Analysis Group, Inc., Montreal, QC, Canada.
Janssen Scientific Affairs, LLC, Horsham, PA.
J Manag Care Spec Pharm. 2023 Aug;29(8):907-916. doi: 10.18553/jmcp.2023.29.8.907.
Real-world data on persistence on ustekinumab and adalimumab among bio-experienced patients with Crohn's disease (CD) are limited. To compare treatment persistence and describe switching, restart, and dose titration among bio-experienced patients with CD initiated on ustekinumab or adalimumab. IBM MarketScan Commercial Database was used to identify bio-experienced adults with CD who were assigned to either the ustekinumab or adalimumab cohort based on the agent first initiated (index date) after September 23, 2016. Cohorts were balanced using inverse probability of treatment weights-average treatment effect on treated. Persistence on index agent (absence of exposure gap > 120 days for ustekinumab or > 60 days for adalimumab), persistence while corticosteroid-free, and persistence while receiving monotherapy were assessed at 12 months after index date and compared between cohorts using weighted Kaplan-Meier and Cox proportional hazards model analyses. Among 903 patients in the ustekinumab cohort and 525 patients in the adalimumab cohort, baseline characteristics were balanced after weighting. At 12 months post-index, ustekinumab was associated with higher persistence (80.1% vs 64.6%; hazard ratio = 2.02 [95% CI = 1.60-2.56]; < 0.001) and persistence while receiving monotherapy (51.6% vs 40.0%; 1.51 [1.28-1.78]; < 0.001) vs adalimumab. Persistence while corticosteroid-free was similar in the ustekinumab vs adalimumab cohort (50.1% vs 48.2%; 1.19 [1.00-1.41]; = 0.0516). This retrospective real-world study demonstrated that among bio-experienced patients with CD, initiation of ustekinumab was associated with better persistence at 12 months of follow-up, including persistence while receiving monotherapy, compared with adalimumab. This study was funded by Janssen Scientific Affairs, LLC. Drs Zhao, Ding, and Kachroo are employees of Janssen Scientific Affairs, LLC, and stockholders of Johnson & Johnson. Dr Manceur, Mr Lefebvre, Ms Zhdanava, and Mr Pilon are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and article. Mr Holiday was an employee of Analysis Group, Inc., at the time of study conduct.
在有生物治疗经验的克罗恩病（CD）患者中，乌司奴单抗和阿达木单抗持续治疗的数据有限。本研究旨在比较有生物治疗经验的 CD 患者接受乌司奴单抗或阿达木单抗治疗的持续治疗情况，并描述其药物转换、重新开始治疗和剂量滴定情况。研究使用 IBM MarketScan 商业数据库，纳入 2016 年 9 月 23 日后首次使用乌司奴单抗或阿达木单抗（索引日期）的有生物治疗经验的 CD 成年患者，根据治疗药物将其分配到乌司奴单抗或阿达木单抗队列中。采用逆概率治疗加权平均治疗效果（average treatment effect on treated，ATE）平衡两组患者。在索引日期后 12 个月，评估并比较两组患者索引药物的持续治疗（乌司奴单抗无暴露间隔>120 天，阿达木单抗无暴露间隔>60 天）、无皮质类固醇激素治疗持续时间和单药治疗持续时间，并使用加权 Kaplan-Meier 和 Cox 比例风险模型分析进行比较。在乌司奴单抗队列的 903 例患者和阿达木单抗队列的 525 例患者中，加权后基线特征平衡。在索引后 12 个月时，乌司奴单抗治疗的持续时间（80.1% vs. 64.6%；风险比[hazard ratio，HR]=2.02[95%置信区间[confidence interval，CI]：1.60-2.56]；<0.001）和单药治疗持续时间（51.6% vs. 40.0%；1.51[1.28-1.78]；<0.001）均高于阿达木单抗。乌司奴单抗和阿达木单抗组无皮质类固醇激素治疗的持续时间相似（50.1% vs. 48.2%；1.19[1.00-1.41]；=0.0516）。本回顾性真实世界研究表明，在有生物治疗经验的 CD 患者中，与阿达木单抗相比，乌司奴单抗治疗的 12 个月随访时的持续治疗效果更好，包括单药治疗的持续时间。本研究由 Janssen Scientific Affairs，LLC 资助。Zhao 博士、Ding 博士、Kachroo 博士为 Janssen Scientific Affairs，LLC 的员工，同时也是 Johnson & Johnson 的股东。Manceur 博士、Lefebvre 先生、Zhdanova 女士和 Pilon 先生为 Analysis Group，Inc.的员工，Analysis Group，Inc. 是一家咨询公司，曾为 Janssen Scientific Affairs，LLC 提供有偿咨询服务，该公司为这项研究和文章的开展提供了资金支持。Holiday 先生在研究进行期间为 Analysis Group，Inc.的员工。
