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Number of biopsies required for accurate biomarker measurements in ulcerative colitis

The latest Alimentary Pharmacology & Therapeutics performs a validated gene expression biomarker analysis for biopsy-based clinical trials in ulcerative colitis.

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Accurate and reproducible measurement of expression of pro-inflammatory cytokines in colonic biopsies from patients with ulcerative colitis (UC) is essential for proof-of-concept and mechanism-of-action studies.

Few studies have rigorously established the number of biopsies required for accurate and reproducible biomarker measurements.

Dr Chang and colleagues from California, USA validated methods for measuring changes in gene expression in colonic biopsy samples.

The research team obtained 12 colonic biopsies from each of 6 healthy controls, 6 patients with inactive UC, and 7 patients with active UC.

Mayo endoscopic scores were used as a clinical reference standard.

Inflammatory biomarkers correlate with Mayo endoscopic subscores for each colonic region
Alimentary Pharmacology & Therapeutics

The team used quantitative PCR to assess mRNA expression of 8 known inflammatory genes.

The power to detect a reduction in gene expression in active vs. inactive UC was calculated using a linear mixed effect model.

mRNA analysis of colonic biopsies is a sensitive and feasible approach for measuring inflammatory gene expression in colonic biopsies.

The researchers found that inflammatory biomarkers correlate with Mayo endoscopic subscores for each colonic region.

For most genes, the team noted that 3 rectal biopsies from 2 to 4 patients are required to detect changes in gene expression corresponding to active vs. inactive UC to achieve a power of 80% with an alpha of 0.05.

Dr Chang's team commented, "Our data suggest that systematic measurement of inflammatory biomarkers at the mRNA level can be a valuable tool for hypothesis testing, and assessment of clinical activity and response to therapy in ulcerative colitis."

Aliment Pharmacol Ther 2014: 40(5): 477–485
25 August 2014

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