Real-World Effectiveness and Patient Stratification for Vedolizumab Treatment in Crohn’s Disease: A Multicenter Retrospective Study

TL;DR

This study shows that vedolizumab is effective for Crohn’s disease, especially in patients without prior biologics and with mild disease.

Contribution

A predictive nomogram was developed to identify Crohn’s patients most likely to benefit from vedolizumab treatment.

Findings

46.6% of patients achieved steroid-free remission at Week 26, dropping to 38.6% at Week 52.

Bio-naïve patients with low inflammation had higher remission rates and better treatment continuation.

The nomogram predicted steroid-free remission with an area under the curve of 0.830 at Week 26.

Abstract

Although selecting the appropriate patients for vedolizumab (VDZ) treatment was challenging, this multicenter, retrospective study evaluated the real-world effectiveness of VDZ and identified the patients who would benefit from VDZ therapy.

A total of 264 patients from three tertiary care centers specializing in inflammatory bowel disease were treated with VDZ. The outcomes assessed included steroid-free remission, clinical remission, objective response, and remission at Weeks 26 and 52. Least Absolute Shrinkage and Selection Operator regression and multivariate analyses were performed to identify independent predictors, and a nomogram was developed to predict steroid-free remission at Week 26.

The rates of steroid-free remission and clinical remission were 46.6% and 47.0% at Week 26, and both were 38.6% at Week 52. Objective response and remission were achieved in 41.5% and 14.8% of patients at Week 26, compared with 20.7% and 11.4% at Week 52. Bio-naïve patients without active intestinal fistula, and with low inflammation burden (Crohn’s Disease Activity Index ≤ 220 and C-reactive protein ≤ 10 mg/L) showed the highest rates of steroid-free remission and objective remission at both time points (all P < 0.05), along with a superior therapeutic continuation (P < 0.001). The nomogram, incorporating these factors, effectively predicted steroid-free remission at Week 26 (area under the curve = 0.830) and Week 52 (area under the curve = 0.702). VDZ was well tolerated with an adverse reaction rate of 4.2% and no serious adverse events.

VDZ was effective and safe in treating Crohn’s disease. Patients who were bio-naïve, without active intestinal fistulas, and who had milder baseline disease activity were more likely to benefit from VDZ therapy.

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