Department of Gastroenterology, University Hospital of Saint-Etienne, Saint-Etienne, France.
Department of Gastroenterology, Lyon Sud hospital, Hospices Civils de Lyon, University Claude Bernard Lyon 1, Lyon, France.
J Crohns Colitis. 2024 May 31;18(5):679-685. doi: 10.1093/ecco-jcc/jjad188.
The relationship between subcutaneous infliximab [SC-IFX] concentrations and favourable therapeutic outcomes in patients with Crohn's disease [CD] and ulcerative colitis [UC] remains elusive.
This cross-sectional study included consecutive adult patients with inflammatory bowel disease [IBD] treated with SC-IFX at a maintenance dose of 120 mg/2 weeks. Investigated therapeutic outcomes included sustained clinical remission; composite clinical and biomarker remission [clinical remission and C-reactive protein <5 mg/L]; biochemical remission [faecal calprotectin <250 µg/g]; and deep remission [clinical, biological, and biochemical remission].
Of 91 patients identified, 71 qualified for inclusion in the study [70% with CD; 27% with concomitant immunomodulators]. At the time of drug concentration measurement [median 13.5 months after switch], 55 [77%] patients had sustained clinical remission; n = 44 [62%] composite clinical and biomarker remission; n = 40 [56%] biochemical remission; and n = 31 [43%] deep remission. The mean SC-IFX concentrations were significantly higher in patients with sustained clinical remission [p = 0.014]; composite clinical and biomarker remission [p = 0.003]; biochemical remission [p < 0.001]; and deep remission [p < 0.001] compared to patients without having these outcomes. In multivariate analysis, SC-IFX concentration was the only factor independently associated with sustained clinical remission (odds ratio [OR]: 4.7, 95% confidence interval [CI]: 3.1-12.2, p = 0.005); clinical and biomarker remission [OR: 9.21, 95% CI: 6.09-18.7, p = 0.006]; biochemical remission [OR: 37, 95% CI: 14-39.3, p < 0.001]; and deep remission [OR: 29, 95% CI: 15.7-37.4, p < 0.001]. The optimal SC-IFX concentration cut-off associated with deep remission based on ROC analysis was 20 µg/mL [sensitivity: 0.91, specificity: 0.80, accuracy: 0.85]. Combination with an immunomodulator failed to improve SC-IFX pharmacokinetics.
Higher SC-IFX concentrations are associated with higher rates of favourable therapeutic outcomes in IBD patients. Serum SC-IFX concentrations >20 µg/mL were significantly associated with deep remission.
皮下注射英夫利昔单抗[SC-IFX]浓度与克罗恩病[CD]和溃疡性结肠炎[UC]患者的治疗效果之间的关系仍不清楚。
本横断面研究纳入了在维持剂量为 120mg/2 周时接受 SC-IFX 治疗的炎症性肠病[IBD]成年患者。研究的治疗结果包括持续的临床缓解；复合临床和生物标志物缓解[临床缓解和 C-反应蛋白<5mg/L]；生化缓解[粪便钙卫蛋白<250μg/g]；和深度缓解[临床、生物学和生化缓解]。
在确定的 91 名患者中，71 名符合纳入研究的标准[70%患有 CD；27%同时使用免疫调节剂]。在药物浓度测量时[转换后中位数 13.5 个月]，55 名[77%]患者持续临床缓解；n=44 [62%]复合临床和生物标志物缓解；n=40 [56%]生化缓解；n=31 [43%]深度缓解。持续临床缓解[n=55]；复合临床和生物标志物缓解[n=44]；生化缓解[n=40]；和深度缓解[n=31]患者的 SC-IFX 浓度明显高于无这些结果的患者（p=0.014）。在多变量分析中，SC-IFX 浓度是与持续临床缓解唯一相关的因素（优势比[OR]：4.7，95%置信区间[CI]：3.1-12.2，p=0.005）；临床和生物标志物缓解[n=44]（OR：9.21，95%CI：6.09-18.7，p=0.006）；生化缓解[n=40]（OR：37，95%CI：14-39.3，p<0.001）；和深度缓解[n=31]（OR：29，95%CI：15.7-37.4，p<0.001）。基于 ROC 分析，与深度缓解相关的最佳 SC-IFX 浓度截断值为 20μg/mL[灵敏度：0.91，特异性：0.80，准确性：0.85]。与免疫调节剂联合使用未能改善 SC-IFX 药代动力学。
较高的 SC-IFX 浓度与 IBD 患者更高的治疗效果相关。血清 SC-IFX 浓度>20μg/mL 与深度缓解显著相关。
