Tursi Antonio, Allegretta Leonardo, Chiri Stefania, Della Valle Nicola, Elisei Walter, Forti Giacomo, Lorenzetti Roberto, Mocci Giammarco, Penna Antonio, Pranzo Giuseppe, Ricciardelli Cristina, Picchio Marcello
Gastroenterology Service, ASL BAT, Andria, Italy -
Division of Gastroenterology, Santa Caterina Novella Hospital, Galatina, Lecce, Italy.
Minerva Gastroenterol Dietol. 2017 Dec;63(4):313-318. doi: 10.23736/S1121-421X.17.02402-3. Epub 2017 Mar 14.
The aim of this study was to assess the efficacy and safety of infliximab biosimilar (IFX) IFX CT-P13 in inducing and maintaining remission in ulcerative colitis (UC) outpatients in Italian primary gastroenterology centers.
Patients were prospectively assessed at entry, after 8, 12, 24, 36, and therefore 52 weeks. Clinical activity was rated as per the Mayo Score. The primary endpoint was reaching of clinical remission (Mayo Score ≤2). Several secondary endpoints were clinical response to treatment, reaching of mucosal healing (MH), safety of the drug.
Twenty-nine patients (16 males and 13 females, mean age 45 years, range 35-42 years) were enrolled. Eleven (37.9%) patients had previous exposure to other anti-TNF-α. Clinical remission was present in 78.5% at week 24, and in 100% at 12-month follow-up. Subgroup analysis did not reveal significant differences in clinical remission between IFX-naïve patients and patients switching from originator to IFX biosimilar. A clinical response was observed in 92.3% at week 8, in 50.0% at week 16, in 100% at week 36 and in 100% at 12-month follow-up. MH occurred in 85.7% at week 24, and in 100% at 12-month follow-up Reduction of steroids was achieved in 92.3% at week 8, and in 100% during follow-up. One patient underwent proctocolectomy 3 weeks after starting IFX CT-P13. The median C-reactive protein and calprotectin levels during follow-up were significantly reduced during follow-up. No adverse events were observed during follow-up.
IFX CT-P13 seems to be very effective and safe in real-life experience at primary IBD centers.
本研究旨在评估英夫利昔单抗生物类似药（IFX）IFX CT-P13在意大利初级胃肠病学中心诱导和维持溃疡性结肠炎（UC）门诊患者缓解的疗效和安全性。
在患者入组时、8周、12周、24周、36周以及52周时对患者进行前瞻性评估。根据梅奥评分对临床活动进行评分。主要终点是达到临床缓解（梅奥评分≤2）。几个次要终点是治疗的临床反应、达到黏膜愈合（MH）、药物安全性。
共纳入29例患者（16例男性和13例女性，平均年龄45岁，范围35 - 42岁）。11例（37.9%）患者既往曾使用过其他抗TNF-α药物。24周时临床缓解率为78.5%，12个月随访时为100%。亚组分析显示，初治IFX患者与从原研药转换为IFX生物类似药的患者在临床缓解方面无显著差异。8周时临床反应率为92.3%，16周时为50.0%，36周时为100%，12个月随访时为100%。24周时MH发生率为85.7%，12个月随访时为100%。8周时92.3%的患者实现了类固醇减量，随访期间为100%。1例患者在开始使用IFX CT-P13 3周后接受了全结肠直肠切除术。随访期间，C反应蛋白和钙卫蛋白水平中位数显著降低。随访期间未观察到不良事件。
在初级炎症性肠病中心的实际应用中，IFX CT-P13似乎非常有效且安全。
