■治疗药物监测用于优化炎症性肠病的抗肿瘤坏死因子生物学有效性,但它与其他生物类别的作用尚不清楚。这项研究探讨了诱导后维多珠单抗谷浓度与炎症性肠病个体的真实世界研究中生化结果之间的关系。
这项对2018年至2020年国家患者支持计划数据的回顾性分析包括436名接受维多珠单抗治疗的克罗恩病或溃疡性结肠炎患者。最佳维多珠单抗浓度阈值(在第6周和第14周)基于其预测生化正常化的能力(第30周粪便钙卫蛋白[<250µg/g],C反应蛋白[<5mg/l])。在多变量分析中评估与每个结果最佳相关的阈值。
■在克罗恩病患者中,第6周血清维多珠单抗浓度(>41.65µg/ml)预测由C-反应蛋白定义的正常化:Spearman相关系数[ρ]=-0.26,P=0.002和多变量分析(MVA)-OR:3.22,95%CI:1.32-7.87,P=0.01,第14周(>22.25µg/ml):=-0.38,P<0.0001-calprotent同样,在溃疡性结肠炎患者中,第6周vedolizumab浓度(>39.65g/ml)预测C反应蛋白定义的正常化:ρ=-0.26,P=0.005,MVA-OR:4.03,95%CI:1.30-12.52,P=0.016,第14周(>17.35µg/ml):ρ=-0.39,P=0.0001,MVA-OR:6.95,cal%CI:1.81-26.
■诱导和诱导后血清维多珠单抗与生化正常化并不一致。因此,针对维多珠单抗的前瞻性治疗药物监测不应常规纳入炎症性肠病的靶向治疗策略.
■NCT04567628。
UNASSIGNED: Therapeutic drug monitoring is used to optimize anti-tumour necrosis factor biologic effectiveness in inflammatory bowel disease, but its role with other biological classes is unclear. This study explores relationships between post-induction
vedolizumab trough concentrations and biochemical outcomes in a real-world study of individuals with inflammatory bowel disease.
UNASSIGNED: This retrospective analysis of data from a national patient support program between 2018 and 2020, included 436 individuals with Crohn\'s disease or ulcerative colitis receiving vedolizumab. Optimal
vedolizumab concentration thresholds (at weeks 6 and 14) were determined based on their ability to predict biochemical normalization (week 30 faecal calprotectin [<250 µg/g], C-reactive protein [<5 mg/l]). Thresholds best associated with each outcome were evaluated in multivariate analyses.
UNASSIGNED: Among patients with Crohn\'s disease, week 6 serum
vedolizumab concentrations (>41.65 µg/ml) predicted normalization defined by C-reactive protein: Spearman correlation coefficient [ρ] = -0.26, P = 0.002 and multivariate analysis (MVA)-OR: 3.22, 95% CI: 1.32-7.87, P = 0.01, and at week 14 (>22.25 µg/ml): ρ = -0.38, P < 0.0001, and MVA-OR: 3.21, 95% CI: 1.26-8.17 but not faecal calprotectin. Similarly, among patients with ulcerative colitis, week 6 vedolizumab concentrations (>39.65 g/ml) predicted normalization defined by C-reactive protein: ρ = -0.26, P = 0.005 and MVA-OR: 4.03, 95% CI: 1.30-12.52, P = 0.016, and at week 14 (>17.35 µg/ml): ρ = -0.39, P = 0.0001 and MVA-OR: 6.95, 95% CI: 1.81-26.77, P = 0.005, but not faecal calprotectin.
UNASSIGNED: Induction and post-induction serum
vedolizumab were not consistently associated with biochemical normalization. As such, proactive therapeutic drug monitoring for
vedolizumab should not be routinely incorporated in a treat to target strategy for inflammatory bowel disease.
UNASSIGNED: NCT04567628.