Health Sciences Postgraduate Program, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.
Gastroenterology Department, Universidade Positivo, Curitiba, Brazil.
Tech Coloproctol. 2024 Jul 20;28(1):86. doi: 10.1007/s10151-024-02953-z.
Several studies associate the presence of higher serum concentrations of infliximab (IFX) with fistula healing in perianal Crohn's disease (CD). This study aimed to evaluate serum IFX concentrations in patients with perianal fistulizing CD (PFCD) in the presence or absence of general, clinical, and radiological activities.
This was a cross-sectional study in patients with PFCD during maintenance treatment with IFX from two centers. Serum IFX concentrations were measured before their next infusion and anal fistulas were evaluated by clinical examination and magnetic resonance imaging (MRI), whenever possible, performed 90 days before or after serum collection. According to clinical scores, radiological activity, and disease markers, patients were classified as in remission or active disease. Mean serum IFX concentrations were compared between the groups.
Thirty-eight patients with PFCD were included. Demographic characteristics were similar in patients with remission or active disease. The overall mean serum IFX concentration of the entire sample (n = 38) was 5.21 ± 4.75 μg/mL (median 3.63; IQR 1.44-8.82). Serum IFX levels were 6.25 ± 5.34 μg/mL (median 3.62; IQR 1.95-11.03) in the 23 (60.5%) patients in remission and 3.63 ± 3.24 μg/mL (median 3.63; IQR 1.32-6.43; p = 0.226) in the 15 (39 .5%) who presented active disease. When evaluating general, clinical, and radiological activity of PFCD, and deep remission in isolation, no statistical difference between the groups was observed (p = 0.226, p = 0.418, p = 0.126, and p = 0.232, respectively). The 13 (34.2%) patients with an optimized dose of IFX had significantly higher serum concentrations than the remaining 25 (65.8%) with a standard dose: 8.33 ± 4.41 μg/mL (median 8.36; IQR 3.82-11.20) vs. 3.59 ± 4.13 μg/mL (median 1.97; IQR 1.18-3.85) -p = 0.002. Patients in remission and with an optimized IFX dose had significantly higher serum IFX concentrations than those with a standard dose (p = 0.006), whereas no significant difference was observed among those with active disease (p = 0.083).
There were no differences in IFX serum concentrations in patients with clinical or radiological active PFCD as compared with those in remission. Patients with an optimized IFX dose had significantly higher serum concentrations than those with a standard dose. Patients in remission and with an optimized IFX dose had significantly higher serum concentrations than those with a standard dose.
几项研究表明，较高的英夫利昔单抗（IFX）血清浓度与肛周克罗恩病（CD）的瘘管愈合有关。本研究旨在评估接受 IFX 维持治疗的肛周瘘管性 CD（PFCD）患者在存在或不存在一般、临床和影像学活动时的血清 IFX 浓度。
这是在两个中心进行的 PFCD 患者的横断面研究。在进行下一次输注前测量血清 IFX 浓度，并尽可能在血清采集前 90 天进行临床检查和磁共振成像（MRI）评估肛痿。根据临床评分、影像学活动和疾病标志物，患者被分类为缓解或活动期疾病。比较缓解组和活动组的平均血清 IFX 浓度。
共纳入 38 例 PFCD 患者。缓解组和活动组患者的人口统计学特征相似。整个样本（n=38）的总体平均血清 IFX 浓度为 5.21±4.75μg/ml（中位数 3.63；IQR 1.44-8.82）。23 例（60.5%）缓解患者的血清 IFX 水平为 6.25±5.34μg/ml（中位数 3.62；IQR 1.95-11.03），15 例（39.5%）活动患者的血清 IFX 水平为 3.63±3.24μg/ml（中位数 3.63；IQR 1.32-6.43；p=0.226）。在评估 PFCD 的一般、临床和影像学活动以及深层缓解时，各组之间均无统计学差异（p=0.226，p=0.418，p=0.126 和 p=0.232）。13 例（34.2%）接受优化 IFX 剂量的患者的血清浓度明显高于其余 25 例（65.8%）接受标准剂量的患者：8.33±4.41μg/ml（中位数 8.36；IQR 3.82-11.20）比 3.59±4.13μg/ml（中位数 1.97；IQR 1.18-3.85）-p=0.002。缓解且接受优化 IFX 剂量的患者的血清 IFX 浓度明显高于接受标准剂量的患者（p=0.006），而活动期患者之间无显著差异（p=0.083）。
与缓解患者相比，临床或影像学活动期 PFCD 患者的 IFX 血清浓度无差异。接受优化 IFX 剂量的患者的血清浓度明显高于接受标准剂量的患者。缓解且接受优化 IFX 剂量的患者的血清 IFX 浓度明显高于接受标准剂量的患者。
