Edinburgh IBD Unit, Western General Hospital, Edinburgh, UK.
Department of Gastroenterology and Hepatology, Reina Sofía University Hospital, Córdoba, Spain.
United European Gastroenterol J. 2023 Mar;11(2):179-188. doi: 10.1002/ueg2.12357. Epub 2023 Feb 17.
Switching from originator infliximab (IFX) to biosimilar IFX is effective and safe. However, data on multiple switching are scarce. The Edinburgh inflammatory bowel disease (IBD) unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021).
The primary endpoint of this study was to assess CT-P13 persistence following switch from SB2. Secondary endpoints included persistence stratified by the number of biosimilar switches (single, double and triple), effectiveness and safety.
We performed a prospective, observational, cohort study. All adult IBD patients on IFX biosimilar SB2 underwent an elective switch to CT-P13. Patients were reviewed in a virtual biologic clinic with protocol driven collection of clinical disease activity, C-reactive protein (CRP), faecal calprotectin (FC), IFX trough/antibody levels, and drug survival.
297 patients (CD n = 196 [66%], ulcerative colitis/inflammatory bowel disease unclassified n = 101, [34%]) were switched (followed-up: 7.5 months [6.8-8.1]). This was the third, second and first IFX switch for 67/297 (22.5%), 138/297 (46.5%) and 92/297 (31%) of the cohort respectively. 90.6% of patients remained on IFX during follow-up. The number of switches was not independently associated with IFX persistence after adjusting for confounders. Clinical (p = 0.77), biochemical (CRP ≤5 mg/ml; p = 0.75) and faecal biomarker (FC<250 µg/g; p = 0.63) remission were comparable at baseline, week 12 and week 24.
Multiple successive switches from IFX originator to biosimilars are effective and safe in patients with IBD, irrespective of the number of IFX switches.
从原研英夫利昔单抗（IFX）转换为生物类似药 IFX 是有效且安全的。然而，关于多次转换的数据很少。爱丁堡炎症性肠病（IBD）单位已经进行了三个转换计划：（1）从 Remicade 转换为 CT-P13（2016 年），（2）从 CT-P13 转换为 SB2（2020 年），以及（3）从 SB2 转换为 CT-P13（2021 年）。
本研究的主要终点是评估从 SB2 转换后 CT-P13 的持续情况。次要终点包括按生物类似药转换次数（单次、双次和三次）分层的持续情况、有效性和安全性。
我们进行了一项前瞻性、观察性、队列研究。所有接受 IFX 生物类似药 SB2 治疗的成年 IBD 患者均进行了选择性转换为 CT-P13。患者在虚拟生物制剂诊所接受评估，方案驱动采集临床疾病活动度、C 反应蛋白（CRP）、粪便钙卫蛋白（FC）、IFX 谷浓度/抗体水平和药物生存情况。
297 名患者（CD n=196 [66%]，溃疡性结肠炎/未分类 IBD n=101 [34%]）进行了转换（随访：7.5 个月[6.8-8.1]）。这是该队列中第 67/297（22.5%）、138/297（46.5%）和 92/297（31%）名患者的第三次、第二次和第一次 IFX 转换。90.6%的患者在随访期间仍使用 IFX。在调整混杂因素后，转换次数与 IFX 持续时间无关。基线、第 12 周和第 24 周时，临床（p=0.77）、生化（CRP≤5mg/ml；p=0.75）和粪便生物标志物（FC<250μg/g；p=0.63）缓解情况相似。
在 IBD 患者中，从 IFX 原研药多次转换为生物类似药是有效且安全的，无论 IFX 转换次数如何。
