Department for Internal Medicine I, University Hospital Schleswig-Holstein, Kiel University, Arnold-Heller Straße 3, 24105 Kiel, Germany.
Department of Gastroenterology, Amsterdam University Medical Centers, De Boelelaan 1117, HV 1081, Amsterdam, The Netherlands.
Dig Liver Dis. 2024 Jul;56(7):1204-1212. doi: 10.1016/j.dld.2023.12.013. Epub 2024 Feb 15.
Pharmacokinetic non-inferiority of subcutaneous (SC) to intravenous (IV) CT-P13 maintenance therapy was demonstrated in a randomized trial (NCT02883452). This post hoc analysis evaluated longitudinal clinical outcomes with the two infliximab treatment strategies.
Patients with Crohn's disease or ulcerative colitis received CT‑P13 IV loading doses (5 mg/kg; Week [W] 0 and W2) before randomization (1:1) to receive CT-P13 SC (body weight-based dosing every 2 weeks [Q2W]; W6-54; 'SC maintenance group') or CT‑P13 IV (5 mg/kg Q8W; W6-22) then CT-P13 SC (Q2W; W30-54; 'IV-to-SC switch group'). Paired W30/W54 patient-level data were analyzed.
Fifty-three (IV-to-SC switch) and fifty-nine (SC maintenance) patients were analyzed. Median trough serum CT-P13 concentrations were significantly higher at W54 versus W30 in the IV-to-SC switch group (20.4 versus 2.3 µg/mL; p < 0.00001), while remaining consistent in the SC maintenance group. Statistically significant improvements in pharmacokinetics, efficacy, fecal calprotectin levels, and quality of life were seen following switch to SC administration at W30 in the IV-to-SC switch group; safety findings were similar pre- and post-switch.
Formulation switching from IV to SC infliximab maintenance therapy was well tolerated and may provide additional clinical improvements. Findings require confirmation in larger prospective studies.
在一项随机试验（NCT02883452）中，皮下（SC）给予 CT-P13 维持治疗与静脉内（IV）给予 CT-P13 的药代动力学非劣效性得到了证实。本事后分析评估了两种英夫利昔单抗治疗策略的纵向临床结局。
克罗恩病或溃疡性结肠炎患者在随机分组前（1:1）接受 CT-P13 IV 负荷剂量（5mg/kg；第 0 周和第 2 周[W]），然后随机接受 CT-P13 SC（基于体重每 2 周一次给药[Q2W]；W6-54；“SC 维持组”）或 CT-P13 IV（5mg/kg Q8W；W6-22），然后给予 CT-P13 SC（Q2W；W30-54；“IV 转换为 SC 组”）。对 W30/W54 患者水平的数据进行了配对分析。
对 53 例（IV 转换为 SC 组）和 59 例（SC 维持组）患者进行了分析。与 W30 相比，IV 转换为 SC 组患者 W54 时的 CT-P13 血清谷浓度显著升高（20.4 与 2.3μg/mL；p<0.00001），而 SC 维持组患者的 CT-P13 血清谷浓度则保持一致。IV 转换为 SC 组患者在 W30 时转换为 SC 给药后，药代动力学、疗效、粪便钙卫蛋白水平和生活质量均有显著改善；转换前后安全性结果相似。
从 IV 转换为 SC 英夫利昔单抗维持治疗的剂型转换耐受性良好，可能提供额外的临床改善。这些发现需要在更大的前瞻性研究中得到证实。
