Service d'Hépato-Gastro Entérologie, 3iHP, INSERM, Centre Hospitalier Universitaire de Clermont-Ferrand, Université Clermont Auvergne, Clermont-Ferrand, France; M2iSH, USC-INRA 2018, INSERM U1071, 3iHP, Université Clermont Auvergne, Clermont-Ferrand, France.
INSERM U1286 - INFINITE - Institute for Translational Research in Inflammation, Centre Hospitalier Universitaire de Lille, Université de Lille, Lille, France.
Clin Gastroenterol Hepatol. 2023 Aug;21(9):2338-2346.e3. doi: 10.1016/j.cgh.2022.08.011. Epub 2022 Aug 17.
We assessed the effectiveness of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases (IBDs) treated with or without intensified intravenous regimen.
In this multicenter observational study, IBD patients in clinical remission (partial Mayo score ≤2 or Harvey-Bradshaw index ≤4) were switched to a unique dose of subcutaneous infliximab (120 mg every other week). Pharmacological and biological data were collected at baseline, visit 1 (4-8 weeks postswitch), visit 2 (8-16 weeks postswitch), and visit 3 (16-24 weeks postswitch). Relapse was defined as clinical relapse or fecal calprotectin increase ≥150 μg/g compared with baseline.
Among 184 eligible patients, 72.3% (n = 133 of 184) agreed to switch to subcutaneous infliximab. At visit 3, a relapse occurred in 10.2% (n = 6 of 59), 7.3% (n = 3 of 38), 16.7% (n = 3 of 18), and 66.7% (n = 10 of 15) (P < .001) of patients receiving 5 mg/kg every 8 weeks, 10 mg/kg every 8 weeks, 10 mg/kg every 6 weeks, and 10 mg/kg every 4 weeks, respectively. Dose escalation to 240 mg every other week led to recapture clinical remission in 93.3% (n = 14 of 15). Infliximab serum levels increased after the switch (P < .0001) except for patients receiving 10 mg/kg every 4 weeks. In multivariable analysis, 10 mg/kg every 4 weeks regimen (odds ratio, 12.4; 95% confidence interval, 1.6-98.4; P = .017) and fecal calprotectin >250 μg/g at baseline (odds ratio, 5.4; 95% confidence interval, 1.1-27.6; P = .042) had a higher risk of relapse as well as reduced (41.7%) or stable (36.8%) infliximab serum levels between baseline and visit 1 compared with increased serum levels (12.7%) (P = .020 and P = .019, respectively). Patients' acceptability (10-point scale) was improved by the switch (6.9 ± 1.6 vs 8.6 ± 1.4; P < .0001). No severe adverse event was reported.
Switching from intravenous to subcutaneous infliximab 120 mg every other week is safe and well accepted, leading to a low risk of relapse in IBD patients except for those receiving 10 mg/kg every 4 weeks requiring 240 mg every other week.
我们评估了在接受或未接受强化静脉治疗方案的炎症性肠病（IBD）患者中，从静脉注射切换为皮下注射英夫利昔单抗的疗效。
在这项多中心观察性研究中，临床缓解（部分 Mayo 评分≤2 或 Harvey-Bradshaw 指数≤4）的 IBD 患者被切换为独特剂量的皮下注射英夫利昔单抗（每两周 120mg）。在基线、第 1 次就诊（切换后 4-8 周）、第 2 次就诊（切换后 8-16 周）和第 3 次就诊（切换后 16-24 周）收集药理学和生物学数据。复发定义为与基线相比临床复发或粪便钙卫蛋白增加≥150μg/g。
在 184 名符合条件的患者中，72.3%（n=133/184）同意切换为皮下注射英夫利昔单抗。在第 3 次就诊时，10.2%（n=6/59）、7.3%（n=3/38）、16.7%（n=3/18）和 66.7%（n=10/15）的患者（P<.001）分别出现复发，他们接受的治疗方案为每 8 周 5mg/kg、每 8 周 10mg/kg、每 6 周 10mg/kg和每 4 周 10mg/kg。将剂量增加至每两周 240mg 可使 93.3%（n=14/15）的患者再次获得临床缓解。切换后英夫利昔单抗血清水平升高（P<.0001），但每 4 周接受 10mg/kg 的患者除外。多变量分析显示，每 4 周 10mg/kg 方案（比值比，12.4；95%置信区间，1.6-98.4；P=.017）和基线时粪便钙卫蛋白>250μg/g（比值比，5.4；95%置信区间，1.1-27.6；P=.042）的患者复发风险较高，与基线至第 1 次就诊期间血清水平降低（41.7%）或稳定（36.8%）相比，血清水平升高（12.7%）（P=.020 和 P=.019）。患者的接受程度（10 分制）通过切换得到改善（6.9±1.6 vs 8.6±1.4；P<.0001）。未报告严重不良事件。
除每 4 周接受 10mg/kg 的患者需要每两周 240mg 外，从静脉注射切换为每两周 120mg 皮下注射英夫利昔单抗是安全且可接受的，可降低 IBD 患者的复发风险。
