis characterised subgroups of patients with different response levels to subcutaneous infliximab.</p> Methods <p>Group-based trajectory modelling was conducted to deconvolute cohort-level data into individual response trajectories based on longitudinal patient-reported outcomes. Potential predictors of subcutaneous infliximab response were explored using multivariable analyses. Subgroups were compared for clinical, endoscopic, biochemical, and health-related quality of life outcomes; comprehensive disease control (achieving composite endpoints) at week&#xa0;54; pre-dose serum infliximab levels; and safety.</p> Results <p>Four distinct subgroups of patients were identified: super-responders (rapid and high sustained improvement); fast responders; slow responders; and limited responders (partial improvement). In multivariable analyses, lower baseline body mass index (<i>p</i> = 0.022) and pre-dose serum infliximab levels ≥ 14&#xa0;μg/ml at week&#xa0;10 (<i>p</i> = 0.003) were associated with a super-response. At week&#xa0;54, super-responders showed the highest rates of clinical remission (80.3%; <i>p</i> = 0.002), endoscopic response (63.9%; <i>p</i> = 0.009), health-related quality of life remission (72.1%; <i>p</i> = 0.0002), corticosteroid-free remission (59.1%; <i>p</i> = 0.007), and comprehensive disease control achievement (27.9%; <i>p</i> = 0.014) versus other trajectories. Among groups, super-responders maintained the highest pre-dose serum infliximab levels from week&#xa0;10. Comparable overall safety profiles were observed across groups.</p> Conclusion <p>Distinct subpopulations with varying responses to infliximab were identified by group-based trajectory modelling using longitudinal symptom data, which may support the development of personalised therapy. Super-responders with rapid and sustained improvements during infliximab therapy were more likely to achieve desirable long-term outcomes.</p> Trial Registration <p>ClinicalTrials. gov identifier, NCT03945019 (08 May&#xa0;2019).</p>

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Symptom Response Dynamics for Personalised Therapy with Subcutaneous Infliximab in Crohn’s Disease: Insights from the Randomised, Placebo-Controlled, Phase 3 LIBERTY-CD Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月30日

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  • Stefan Schreiber,
  • Bruce E. Sands,
  • Silvio Danese,
  • Edward V. Loftus Jr.,
  • Ae Lee Jeong,
  • Dong-Hyeon Kim,
  • Young Nam Lee,
  • Jean-Frédéric Colombel

摘要

Introduction

The LIBERTY-CD study demonstrated superior efficacy of subcutaneous infliximab-dyyb over placebo for maintenance therapy in patients with Crohn’s disease. This post hoc analysis characterised subgroups of patients with different response levels to subcutaneous infliximab.

Methods

Group-based trajectory modelling was conducted to deconvolute cohort-level data into individual response trajectories based on longitudinal patient-reported outcomes. Potential predictors of subcutaneous infliximab response were explored using multivariable analyses. Subgroups were compared for clinical, endoscopic, biochemical, and health-related quality of life outcomes; comprehensive disease control (achieving composite endpoints) at week 54; pre-dose serum infliximab levels; and safety.

Results

Four distinct subgroups of patients were identified: super-responders (rapid and high sustained improvement); fast responders; slow responders; and limited responders (partial improvement). In multivariable analyses, lower baseline body mass index (p = 0.022) and pre-dose serum infliximab levels ≥ 14 μg/ml at week 10 (p = 0.003) were associated with a super-response. At week 54, super-responders showed the highest rates of clinical remission (80.3%; p = 0.002), endoscopic response (63.9%; p = 0.009), health-related quality of life remission (72.1%; p = 0.0002), corticosteroid-free remission (59.1%; p = 0.007), and comprehensive disease control achievement (27.9%; p = 0.014) versus other trajectories. Among groups, super-responders maintained the highest pre-dose serum infliximab levels from week 10. Comparable overall safety profiles were observed across groups.

Conclusion

Distinct subpopulations with varying responses to infliximab were identified by group-based trajectory modelling using longitudinal symptom data, which may support the development of personalised therapy. Super-responders with rapid and sustained improvements during infliximab therapy were more likely to achieve desirable long-term outcomes.

Trial Registration

ClinicalTrials. gov identifier, NCT03945019 (08 May 2019).