Kedia Saurabh, Ahuja Vineet, Makharia Govind K
a Department of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
Expert Rev Clin Pharmacol. 2016 Oct;9(10):1273-82. doi: 10.1080/17512433.2016.1221759. Epub 2016 Aug 18.
Anti-TNF agents are the mainstay of therapy in patients with moderate to severe ulcerative colitis (UC) not responding to 5-aminosalisylic acid, corticosteroids, immunmodulators and for patients dependent on corticosteroids. There is a therapeutic gap of 30%- 60% with infliximab and adalimumab, which is required to be bridged by newer agents. The present review summarizes the literature on the role of golimumab, a new anti TNF agent, in ulcerative colitis.
Literature search was done on PubMed using the search terms 'golimumab' AND 'ulcerative colitis' from inception till March 2016. Golimumab, a fully human monoclonal antibody against TNF-α, was approved by FDA for clinical use in UC in 2013. In vitro studies showed golimumab to be better than infliximab and adalimumab in terms of affinity and neutralization of TNF-α and its conformational stability. Golimumab was found to be effective and safe in inducing and maintaining clinical remission, clinical response and mucosal healing in patients with UC in the two registration trials. Expert commentary: Although there is no difference in terms of efficacy between golimumab, infliximab and adalimumab, golimumab is better than infliximab in terms of route of administration (subcutaneous vs intravenous) and better than adalimumab in terms of frequency of dosing (4 weeks vs 2 weeks).
抗TNF药物是中重度溃疡性结肠炎(UC)患者治疗的主要手段,这些患者对5-氨基水杨酸、皮质类固醇、免疫调节剂无反应或依赖皮质类固醇。英夫利昔单抗和阿达木单抗存在30%-60%的治疗差距,需要更新的药物来弥补。本综述总结了新型抗TNF药物戈利木单抗在溃疡性结肠炎中作用的相关文献。
从创刊至2016年3月,在PubMed上使用搜索词“戈利木单抗”和“溃疡性结肠炎”进行文献检索。戈利木单抗是一种完全人源化的抗TNF-α单克隆抗体,2013年被美国食品药品监督管理局批准用于UC的临床治疗。体外研究表明,在TNF-α的亲和力、中和作用及其构象稳定性方面,戈利木单抗优于英夫利昔单抗和阿达木单抗。在两项注册试验中,发现戈利木单抗在诱导和维持UC患者的临床缓解、临床反应和黏膜愈合方面有效且安全。专家评论:虽然戈利木单抗、英夫利昔单抗和阿达木单抗在疗效方面没有差异,但戈利木单抗在给药途径(皮下注射与静脉注射)方面优于英夫利昔单抗,在给药频率(4周与2周)方面优于阿达木单抗。