Kaniewska Magdalena, Moniuszko Andrzej, Rydzewska Grażyna
Department of Gastroenterology with Inflammatory Bowel Diseases Subdivision, Central Clinical Hospital of Ministry of Internal Affairs and Administration, Warsaw, Poland.
Faculty of Medicine and Health Sciences, Jan Kochanowski University, Kielce, Poland.
Prz Gastroenterol. 2017;12(3):169-174. doi: 10.5114/pg.2017.70468. Epub 2017 Sep 30.
The biosimilar product Inflectra has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC).
To assess the efficacy and safety of the biosimilar product Inflectra in comparison with its reference biological agent (Remicade) in rescue therapy in adult patients presenting with severe exacerbation of UC, as well as to evaluate recurrence rate during a 6-month observation after finish of treatment.
In a single-centre retrospective study, a cohort of 83 adult patients with severe UC treated at the Department of Gastroenterology with Inflammatory Bowel Diseases Subdivision of the Central Clinical Hospital of MSWiA, Warsaw was investigated. All patients received three induction doses of Remicade (28 individuals) or Inflectra (55 individuals) based on the same criteria of the National Health Fund (NFZ) Therapeutic Program (total Mayo score > 6). Activity of the disease was evaluated on the Mayo scale at qualification, after finishing the rescue treatment (after 14 weeks), and after a 6-month observation period. In all patients, sigmoidoscopy was performed at qualification and after induction (after three doses).
The studied groups were similar with respect to age and sex distribution, duration of the disease, extent of the disease (left-sided type, pancolitis), additional pharmacotherapy, and smoking. Clinical response following three induction doses was noted in 81% of patients receiving Remicade compared to 77% receiving the biosimilar product, Inflectra (NS); while clinical remission was observed in 42% receiving Remicade and 32% receiving Inflectra (NS), respectively. Endoscopic remission assessed as 0 on the Mayo scale was achieved in 4 (15%) patients on Remicade and in 7 (13%) patients on Inflectra ( = 0.45). Relapse occurred in 68% of all patients, while 51% presented with exacerbation of the disease 3 months after finishing biological treatment. In 93%, exacerbation occurred within 12 months. The recurrence rate was similar in both groups (75% with Remicade, 64% with Inflectra, respectively). Side effects occurred with similar frequency in both groups.
In the study, it was established that the biosimilar drug (Inflectra) has a similar efficacy and safety as the reference biological agent (Remicade), not only in rescue therapy, but also during a 6-month observation period in adult patients with severe UC. Low mucosal healing rate in both groups and high recurrence rate of the disease soon after finishing induction treatment indicate the need for prolonged therapy with infliximab in patients with severe UC.
生物类似药英利昔单抗（Inflectra）已获欧洲药品管理局（EMA）批准，基于对风湿性疾病患者的研究，其适应证与参比药物英夫利昔单抗相同。迄今为止，关于其在溃疡性结肠炎（UC）中的疗效和安全性的数据尚不充分。
评估生物类似药英利昔单抗（Inflectra）与其参比生物制剂（类克，Remicade）相比，在成年重症UC急性加重期挽救治疗中的疗效和安全性，并评估治疗结束后6个月观察期内的复发率。
在一项单中心回顾性研究中，对83例成年重症UC患者进行了调查，这些患者在华沙中央临床医院MSWiA胃肠病学系炎症性肠病科接受治疗。所有患者均根据国家卫生基金（NFZ）治疗计划的相同标准（梅奥总分>6）接受3剂诱导剂量的类克（28例）或英利昔单抗（Inflectra，55例）治疗。在入组时、挽救治疗结束后（14周后）以及6个月观察期后，采用梅奥量表评估疾病活动度。所有患者在入组时和诱导治疗后（3剂后）均进行了乙状结肠镜检查。
研究组在年龄、性别分布、病程、疾病范围（左侧型、全结肠炎）、附加药物治疗和吸烟方面相似。接受类克治疗的患者中，81%在3剂诱导治疗后出现临床反应，而接受生物类似药英利昔单抗（Inflectra）治疗的患者中这一比例为77%（无统计学差异）；接受类克治疗的患者中42%实现临床缓解，接受英利昔单抗（Inflectra）治疗的患者中这一比例为32%（无统计学差异）。梅奥量表评分为0的内镜缓解在接受类克治疗的4例（15%）患者和接受英利昔单抗（Inflectra）治疗的7例（13%）患者中实现（P = 0.45）。所有患者中68%出现复发，而51%在生物治疗结束后3个月出现疾病加重。93%的患者在12个月内出现加重。两组的复发率相似（类克组为75%，英利昔单抗（Inflectra）组为64%）。两组的副作用发生频率相似。
在本研究中确定，生物类似药（英利昔单抗（Inflectra））与参比生物制剂（类克，Remicade）具有相似的疗效和安全性，不仅在挽救治疗中如此，在成年重症UC患者6个月观察期内亦是如此。两组的黏膜愈合率低以及诱导治疗结束后疾病复发率高，表明重症UC患者需要延长英夫利昔单抗治疗时间。
