Trial reportInflammatory bowel diseases2020
Association of Biomarker Cutoffs and Endoscopic Outcomes in Crohn's Disease: A Post Hoc Analysis From the CALM Study.
Trial report in Inflammatory bowel diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 25 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Surrogate markers of mucosal healing in inflammatory bowel disease: A systematic review.World journal of gastroenterology · 2021Pooled it
- Identification of oxidative stress-associated biomarkers for inflammatory bowel disease through integrated machine learning and weighted gene co-expression network analysis.Frontiers in immunology · 2026Article
- Comparative Effectiveness and Safety of Risankizumab vs Ustekinumab in Crohn's Disease: A Real-World Retrospective Cohort Study from Taiwan.Journal of inflammation research · 2026Article
- Association between serum leucine-rich alpha-2-glycoprotein levels and characteristic enteroclysis findings in small intestinal Crohn's disease.Crohn's & colitis 360 · 2026Article
- Leucine-rich alpha-2 glycoprotein in combination with C-reactive protein for predicting endoscopic activity in Crohn's disease: a single-centre, cross-sectional study.Annals of medicine · 2025Article
- Risankizumab Is Associated With Normalization of Biomarkers in Patients With Crohn's Disease: Results From the Phase 3 ADVANCE, MOTIVATE, and FORTIFY Studies.Journal of Crohn's & colitis · 2025Article
- Computed tomography enterography-based radiomics for assessing mucosal healing in patients with small bowel Crohn's disease.World journal of gastroenterology · 2025Article
- Management of Crohn's disease in Taiwan: consensus guideline of the Taiwan Society of Inflammatory Bowel Disease updated in 2023.Intestinal research · 2024Article
- Tight control using fecal calprotectin and early disease intervention increase the rates of transmural remission in Crohn's disease.United European gastroenterology journal · 2024Article
- Crohn's disease management: translating STRIDE-II for UK clinical practice.Therapeutic advances in gastroenterology · 2024Review
- Review
- Treatment escalation and de-escalation decisions in Crohn's disease: Delphi consensus recommendations from Japan, 2021.Journal of gastroenterology · 2023Review
- Diagnostic Accuracy of Fecal Calprotectin for Predicting Relapse in Inflammatory Bowel Disease: A Meta-Analysis.Journal of clinical medicine · 2023Review
- Article
- Infliximab trough level combined with inflammatory biomarkers predict long-term endoscopic outcomes in Crohn's disease under infliximab therapy.World journal of gastroenterology · 2022Article
- Course of Fecal Calprotectin after mRNA SARS-CoV-2 Vaccination in Patients with Inflammatory Bowel Diseases.Vaccines · 2022Article
- Mucosal Healing in Crohn's Disease: Bull's Eye or Bust? The "Relative" Con Position.Inflammatory intestinal diseases · 2022Review
- Exploring the concept of deep remission in Crohn's disease: correlation between transmural healing and biomarkers.Therapeutic advances in gastroenterology · 2022Article
- Role of Biomarkers in the Diagnosis and Treatment of Inflammatory Bowel Disease.Life (Basel, Switzerland) · 2021Review
- A Patient Self-Made Point-of-Care Fecal Test Improves Diagnostic Accuracy Compared with Fecal Calprotectin Alone in Inflammatory Bowel Disease Patients.Diagnostics (Basel, Switzerland) · 2021Article
Corrections and comments
- Erratum issued
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCALM was a randomized phase 3 trial in patients with Crohn's disease (CD) that demonstrated improved endoscopic outcomes when treatment was escalated based on cutoffs for inflammatory biomarkers, fecal calprotectin (FC), C-reactive protein (CRP), and CD Activity Index (CDAI) remission vs CDAI response alone. The purpose of this post hoc analysis of CALM was to identify drivers of treatment escalation and evaluate the association between biomarker cutoff concentrations and endoscopic end points.
methodsThe proportion of patients achieving CD Endoscopic Index of Severity (CDEIS) <4 and no deep ulcers 48 weeks after randomization was evaluated according to CRP <5 mg/L or ≥5 mg/L and FC <250 μg/g or ≥250 μg/g. Subgroup analyses were performed according to disease location, and sensitivity analyses were conducted in patients with elevated CRP and/or FC at baseline. The association between endoscopic end points and biomarker cutoffs was performed using χ 2 test.
resultsThe proportion of patients who achieved the primary end point CDEIS <4 and no deep ulcers was significantly greater for those with FC <250 µg/g (74%; P < 0.001), with an additive effect for CRP <5 mg/L. The association of FC <250 µg/g with improved endoscopic outcomes was independent of disease location, although the greatest association was observed for ileocolonic disease. Fecal calprotectin <250 µg/g, CRP <5 mg/L, and CDAI <150 gave a sensitivity/specificity of 72%/63% and positive/negative predictive values of 86%/42% for CDEIS <4 and no deep ulcers 48 weeks after randomization.
conclusionThis post hoc analysis of CALM demonstrated that a cutoff of FC <250 µg/g is a useful surrogate marker for mucosal healing in CD.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.