PROSIT-BIO队列研究：一项关于接受英夫利昔单抗生物类似药治疗的炎症性肠病患者的前瞻性观察性研究。
The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar.
作者信息
Fiorino Gionata, Manetti Natalia, Armuzzi Alessandro, Orlando Ambrogio, Variola Angela, Bonovas Stefanos, Bossa Fabrizio, Maconi Giovanni, DʼIncà Renata, Lionetti Paolo, Cantoro Laura, Fries Walter, Annunziata Maria L, Costa Francesco, Terpin Maria M, Biancone Livia, Cortelezzi Claudio C, Amato Arnaldo, Ardizzone Sandro, Danese Silvio, Guidi Luisa, Rizzuto Giulia, Massella Arianna, Andriulli Angelo, Massari Alessandro, Lorenzon Greta, Ghione Silvia, Kohn Anna, Ventra Agostino, Annese Vito
机构信息
1IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Humanitas University, Rozzano, Italy; 2Department of Gastroenterology, AOU Careggi, Florence, Italy; 3IBD Unit, Complesso Integrato Columbus-Gemelli Hospital Catholic University Foundation, Rome, Italy; 4Department of Internal Medicine 2, IBD Unit, Riuniti Villa Sofia-Cervello Hospital, Palermo, Italy; 5Unit of Gastroenterology, Centro Malattie Retto-Intestinali, Sacro Cuore Don Calabria Hospital, Negrar, Italy; 6Gastroenterology Unit, IRCCS-CSS Hospital, San Giovanni Rotondo, Italy; 7Gastroenterology and IBD Unit, Luigi Sacco University Hospital, Milan, Italy; 8Unit of Gastroenterology, University of Padova, Padova, Italy; 9Department of Gastroenterology and Nutrition, Meyer Children's Hospital, Florence, Italy; 10Unit of Gastroenterology, S. Camillo-Forlanini Hospital, Rome, Italy; 11Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy; 12Department of Gastroenterology, IRCCS Policlinico, San Donato Milanese-Milano, Italy; 13Unit of Gastroenterology, AOUP, Pisa, Italy; 14Department of Gastroenterology and Endoscopy, AO Hospital, Legnano, Italy; 15Department of Systems Medicine, Gastroenterology, University of Rome Tor Vergata, Roma, Italy; 16Unit of Gastroenterology, AOU di Circolo Fondazione Macchi, Varese, Italy; 17Department of Gastroenterology, Ospedale Valduce, Como, Italy; and 18Department of Gastroenterology, Fatebenefratelli-Oftalmico Hospital, Milano, Italy.
出版信息
Inflamm Bowel Dis. 2017 Feb;23(2):233-243. doi: 10.1097/MIB.0000000000000995.
BACKGROUND
Few data are available on the safety and efficacy of infliximab biosimilar CT-P13 in patients with ulcerative colitis and Crohn's disease.
METHODS
A prospective, multicenter, cohort study using a structured database.
RESULTS
Consecutive patients (313 Crohn's disease and 234 ulcerative colitis) were enrolled from 31 referral centers; 311 patients were naive to anti-tumor necrosis factor alpha, 139 had a previous exposure to biologics, and the remaining 97 were switched to CT-P13 after a mean of 18 ± 14 infusions of infliximab. The mean follow-up was 4.3 ± 2.8 months, and the total follow-up time was 195 patient-years. After 2061 infusions, 66 serious adverse events were reported (12.1%), 38 (6.9%) of them were infusion-related reactions. The biosimilar had to be stopped in 29 (5.3%) cases for severe infusion reactions (8 naive, 19 previous exposed, and 2 switch), and in further 16 patients (2.9%) for other serious adverse events. Infusion reactions were significantly more frequent in patients pre-exposed to infliximab than to other anti-tumor necrosis factor alpha (incidence rate ratio = 2.82, 95% CI: 1.05-7.9). The efficacy of the biosimilar was evaluated in 434 patients who received treatment for at least 8 weeks, using time-to-event methods for censored observations: 35 patients were primary failures (8.1%). After further 8, 16, and 24 weeks, the efficacy estimations were 95.7%, 86.4%, and 73.7% for naive, 97.2%, 85.2%, and 62.2% for pre-exposed, and 94.5%, 90.8%, and 78.9% for switch, respectively (log-rank P = 0.64).
CONCLUSIONS
Although no direct comparison was performed, preliminary data on efficacy and safety of CT-P13 were in line with those of infliximab.
背景
关于英夫利昔单抗生物类似药CT-P13在溃疡性结肠炎和克罗恩病患者中的安全性和有效性的数据较少。
方法
一项使用结构化数据库的前瞻性、多中心队列研究。
结果
从31个转诊中心纳入了连续的患者（313例克罗恩病患者和234例溃疡性结肠炎患者）；311例患者未使用过抗肿瘤坏死因子α药物，139例曾使用过生物制剂，其余97例在平均输注英夫利昔单抗18±14次后换用CT-P13。平均随访时间为4.3±2.8个月，总随访时间为195患者年。在2061次输注后，报告了66例严重不良事件（12.1%），其中38例（6.9%）为输注相关反应。因严重输注反应，生物类似药在29例（5.3%）患者中停用（8例未使用过生物制剂者，19例曾使用过生物制剂者，2例换用者），另有16例患者（2.9%）因其他严重不良事件停用。与其他抗肿瘤坏死因子α药物相比，曾使用过英夫利昔单抗的患者输注反应明显更频繁（发病率比值=2.82，95%CI：1.05-7.9）。使用删失观察的事件发生时间方法，在434例接受治疗至少8周的患者中评估了生物类似药的疗效：35例患者为原发性治疗失败（8.1%）。在接下来的8周、16周和24周后，未使用过生物制剂者的疗效估计分别为95.7%、86.4%和73.7%，曾使用过生物制剂者分别为97.2%、85.2%和62.2%，换用者分别为94.5%、90.8%和78.9%（对数秩检验P=0.64）。
结论
虽然未进行直接比较，但CT-P13有效性和安全性的初步数据与英夫利昔单抗的数据一致。
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