Guerra Veloz María Fernanda, Vázquez Morón Juan María, Belvis Jiménez María, Pallarés Manrique Héctor, Valdés Delgado Teresa, Castro Laria Luisa, Maldonado Pérez Belén, Benítez Roldán Antonio, Perea Amarillo Raúl, Merino Vicente, Caunedo Álvarez Ángel, Argüelles Arias Federico
Aparato Digestivo, Hospital Universitario Virgen Macarena, España.
Servicio de Digestivo, Hospital Juan Ramón Jiménez.
Rev Esp Enferm Dig. 2018 Sep;110(9):564-570. doi: 10.17235/reed.2018.5368/2017.
infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD.
this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC). All patients had switched from infliximab RP (Remicade®) to CT-P13 treatment and were followed up for 12 months. The efficacy endpoint was the change in clinical remission assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. Adverse events were monitored and recorded throughout the study.
a total of 167 patients (116 CD/51 UC) were included; 88.8% (103/116) of patients with CD were in remission at the time of the drug switch and 69.7% were in remission at 12 months. The Harvey-Bradshaw (HB) score significantly changed at 12 months (p = 0.001); 84.3% (43/51) of patients with UC were in remission at the time of the drug switch and 76.7% were in remission at 12 months. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Serious adverse events related to medication were reported in 12/167 (7.2%) cases.
switching from infliximab RP to CT-P13 is safe and effective at 12 months. The loss of efficacy at 12 months was 15.7%.
英夫利昔单抗改变了炎症性肠病（IBD）的自然病程。CT-P13等生物类似药的出现有望提高生物疗法的可及性。目前关于换药的数据有限。本研究的目的是评估IBD患者从参照产品（RP）英夫利昔单抗换用CT-P13的有效性和安全性。
这是一项针对克罗恩病（CD）和溃疡性结肠炎（UC）患者的多中心前瞻性观察性研究。所有患者均从英夫利昔单抗RP（类克®）换用CT-P13治疗，并随访12个月。疗效终点是分别根据CD和UC患者的哈维-布拉德肖评分和梅奥部分评分评估的0个月和12个月时临床缓解情况的变化。在整个研究过程中监测并记录不良事件。
共纳入167例患者（116例CD/51例UC）；88.8%（103/116）的CD患者在换药时处于缓解状态，12个月时69.7%处于缓解状态。12个月时哈维-布拉德肖（HB）评分有显著变化（p = 0.001）；84.3%（43/51）的UC患者在换药时处于缓解状态，12个月时76.7%处于缓解状态。12个月时未观察到梅奥部分评分中位数有显著变化（p = 0.87）。12/167（7.2%）例患者报告了与用药相关的严重不良事件。
从英夫利昔单抗RP换用CT-P13在12个月时是安全有效的。12个月时疗效丧失率为15.7%。
