Department of Hospital Pharmacy, Hospital General Universitario Reina Sofía, 30003, Murcia, Spain.
Department of Public Health, University of Murcia, Murcia, Spain.
Int J Clin Pharm. 2020 Apr;42(2):500-507. doi: 10.1007/s11096-020-00978-6. Epub 2020 Jan 31.
Background Conventional therapy of inflammatory bowel disease with traditional immunosuppressant medication is increasingly being replaced by biological agents. However, the response to these biological agents may be lost over time, with discontinuation being a marker of loss of effectiveness. There are few published reports on the treatment drug survival of infliximab and adalimumab in patients with inflammatory bowel disease. Objective This study compared the drug survival of infliximab versus adalimumab as first- and second-line treatments, identified factors associated with drug survival, and described reasons for treatment withdrawal. Setting A pharmacy department of a university hospital in Spain. Method A retrospective single-centre cohort study of all patients with inflammatory bowel disease treated with biological agents between 2008 and 2017 at a regional referral hospital. The primary outcome was drug survival and associated factors during a follow-up of 52 months. Main outcome measure Drug survival of infliximab versus adalimumab. Results One hundred thirty-four patients with inflammatory bowel disease (73.9% Crohn's disease and 26.1% ulcerative colitis) were treated with biological therapy. The overall mean drug survival of first-line treatment with an anti-tumour necrosis factor agent was 18.6 months (SD 14.9), with mean values of 20.2 months (SD 16.6) for adalimumab and 17.1 months (SD 13.1) for infliximab. As a second-line treatment, the drug survival of anti-tumour necrosis factor agents was 17.9 months (SD 15.6), with mean values of 22.9 months (SD 17.1) for adalimumab and 12.5 months (SD 11.7) for infliximab. The difference in time to discontinuation at 52 months of follow-up between the infliximab and adalimumab subgroups, as either first- or second-line treatment, was not statistically significant (p = 0.547 and p = 0.676, respectively). Therapeutic drug monitoring was the only factor associated with greater drug survival in first-line treatment (HR 0.27; 95% confidence interval, CI 0.15-0.50) and second-line treatment (HR 0.26; 95% CI 0.10-0.65). Secondary failure to treatment was the most frequent reason for withdrawal. Conclusion Infliximab and adalimumab showed similar drug survival as first- and second-line anti-tumour necrosis factor treatments. Therapeutic drug monitoring was associated with higher drug survival for both first- and second-line anti-tumour necrosis factor treatments.
传统免疫抑制剂药物的炎症性肠病常规治疗正逐渐被生物制剂所取代。然而，这些生物制剂的疗效可能会随时间而丧失，停药是疗效丧失的标志。关于炎症性肠病患者接受英夫利昔单抗和阿达木单抗治疗的药物生存情况，发表的报告很少。
本研究比较了英夫利昔单抗与阿达木单抗作为一线和二线治疗的药物生存情况，确定了与药物生存相关的因素，并描述了停药的原因。
西班牙一家大学医院的药剂科。
这是一项回顾性单中心队列研究，纳入了 2008 年至 2017 年在一家地区转诊医院接受生物制剂治疗的所有炎症性肠病患者。主要结局是在 52 个月的随访期间药物生存情况及其相关因素。
英夫利昔单抗与阿达木单抗的药物生存情况。
本研究纳入了 134 名炎症性肠病患者（73.9%为克罗恩病，26.1%为溃疡性结肠炎），接受了生物治疗。一线使用抗肿瘤坏死因子药物的总体平均药物生存时间为 18.6 个月（SD 14.9），阿达木单抗的平均药物生存时间为 20.2 个月（SD 16.6），英夫利昔单抗的平均药物生存时间为 17.1 个月（SD 13.1）。作为二线治疗，抗肿瘤坏死因子药物的药物生存时间为 17.9 个月（SD 15.6），阿达木单抗的平均药物生存时间为 22.9 个月（SD 17.1），英夫利昔单抗的平均药物生存时间为 12.5 个月（SD 11.7）。在 52 个月的随访中，英夫利昔单抗和阿达木单抗亚组（无论是一线还是二线治疗）停药时间的差异无统计学意义（分别为 p=0.547 和 p=0.676）。一线治疗中，治疗药物监测是唯一与药物生存时间延长相关的因素（HR 0.27；95%置信区间，CI 0.15-0.50），二线治疗中，治疗药物监测也是唯一与药物生存时间延长相关的因素（HR 0.26；95%CI 0.10-0.65）。治疗失败是最常见的停药原因。
英夫利昔单抗和阿达木单抗作为一线和二线抗肿瘤坏死因子治疗药物的药物生存情况相似。治疗药物监测与一线和二线抗肿瘤坏死因子治疗药物的更高药物生存情况相关。
