Dragoni Gabriele, Le Grazie Marco, Orlandini Beatrice, Rogai Francesca
IBD Unit, Gastroenterology Department, Careggi Hospital, University of Florence, Viale San Luca, 50134, Florence, Italy.
Clin J Gastroenterol. 2019 Feb;12(1):1-9. doi: 10.1007/s12328-018-0906-9. Epub 2018 Sep 11.
Golimumab is the third anti-TNF agent approved for the treatment of ulcerative colitis. Despite initial success demonstrated by PURSUIT trials, only few real-life studies have been published evaluating its efficacy and safety in clinical practice. Its subcutaneous route and monthly administration represent an advantage in patient compliance, respectively, vs infliximab (intravenous) and adalimumab (two doses per month). The most important weakness of the molecule which often leads clinicians to choose another anti-TNF is the impossibility to dose escalate or reduce the frequency of administrations in case of secondary failure; ongoing studies are trying to solve this problem by monitoring drug levels and the eventual presence of neutralizing anti-drug antibodies. No advantage has still been demonstrated for combination therapy of golimumab with immunosuppressants and further studies are necessary to evaluate this aspect. Preliminary data also report golimumab efficacy in Crohn's disease with higher doses than in ulcerative colitis with an acceptable safety profile. Additional studies are needed in this field to confirm the initial findings.
戈利木单抗是第三种被批准用于治疗溃疡性结肠炎的抗肿瘤坏死因子（TNF）药物。尽管PURSUIT试验显示出初步成功，但仅有少数实际应用研究发表，评估其在临床实践中的疗效和安全性。与英夫利昔单抗（静脉注射）和阿达木单抗（每月两剂）相比，其皮下给药途径和每月一次给药分别在患者依从性方面具有优势。该药物分子最重要的缺点是在继发失效时无法增加剂量或减少给药频率，这常常导致临床医生选择另一种抗TNF药物；正在进行的研究试图通过监测药物水平和中和性抗药物抗体的最终存在情况来解决这个问题。戈利木单抗与免疫抑制剂联合治疗尚未显示出优势，需要进一步研究来评估这一方面。初步数据还报告了戈利木单抗在克罗恩病中的疗效，其剂量高于溃疡性结肠炎，且安全性可接受。该领域需要更多研究来证实初步研究结果。
