Bálint Anita, Rutka Mariann, Végh Zsuzsanna, Kürti Zsuzsanna, Gecse Krisztina B, Banai János, Bene László, Gasztonyi Beáta, Kristóf Tünde, Lakatos László, Miheller Pál, Palatka Károly, Patai Árpád, Salamon Ágnes, Szamosi Tamás, Szepes Zoltán, Tóth Gábor Tamás, Vincze Áron, Bor Renáta, Milassin Ágnes, Fábián Anna, Nagy Ferenc, Kolar Martin, Bortlik Martin, Duricova Dana, Hruba Veronika, Lukas Martin, Mitrova Katarina, Malickova Karin, Lukas Milan, Lakatos Péter L, Molnár Tamás, Farkas Klaudia
a First Department of Medicine , University of Szeged , Szeged , Hungary.
b First Department of Internal Medicine , Semmelweis University , Budapest , Hungary.
Expert Opin Drug Saf. 2017 Aug;16(8):885-890. doi: 10.1080/14740338.2017.1323330. Epub 2017 May 26.
Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres.
Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically.
Three hundred and eighty-four IBD patients were included. Twenty-eight Hungarian IBD patients (9.6%) developed infusion reaction during the treatment, 64.3% of them was previously exposed to anti TNF therapy. No infusion reaction occurred in the Czech population. CT-P13 therapy had to be stopped in 17 patients who developed infusion reaction and was switched to adalimumab in 12 patients. However in 39.3% of patients developing infusion reaction CT-P13 therapy was continued with the use of premedication. Cumulative ADA positivity rates were 8.7%, 19.3%, and 28.0% at weeks 0, 14, and 30. Previous anti-TNF-alpha exposure (30% vs. 3.1%, p < 0.001, OR 6.3 (2.7-14.6)) and ADA positivity (32.6% vs. 4.1%, p < 0.001, OR 19(5-73)) during the induction therapy were predictive factors for infusion reactions.
Patients with previous exposure to anti-TNF-alpha and ADA positivity during the induction therapy were more likely to develop infusion reactions.
肿瘤坏死因子α（TNF-α）抑制剂英夫利昔单抗生物类似药CT-P13在炎症性肠病（IBD）“真实生活”中的安全性数据仍很缺乏。我们的目的是评估13个匈牙利和1个捷克IBD中心在CT-P13治疗期间输注反应的频率和特征。
在固定随访时记录临床和安全性数据。采用酶联免疫吸附测定（ELISA）法检测谷浓度和抗药抗体（ADA）浓度。对人口统计学、临床、实验室参数与输注反应率之间的关联进行统计学评估。
共纳入384例IBD患者。28例匈牙利IBD患者（9.6%）在治疗期间出现输注反应，其中64.3%的患者既往接受过抗TNF治疗。捷克人群中未发生输注反应。17例出现输注反应患者的CT-P13治疗被迫中断，12例患者改用阿达木单抗。然而，39.3%出现输注反应的患者在使用预处理药物后继续接受CT-P13治疗。在第0、14和30周时，ADA累积阳性率分别为8.7%、19.3%和28.0%。诱导治疗期间既往抗TNF-α暴露（30% 对3.1%，p < 0.001，比值比[OR] 6.3[2.7 - 14.6]）和ADA阳性（32.6% 对4.1%，p < 0.001，OR 19[5 - 73]）是输注反应的预测因素。
诱导治疗期间既往抗TNF-α暴露和ADA阳性的患者更易发生输注反应。
