Microarrays were used to investigate the the effect of vedolizumab (VDZ) therapy on colonic mucosal gene expression in UC patients and compared the changes to those observed with infliximab (IFX) therapy.
Overall design
120 colonic biopsies from 44 UC patients were collected at protocol-specified time points [week (W) 0, W6, W12 and W52] during two phase 3 trials of VDZ (GEMINI I and LTS). Biopsies were compared with 12 non-IBD colonic biopsies and colonic biopsies from 23 UC patients before and W4-6 after first IFX. Response was defined as endoscopic mucosal healing (Mayo endoscoipc subscore 0 or 1) and was assessed for VDZ at W6/12/52, and for IFX at W4-6. Total RNA extracted from mucosal biopsies was used to analyze mRNA expression via Affymetrix Human Gene 1.0 ST arrays