Biomarker Levels in Patients With Ulcerative Colitis Post-Advanced Therapy Induction: A Real-World Survey in Europe
Author(s)
Ottavio Secchi, PharmD1, Hannah Knight, MSc2, Sophie Barlow, MSc2, Alexa Russnak, MRes2, Daniel Wirth, PharmD3.
1Johnson and Johnson, Milan, Italy, 2Adelphi Real World, Bollington, United Kingdom, 3Johnson and Johnson, Neuss, Germany.
1Johnson and Johnson, Milan, Italy, 2Adelphi Real World, Bollington, United Kingdom, 3Johnson and Johnson, Neuss, Germany.
OBJECTIVES: Little is known regarding the correlation between real-world response to advanced therapy (AT) induction and biomarkers in patients with ulcerative colitis (UC). We aimed to evaluate biomarker levels post-AT induction and compare disease activity between patients with elevated vs non-elevated C-reactive protein (CRP) and faecal calprotectin (FCP).
METHODS: Data were drawn from the Adelphi Real World UC Disease Specific Programme™, a cross-sectional survey of gastroenterologists and their patients with UC 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) and non-elevated (CRP ≤5mg/L; FCP ≤120μg/g) biomarkers.
RESULTS: Overall, 123 patients were included, with mean (standard deviation) age 41.3 (14.0) years, and 56% were male. Median (interquartile range; IQR) treatment duration was 34.3 (23.9-44.3) weeks. At AT initiation, 66% (n=64) and 78% (n=80) of patients with known biomarker levels (CRP n=97, FCP n=103) had elevated CRP and FCP, respectively. At most recent CRP test (n=98, median [IQR] 17.1 [7.7-28.3] weeks post-AT initiation) and FCP test (n=104, 16.6 [0.8-28.2] weeks), 18% (n=18) and 27% (n=28) of patients had elevated CRP and FCP, respectively. Patients with elevated CRP had worse disease severity, higher flare rates, higher Mayo scores, lower remission rates, greater prevalence of fatigue and were less likely to be asymptomatic than patients with non-elevated CRP (all p<0.05). Patients with elevated FCP had worse disease severity, greater prevalence of bowel urgency, lower endoscopic remission rates and higher Mayo scores than patients with non-elevated FCP (all p<0.05).
CONCLUSIONS: Elevated biomarkers post-AT induction were correlated with worsened disease activity, reinforcing their clinical value in supporting treatment strategies. There is need for alternative treatments that achieve normalized biomarker levels to enhance efficacy outcomes.
METHODS: Data were drawn from the Adelphi Real World UC Disease Specific Programme™, a cross-sectional survey of gastroenterologists and their patients with UC 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) and non-elevated (CRP ≤5mg/L; FCP ≤120μg/g) biomarkers.
RESULTS: Overall, 123 patients were included, with mean (standard deviation) age 41.3 (14.0) years, and 56% were male. Median (interquartile range; IQR) treatment duration was 34.3 (23.9-44.3) weeks. At AT initiation, 66% (n=64) and 78% (n=80) of patients with known biomarker levels (CRP n=97, FCP n=103) had elevated CRP and FCP, respectively. At most recent CRP test (n=98, median [IQR] 17.1 [7.7-28.3] weeks post-AT initiation) and FCP test (n=104, 16.6 [0.8-28.2] weeks), 18% (n=18) and 27% (n=28) of patients had elevated CRP and FCP, respectively. Patients with elevated CRP had worse disease severity, higher flare rates, higher Mayo scores, lower remission rates, greater prevalence of fatigue and were less likely to be asymptomatic than patients with non-elevated CRP (all p<0.05). Patients with elevated FCP had worse disease severity, greater prevalence of bowel urgency, lower endoscopic remission rates and higher Mayo scores than patients with non-elevated FCP (all p<0.05).
CONCLUSIONS: Elevated biomarkers post-AT induction were correlated with worsened disease activity, reinforcing their clinical value in supporting treatment strategies. There is need for alternative treatments that achieve normalized biomarker levels to enhance efficacy outcomes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO30
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Clinician Reported Outcomes
Disease
Gastrointestinal Disorders