Inflammatory Bowel Disease Center, Department of Gastroenterology and Hepatology, Radboud university medical center, Nijmegen, The Netherlands.
Department of Gastroenterology and Hepatology, Jeroen Bosch hospital, 's-Hertogenbosch, The Netherlands.
Inflamm Bowel Dis. 2019 Jan 1;25(1):172-179. doi: 10.1093/ibd/izy227.
The infliximab biosimilar has entered daily inflammatory bowel disease (IBD) practice. However, real-life outcomes beyond 1 year after switching are scarce. We aimed to investigate the long-term drug survival, immunogenicity, and pharmacokinetics 2 years after switching to CT-P13 in IBD patients.
We performed a single-center prospective observational cohort study in all Remicade-treated IBD patients who previously switched to CT-P13. We systematically documented reasons for discontinuation, trough levels, and antidrug antibodies to infliximab (ADAs) at baseline, week 16, week 52, and week 104. Clinical and biochemical disease activity (HBI, SCCAI, CRP) and adverse events were registered.
Eighty-three patients were enrolled, 57 had Crohn's disease, 24 had ulcerative colitis, and 2 were IBD-unclassified. At week 104, 55 of 83 (66%) patients remained on CT-P13, and 3 were lost to follow-up. Reasons for discontinuation were loss of response (n = 10), adverse events (n = 8), and disease remission (n = 7). ADAs were present in 5/83 patients at baseline (before switching), in 2 patients before week 52, and no subsequent ADAs were detected until week 104. Median trough levels and clinical and biochemical disease activity at baseline, week 16, week 52 and week 104 did not significantly change.
In a prospective cohort with >2-year follow-up, 66% of IBD patients continued CT-P13 after switching from Remicade. Two new cases with ADAs were observed in year 1, but subsequently no immunogenicity was detected. These results are reassuring and suggest that switching to CT-P13 does not impact long-term clinical outcomes. 10.1093/ibd/izy227_video1izy227.video15802479819001.
英夫利昔单抗生物类似药已进入日常炎症性肠病（IBD）治疗。然而，转换后超过 1 年的真实结果却很少。我们旨在研究 IBD 患者转换为 CT-P13 后 2 年内药物的长期存活率、免疫原性和药代动力学。
我们对所有先前转换为 CT-P13 的 Remicade 治疗的 IBD 患者进行了单中心前瞻性观察队列研究。我们系统地记录了停药原因、基线、第 16 周、第 52 周和第 104 周的低谷水平和抗英夫利昔单抗抗体（ADA）。登记了临床和生化疾病活动（HBI、SCCAI、CRP）和不良事件。
共纳入 83 例患者，其中 57 例为克罗恩病，24 例为溃疡性结肠炎，2 例为 IBD 未分类。在第 104 周时，83 例患者中有 55 例（66%）继续使用 CT-P13，3 例失访。停药原因包括无应答（n=10）、不良事件（n=8）和疾病缓解（n=7）。ADA 基线（转换前）时 5/83 例（5 例），第 52 周前 2 例，随后至第 104 周未检测到其他 ADA。基线、第 16 周、第 52 周和第 104 周的中位数低谷水平以及临床和生化疾病活动均无显著变化。
在一项为期 2 年以上的前瞻性队列研究中，66%的 IBD 患者在从 Remicade 转换后继续使用 CT-P13。第 1 年观察到 2 例新的 ADA 病例，但随后未检测到免疫原性。这些结果令人放心，表明转换为 CT-P13 不会影响长期临床结局。
