Fiorino Gionata, Bonovas Stefanos, Cicerone Clelia, Allocca Mariangela, Furfaro Federica, Correale Carmen, Danese Silvio
a IBD Center, Department of Gastroenterology , Humanitas Research Hospital , Milan , Italy.
b Department of Biomedical Sciences , Humanitas University , Milan , Italy.
Expert Opin Drug Saf. 2017 Apr;16(4):437-443. doi: 10.1080/14740338.2017.1298743. Epub 2017 Mar 10.
Biological agents are effective in ulcerative colitis (UC). Currently, 3 anti-TNF agents (infliximab, adalimumab, and golimumab) and 1 anti-integrin agent (vedolizumab) are approved for the treatment of UC. The mechanism of action of biologic agents can also give rise to several side effects, some even serious. It remains uncertain to what extent biologic treatments may be associated with an increased rate of infections, malignancies and other adverse events Areas covered: Our aim is to review the relevant data available in the literature and briefly summarize the safety profile of biological therapy in UC. We performed a literature search using the OVID, MEDLINE, PUBMED and EMBASE databases. Also other relevant sources of safety data were also used. Expert opinion: All biological agents currently used in UC are relatively safe. Accurate prevention measures and screening prior to start such therapies, and regular surveillance programs are strongly recommend to minimize any risk of infections, malignancy and other adverse events related to the use of monoclonal antibodies in UC patients.
生物制剂对溃疡性结肠炎(UC)有效。目前,3种抗TNF药物(英夫利昔单抗、阿达木单抗和戈利木单抗)和1种抗整合素药物(维多珠单抗)被批准用于治疗UC。生物制剂的作用机制也可能引发多种副作用,有些甚至很严重。生物治疗在多大程度上可能与感染率、恶性肿瘤及其他不良事件的增加相关仍不确定。涵盖领域:我们的目的是回顾文献中的相关数据,并简要总结UC生物治疗的安全性概况。我们使用OVID、MEDLINE、PUBMED和EMBASE数据库进行了文献检索。还使用了其他相关的安全数据来源。专家意见:目前用于UC的所有生物制剂相对安全。强烈建议在开始此类治疗前采取准确的预防措施和筛查,并进行定期监测,以将UC患者中与使用单克隆抗体相关的感染、恶性肿瘤及其他不良事件的风险降至最低。