英夫利昔单抗生物类似药在炎症性肠病中的PROSIT队列研究：意大利全国范围内关于有效性和安全性的长期随访
The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy.
作者信息
Armuzzi Alessandro, Fiorino Gionata, Variola Angela, Manetti Natalia, Fries Walter, Orlando Ambrogio, Maconi Giovanni, Bossa Fabrizio, Cappello Maria, Biancone Livia, Cantoro Laura, Costa Francesco, D'Incà Renata, Lionetti Paolo, Principi Mariabeatrice, Castiglione Fabiana, Annunziata Maria L, Di Sabatino Antonio, Di Girolamo Maria, Terpin Maria M, Cortelezzi Claudio C, Saibeni Simone, Amato Arnaldo, Ardizzone Sandro, Guidi Luisa, Danese Silvio, Massella Arianna, Ventra Agostino, Rizzuto Giulia, Massari Alessandro, Perri Francesco, Annese Vito
机构信息
IBD Unit, Presidio Columbus, Fondazione Policlinico Gemelli Università Cattolica, Rome, Italy.
Humanitas Research Hospital and University, Gastroenterology and IBD Center, Rozzano, Italy.
出版信息
Inflamm Bowel Dis. 2019 Feb 21;25(3):568-579. doi: 10.1093/ibd/izy264.
BACKGROUND
We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13.
METHODS
A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings.
RESULTS
Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naïve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C). All patients were included in the safety evaluation with a mean follow-up of 345 ± 215 days and a total number of 6501 infusions. One hundred fifty-four SAEs were reported (19%), leading to cessation of the biosimilar in 103 subjects (12.7%). Infusion reactions were 71, leading to cessation of the biosimilar in 53 subjects (6.5%), being significantly more frequent in patients pre-exposed to anti-TNFα (P = 0.017). The efficacy of therapy was calculated in 754 IBD patients, with a mean follow-up of 329 ± 202 days. Forty-eight patients had a primary failure (6.4%), and 188 (25.6%) lost response during follow-up. Six hundred twenty-eight (364 CD) and 360 IBD patients (222 CD) completed the follow-up at 6 and 12 months, respectively. At 12 months, patients without loss of response were 71%, 64%. and 82% in groups A, B, and C, respectively (log rank P = 0.01). Clinical/endoscopic scores and inflammatory biomarkers dropped significantly in CD and UC patients (P = 0.01 and P < 0.0001) compared with baseline.
CONCLUSIONS
In this large prospective cohort, no further signals of difference in safety and effectiveness of CT-P13 in IBD has been observed.
背景
我们报告一项前瞻性的全国性队列研究，评估CT-P13的安全性和有效性。
方法
使用结构化数据库记录严重不良事件（SAEs）、临床缓解/反应、炎症生物标志物（CRP和钙卫蛋白）以及内镜检查结果。
结果
共纳入810例炎症性肠病（IBD）患者（452例克罗恩病[CD]）。459例患者既往未使用过抗TNFα（A组），196例曾有过使用经历（B组），其余155例换用CT-P13（C组）。所有患者均纳入安全性评估，平均随访345±215天，共进行6501次输注。报告了154例SAEs（19%），导致103例受试者（12.7%）停用生物类似药。输注反应有71例，导致53例受试者（6.5%）停用生物类似药，在既往使用过抗TNFα的患者中更为常见（P=0.017）。对754例IBD患者计算治疗效果，平均随访329±202天。48例患者出现原发性治疗失败（6.4%），188例（25.6%）在随访期间失去反应。628例（364例CD）和360例IBD患者（222例CD）分别在6个月和12个月完成随访。在12个月时，A、B和C组未失去反应的患者分别为71%、64%和82%（对数秩检验P=0.01）。与基线相比，CD和UC患者的临床/内镜评分及炎症生物标志物显著下降（P=0.01和P<0.0001）。
结论
在这个大型前瞻性队列中，未观察到CT-P13在IBD安全性和有效性方面有进一步的差异信号。
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