Gheorghe Cristian, Svoboda Pavel, Mateescu Bogdan
Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Bucharest, Romania.
University Hospital Ostrava, Ostrava, Czech Republic.
J Drug Assess. 2019 Jun 18;8(1):129-134. doi: 10.1080/21556660.2019.1626735. eCollection 2019.
To assess the effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn's disease (CD) or ulcerative colitis (UC). This multi-centre, observational cohort study was conducted at medical centres in Romania, Czech Republic, and Bulgaria. Effectiveness was measured using the Crohn's Disease Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and adverse events (AEs) monitoring. Analyses were performed in the safety population and were reported based on the observed case (OC) or last observation carried forward (LOCF) method. Altogether, 85 patients with CD ( = 38) or UC ( = 47) received biosimilar infliximab for up to 30 weeks. Most patients ( = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 65.8% (95% CI = 49.8-78.9) of CD patients and 55.3% (95% CI = 41.2-68.6) of UC patients showed a clinical response, and 47.4% (95% CI = 32.5-62.7) and 48.9% (95% CI = 35.3-62.8), respectively, were in remission. Statistically significant ( < 0.0001) improvements from baseline were observed in CDAI and pCAI scores (both LOCF). In the combined CD and UC population, SIBDQ was significantly improved ( < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately severe infusion reactions) were judged by investigators to be definitely related to treatment, one of which led to treatment withdrawal. Results align with those of previous studies demonstrating the effectiveness and safety of biosimilar infliximab in CD and UC.
评估生物类似药英夫利昔单抗（CT-P13）在中度至重度活动性克罗恩病（CD）或溃疡性结肠炎（UC）成人患者实际临床环境中的有效性和安全性。这项多中心观察性队列研究在罗马尼亚、捷克共和国和保加利亚的医疗中心进行。使用克罗恩病活动指数（CDAI）评估CD患者的有效性，或使用部分临床活动指数（pCAI）评估UC患者的有效性。使用简短炎症性肠病问卷（SIBDQ）测量生活质量（QoL）。根据治疗中断情况和不良事件（AE）监测评估安全性。在安全性人群中进行分析，并根据观察病例（OC）或末次观察结转（LOCF）方法报告结果。共有85例CD患者（n = 38）或UC患者（n = 47）接受生物类似药英夫利昔单抗治疗长达30周。大多数患者（n = 68；80.0%）既往未接触过英夫利昔单抗。治疗结束时，65.8%（95%CI = 49.8 - 78.9）的CD患者和55.3%（95%CI = 41.2 - 68.6）的UC患者显示出临床反应，分别有47.4%（95%CI = 32.5 - 62.7）和48.9%（95%CI = 35.3 - 62.8）的患者处于缓解状态。观察到CDAI和pCAI评分（均为LOCF）较基线有统计学显著改善（P < 0.0001）。在CD和UC合并人群中，从基线到治疗结束（OC），SIBDQ有显著改善（P < 0.0001）。研究者判定有2例不良事件（中度严重输注反应）肯定与治疗相关，其中1例导致治疗中断。结果与先前研究一致，证明生物类似药英夫利昔单抗在CD和UC中的有效性和安全性。
