Abstract
Background
Vedolizumab (VDZ) is increasingly being positioned as first-line biologic therapy for the treatment of inflammatory bowel disease (IBD) in adults, particularly for ulcerative colitis (UC). Identifying a certain subset of bio-naïve UC patients most likely to benefit from VDZ and remain on long-term maintenance therapy is important. The purpose of this study was to evaluate predictors of VDZ treatment persistence at 12 months in real-world clinical practice.
Methods
We performed a retrospective review of all adult (≥18 years) bio-naïve UC patients started on VDZ at US gastroenterology physician office infusion centres. Data collection included baseline demographics, VDZ therapy, concomitant oral agents, disease severity, and disease activity scores using the partial Mayo score (pMayo). Disease severity was characterised by prior IBD-related surgery and IBD-related healthcare resource utilisation within 1 year of VDZ initiation. Clinical response was assessed at baseline, 6 weeks, and 14 weeks and defined as a pMayo reduction of ≥2 points. Patients were divided into two cohorts, those persisting on VDZ at 12 months and those discontinuing VDZ prior to 12 months. Logistic regression analysis was used to determine predictors associated with persistence.
Results
A total of 141 UC patients receiving VDZ as first-line biologic therapy were identified: mean age 44 ± 14.5 years, male gender 82 (58%), median disease duration 5.5 (IQR 1.6–13.3) years. VDZ treatment persistence at 12 months was observed in 102 (72%) patients (Figure 1). The remaining 39 patients discontinued VDZ within the first 12 months. Amongst those who discontinued VDZ, reasons included lack or loss of response in 35 (90%), antibodies in 3 (8%), and intolerance in 1 (3%). In the logistic regression analysis, the only factor associated with VDZ treatment persistence was clinical response at 14 weeks (OR 6.5 [95% CI 2.9–14.5]). No other variables (age, gender, smoking status, disease duration, concomitant oral agents, or severity of illness) influenced persistence at 12 months.
Conclusion
Almost three-fourths of bio-naïve UC patients treated with vedolizumab experienced treatment persistence at 12 months. Our data suggest that response to induction may be used to predict those who will remain on maintenance therapy.
Immune Cells and Transcriptional Signatures Revealed Novel Regulators and Predict Clinical Response to Biologic Therapy in Ulcerative Colitis
