Biomarker Levels in Patients With Crohn’s Disease Post-Advanced Therapy Induction: A Real-World Survey in Europe
Author(s)
Daniel Wirth, PharmD1, Hannah Knight, MSc2, Sophie Barlow, MSc2, Alexa Russnak, MRes2, Ottavio Secchi, PharmD3.
1Johnson and Johnson, Neuss, Germany, 2Adelphi Real World, Bollington, United Kingdom, 3Johnson and Johnson, Milan, Italy.
1Johnson and Johnson, Neuss, Germany, 2Adelphi Real World, Bollington, United Kingdom, 3Johnson and Johnson, Milan, Italy.
OBJECTIVES: In Crohn’s disease (CD) management, there is limited understanding of the correlation between clinical response to advanced therapy (AT) induction and biomarker levels. We aimed to evaluate C-reactive protein (CRP) and faecal calprotectin (FCP) levels post-AT induction and compare disease activity in patients with elevated vs non-elevated biomarkers.
METHODS: Data were drawn from the Adelphi Real World CD Disease Specific Programme™, a cross-sectional survey of gastroenterologists and their patients with CD in France, Spain, Germany, Italy and the United Kingdom (March-October 2024). Gastroenterologists reported demographics, treatment history and clinical presentation for patients receiving AT post-induction for <52 weeks. Bivariate analyses compared patients with elevated (CRP >5mg/L; FCP >120μg/g) versus non-elevated (CRP ≤5mg/L; FCP ≤120μg/g) biomarkers.
RESULTS: Overall, 116 patients were included, with mean (standard deviation) age 40.5 (13.9) years, and 58% were male. Median (interquartile range; IQR) AT duration was 35.7 (25.0-43.3) weeks. At AT initiation, 70% (n=64) and 73% (n=60) of patients with known biomarker levels (CRP n=92, FCP n=82) had elevated CRP and FCP, respectively. At most recent CRP test (n=89, median [IQR] 20.6 [5.9-26.9] weeks post-AT initiation) and FCP test (n=85, 18.6 [4.4-26.3] weeks), 27% (n=24) and 31% (n=26) had elevated CRP and FCP, respectively. Patients with elevated CRP had worse disease severity, lower remission rates, greater prevalence and worse severity of fatigue, and higher flare rates than patients with non-elevated CRP (all p<0.05). Patients with elevated FCP had worse disease severity, higher Harvey-Bradshaw Index scores and greater prevalence of non-bloody diarrhea than patients with non-elevated FCP (all p<0.05).
CONCLUSIONS: Approximately one-third of patients with CD had elevated biomarkers post-AT induction. Elevated biomarkers were associated with greater disease burden, supporting their use as indicators of disease activity and tools to support clinical judgement regarding treatment decisions. These findings underscore the value of lowering CRP/FCP levels to improve efficacy outcomes.
METHODS: Data were drawn from the Adelphi Real World CD Disease Specific Programme™, a cross-sectional survey of gastroenterologists and their patients with CD in France, Spain, Germany, Italy and the United Kingdom (March-October 2024). Gastroenterologists reported demographics, treatment history and clinical presentation for patients receiving AT post-induction for <52 weeks. Bivariate analyses compared patients with elevated (CRP >5mg/L; FCP >120μg/g) versus non-elevated (CRP ≤5mg/L; FCP ≤120μg/g) biomarkers.
RESULTS: Overall, 116 patients were included, with mean (standard deviation) age 40.5 (13.9) years, and 58% were male. Median (interquartile range; IQR) AT duration was 35.7 (25.0-43.3) weeks. At AT initiation, 70% (n=64) and 73% (n=60) of patients with known biomarker levels (CRP n=92, FCP n=82) had elevated CRP and FCP, respectively. At most recent CRP test (n=89, median [IQR] 20.6 [5.9-26.9] weeks post-AT initiation) and FCP test (n=85, 18.6 [4.4-26.3] weeks), 27% (n=24) and 31% (n=26) had elevated CRP and FCP, respectively. Patients with elevated CRP had worse disease severity, lower remission rates, greater prevalence and worse severity of fatigue, and higher flare rates than patients with non-elevated CRP (all p<0.05). Patients with elevated FCP had worse disease severity, higher Harvey-Bradshaw Index scores and greater prevalence of non-bloody diarrhea than patients with non-elevated FCP (all p<0.05).
CONCLUSIONS: Approximately one-third of patients with CD had elevated biomarkers post-AT induction. Elevated biomarkers were associated with greater disease burden, supporting their use as indicators of disease activity and tools to support clinical judgement regarding treatment decisions. These findings underscore the value of lowering CRP/FCP levels to improve efficacy outcomes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO29
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes
Disease
Gastrointestinal Disorders