在一项前瞻性全国队列研究中，生物类似物英夫利昔单抗治疗一年后的长期疗效、安全性和免疫原性。
Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort.
机构信息
1First Department of Medicine, Semmelweis University, Budapest, Hungary; 2First Department of Internal Medicine, University of Szeged, Szeged, Hungary; 3Department of Clinical Studies, Faculty of Health Sciences, Semmelweis University, Budapest, Hungary; 4Department of Gastroenterology, Military Hospital-State Health Centre, Budapest, Hungary; 5First Department of Medicine, Peterfy Hospital, Budapest, Hungary; 6Second Department of Medicine, Zala County Hospital, Zalaegerszeg, Hungary; 7Second Department of Medicine, B-A-Z County and University Teaching Hospital, Miskolc, Hungary; 8Department of Internal Medicine, Csolnoky Ferenc Regional Hospital, Veszprem, Hungary; 9Second Department of Internal Medicine, Semmelweis University, Budapest, Hungary; 10Department of Gastroenterology, University of Debrecen, Debrecen, Hungary; 11Department of Medicine and Gastroenterology, Markusovszky Hospital, Szombathely, Hungary; 12Department of Gastroenterology, Tolna County Teaching Hospital, Szekszard, Hungary; 13Department of Gastroenterology, Janos Hospital, Budapest, Hungary; 14First Department of Medicine, University of Pecs, Pecs, Hungary; 15Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary; and 16Division of Gastroenterology, McGill University, Montreal, Quebec, Canada.
出版信息
Inflamm Bowel Dis. 2017 Nov;23(11):1908-1915. doi: 10.1097/MIB.0000000000001237.
BACKGROUND
It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort.
METHODS
A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered.
RESULTS
Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD.
CONCLUSIONS
Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no new safety signals were detected.
背景
已有研究表明，生物类似药英夫利昔单抗 CT-P13 可有效诱导炎症性肠病（IBD）缓解。本研究报告了一项前瞻性全国性 IBD 队列的 1 年结果。
方法
本前瞻性、全国性、多中心、观察性队列研究旨在评估 CT-P13 在克罗恩病（CD）和溃疡性结肠炎（UC）诱导和维持治疗中的疗效和安全性。收集人口统计学数据并应用协调监测策略。分别在第 14、30 和 54 周评估临床缓解、应答和生物化学应答。登记安全性数据。
结果
共纳入 353 例连续的 IBD（209 例 CD 和 144 例 UC）患者，其中 229 例患者在最终评估时达到第 54 周终点。发病年龄：CD/UC 患者分别为 24/28 岁（中位数，四分位距：19-34/22-39）。分别有 49%、53%和 48%的 CD 患者在第 14、30 和 54 周达到临床缓解和应答，而 86%、81%和 65%的 UC 患者达到这一结果。UC 患者的临床缓解和应答率分别为 56%、41%、43%和 74%、66%、50%。在有药物假期超过 1 年的患者中，先前使用抗肿瘤坏死因子（TNF）治疗会影响临床疗效。CD 和 UC 患者的 C 反应蛋白水平在第 14 周显著下降，并在 1 年随访期间维持（均 P < 0.001）。31 例（8.8%）患者出现输注反应，32 例（9%）患者发生感染。在有先前 TNF 暴露的患者中，抗药抗体阳性率显著升高；在 CD 中，与硫唑嘌呤合用可预防 TNF 初治患者产生抗药抗体。
结论
这项前瞻性全国性队列研究的结果证实，CT-P13 可有效诱导并维持 CD 和 UC 的长期缓解，且安全性良好。疗效受先前 TNF 暴露的影响；未发现新的安全性信号。
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