Center for Gastrointestinal Biology and Disease, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois, USA.
Dig Dis. 2022;40(5):553-564. doi: 10.1159/000521299. Epub 2021 Dec 8.
Biologic therapies are often used in patients with ulcerative colitis (UC) who are nonresponsive to conventional treatments. However, nonresponse or loss of response to biologics often occurs, leading to dose escalation, combination therapy, and/or treatment switching. We investigated real-world treatment patterns of biologic therapies among patients with UC in the USA.
This study analyzed data from the IBM® MarketScan® Commercial and Medicare Supplemental Databases (medical/pharmacy claims for >250 million patients in the USA) to identify patients with UC initiating a biologic therapy (adalimumab, infliximab, golimumab, or vedolizumab) with 12 months of follow-up post-initiation. Key measures were patient baseline characteristics, dose escalation (average maintenance dose >20% higher than label), adherence (proportion of days covered), and ulcerative colitis-related healthcare costs in the 12 months following biologic therapy initiation.
Of 2,331 patients included in the study (adalimumab [N = 1,291], infliximab [N = 810], golimumab [N = 127], and vedolizumab [N = 103]), 28.1% used concomitant immunosuppressant therapy within 12 months post-initiation. Overall, 23.6% (adalimumab), 34.8% (infliximab), 9.9% (golimumab), and 39.2% (vedolizumab) of patients dose escalated within 12 months. Patients who dose escalated incurred USD 20,106 higher total UC-related healthcare costs over 12 months than those who did not. Adherence (covariate-adjusted proportion of days covered) ranged from 0.63 to 0.73, and 39.3% of patients discontinued within 12 months (median treatment duration = 112 days).
Dose escalation was common, and incurred higher costs, in patients with UC initiating biologic therapies. Suboptimal adherence and/or discontinuation within 12 months of initiation occurred frequently, highlighting the challenges in managing these patients.
生物疗法常用于对常规治疗无反应的溃疡性结肠炎（UC）患者。然而，生物制剂常常会出现无应答或应答丧失，导致剂量升级、联合治疗和/或治疗转换。我们调查了美国 UC 患者中生物制剂的真实世界治疗模式。
本研究分析了 IBM® MarketScan®商业和补充医疗保险数据库（美国超过 2.5 亿患者的医疗/药房理赔数据）中的数据，以确定接受生物制剂（阿达木单抗、英夫利昔单抗、戈利木单抗或维得利珠单抗）治疗且治疗开始后有 12 个月随访的 UC 患者。主要观察指标为患者基线特征、剂量升级（平均维持剂量比标签高 20%以上）、依从性（覆盖率天数）和生物制剂治疗开始后 12 个月内与溃疡性结肠炎相关的医疗保健费用。
本研究纳入 2331 例患者（阿达木单抗[N=1291]、英夫利昔单抗[N=810]、戈利木单抗[N=127]和维得利珠单抗[N=103]），28.1%的患者在治疗开始后 12 个月内同时使用免疫抑制剂治疗。总体而言，23.6%（阿达木单抗）、34.8%（英夫利昔单抗）、9.9%（戈利木单抗）和 39.2%（维得利珠单抗）的患者在 12 个月内进行了剂量升级。与未进行剂量升级的患者相比，在 12 个月内进行剂量升级的患者的总 UC 相关医疗保健费用高出 20106 美元。依从性（调整协变量后的覆盖率天数）范围为 0.63 至 0.73，39.3%的患者在 12 个月内停药（中位治疗持续时间=112 天）。
在接受生物制剂治疗的 UC 患者中，剂量升级很常见，且会产生更高的成本。治疗开始后 12 个月内依从性差和/或停药的情况很常见，这突显了管理这些患者的挑战。
