Predictors of the efficacy of vedolizumab in patients with ulcerative colitis

Abstract

Vedolizumab is a treatment option for ulcerative colitis but data on predictors of treatment response remain insufficient to establish personalized treatment strategies. We aimed to investigate the real-world effectiveness of vedolizumab in adult patients with ulcerative colitis and explore factors involved in predicting treatment response. This single-center, single-arm, prospective observational study included 26 patients with clinically active ulcerative colitis patients' characteristics at baseline, epidemiological information, existing treatment, clinical activity index score, endoscopic score, and blood test data were collected. Serum levels of tumor necrosis factors alpha, interferon gamma, interleukin-4, interleukin-6, interleukin-10, interleukin-17, soluble mucosal addressin cell adhesion molecule 1, and soluble vascular cell adhesion molecule 1 were measured. Patient characteristics in the remission and non-remission groups were compared based on these parameters. Clinical remission at 6 weeks of treatment occurred in 9 (35%) of the 26 patients. At 14 weeks, clinical remission was observed in 11 patients (42%). There were no significant differences pertaining to age, sex, duration of disease, extent of disease, steroid resistance, or prior treatment with biological agents among the two groups after 14 weeks of treatment. Hemoglobin ≥ 11.5 g/dL (odds ratio, 15.0; 95% confidence interval, 1.50-149; P=0.014) and soluble mucosal addressin cell adhesion molecule 1 ≥ 765 pg/mL (odds ratio, 17.3; 95% confidence interval, 2.36-127; P=0.004) were significant factors. In conclusion, hemoglobin and serum soluble mucosal addressin cell adhesion molecule 1 levels are factors correlated with the therapeutic efficacy of vedolizumab.

Keywords: MAdCAM-1; hemoglobin; predictive factor; ulcerative colitis; vedolizumab.

Fig. 1

Clinical remission rates following VDZ treatment Fig. 1A: Clinical remission rates after 6 and 14 weeks of VDZ treatment. Fig. 1B: Clinical remission rates after 6 and 14 weeks of treatment in patients with and without prior exposure to TNFα antagonist. Fig. 1C: Clinical remission rates after 6 and 14 weeks of treatment in patients with and without concomitant use of immunosuppressant. VDZ: vedolizumab TNF: tumor necrosis factor

Fig. 2

Molecular characteristics of the remission and non-remission groups at 6 weeks The horizontal lines represent median values; the lower and upper boundaries of the boxes represent the 25th and 75th percentiles, respectively; the whiskers represent the highest and lowest points. Fig. 2A: Comparison of colonic mucosal cytokine-related mRNA expression between the remission and non-remission groups. Fig. 2B: Comparison of serum cytokine concentrations between the remission and non-remission groups. TNF: tumor necrosis factor IFN: interferon IL: interleukin MAdCAM-1: mucosal addressin cell adhesion molecule 1 VCAM-1: vascular cell adhesion molecule 1 sMAdCAM-1: soluble mucosal addressin cell adhesion molecule 1 sVCAM-1: soluble vascular cell adhesion molecule 1

Fig. 3

Molecular characteristics of the remission and non-remission groups at 14 weeks The horizontal lines represent median values; the lower and upper boundaries of the boxes represent the 25th and 75th percentiles, respectively; the whiskers represent the highest and lowest points. Fig. 3A: Comparison of colonic mucosal cytokine-related mRNA expression between the remission and non-remission groups. Fig. 3B: Comparison of serum cytokine concentrations between the remission and non-remission groups. TNF: tumor necrosis factor IFN: interferon IL: interleukin MAdCAM-1: mucosal addressin cell adhesion molecule 1 VCAM-1: vascular cell adhesion molecule 1 sMAdCAM-1: soluble mucosal addressin cell adhesion molecule 1 sVCAM-1: soluble vascular cell adhesion molecule 1

Fig. 4

ROC curves for Hb and sMAdCAM-1 ROC: receiver operating characteristics Hb: hemoglobin sMAdCAM-1: soluble mucosal addressin cell adhesion molecule 1 AUC: area under the curve