Analysis Group, Inc., 1190 Avenue Des Canadiens-de-Montréal, Suite 1500, Montreal, QC, Canada.
Janssen Scientific Affairs, LLC, a Johnson & Johnson Company, 800 Ridgeview Drive, Horsham, PA, USA.
Adv Ther. 2024 Oct;41(10):3868-3887. doi: 10.1007/s12325-024-02942-6. Epub 2024 Aug 14.
Persistence on advanced therapies in ulcerative colitis (UC) is a useful real-world treatment performance measure. This study compared real-world persistence during the maintenance phase among advanced therapy-naïve and -experienced patients with UC initiated on ustekinumab or adalimumab.
Claims data from the IQVIA PharMetrics Plus de-identified database (01/01/2015-06/30/2022) were used to select adult patients with UC treated with ustekinumab or adalimumab based on the agent first initiated (index date) after 10/21/2019. Inverse probability of treatment weighting was used to balance cohorts on baseline characteristics. Persistence on the index agent (no gaps in days of supply of > 120 days for ustekinumab or > 60 days for adalimumab), persistence while corticosteroid-free, while on monotherapy, and persistence on the US labeled dose were described and compared during the 12-month period post-index using Kaplan-Meier analysis and Cox proportional hazards models. Outcomes were analyzed separately among advanced therapy-naïve and advanced therapy-experienced patients.
At 12 months post-index, advanced therapy-naïve patients receiving ustekinumab (n = 371) had higher persistence on the index agent [83.8% vs. 57.6%, hazard ratio (95% confidence interval) = 3.09 (2.29-4.16); p < 0.001), persistence while corticosteroid-free [2.00 (1.63-2.45); p < 0.001], persistence while on monotherapy [2.67 (2.07-3.44); p < 0.001], and persistence on the labeled dose [4.21 (2.76-6.44); p < 0.001] versus those receiving adalimumab (n = 1726). At 12 months post-index, advanced therapy-experienced patients receiving ustekinumab (n = 693) had higher persistence on the index agent [78.1% vs. 59.2%, 2.44 (1.82-3.26); p < 0.001], persistence while corticosteroid-free [1.24 (1.01-1.54); p = 0.0447], persistence while on monotherapy [2.53 (2.00-3.21); p < 0.001], and persistence on the labeled dose [4.77 (3.09-7.35); p < 0.001] versus those receiving adalimumab (n = 254).
This claims-based analysis demonstrated significantly higher treatment persistence, including persistence while corticosteroid-free, persistence while on monotherapy, and persistence on the labeled dose, among both advanced therapy-naïve and advanced therapy-experienced patients with UC initiated on ustekinumab compared to adalimumab.
在溃疡性结肠炎（UC）中坚持使用高级治疗是一种有用的真实世界治疗效果衡量标准。本研究比较了在接受乌司奴单抗或阿达木单抗治疗的 UC 初治和经验丰富的患者中，在维持期的真实世界坚持治疗情况。
本研究使用 IQVIA PharMetrics Plus 去标识数据库（2015 年 10 月 21 日至 2022 年 6 月 30 日）中的索赔数据，根据在 2019 年 10 月 21 日后首次使用的药物（索引日期），选择接受乌司奴单抗或阿达木单抗治疗的 UC 成年患者。采用逆概率治疗加权法（inverse probability of treatment weighting）对基线特征进行平衡。在索引药物（乌司奴单抗的供应天数无间隙> 120 天，阿达木单抗> 60 天）、无皮质激素期间的坚持治疗、单药治疗期间的坚持治疗以及使用美国标签剂量的坚持治疗方面进行描述，并在索引后 12 个月内使用 Kaplan-Meier 分析和 Cox 比例风险模型进行比较。在初治和经验丰富的高级治疗患者中分别进行结果分析。
在索引后 12 个月，接受乌司奴单抗治疗的初治患者（n = 371）在索引药物的坚持治疗率更高[83.8% vs. 57.6%，风险比（95%置信区间）= 3.09（2.29-4.16）；p < 0.001]、无皮质激素期间的坚持治疗率[2.00（1.63-2.45）；p < 0.001]、单药治疗期间的坚持治疗率[2.67（2.07-3.44）；p < 0.001]和标签剂量的坚持治疗率[4.21（2.76-6.44）；p < 0.001]均高于接受阿达木单抗治疗的患者（n = 1726）。在索引后 12 个月，接受乌司奴单抗治疗的经验丰富的高级治疗患者（n = 693）在索引药物的坚持治疗率更高[78.1% vs. 59.2%，2.44（1.82-3.26）；p < 0.001]、无皮质激素期间的坚持治疗率[1.24（1.01-1.54）；p = 0.0447]、单药治疗期间的坚持治疗率[2.53（2.00-3.21）；p < 0.001]和标签剂量的坚持治疗率[4.77（3.09-7.35）；p < 0.001]均高于接受阿达木单抗治疗的患者（n = 254）。
这项基于索赔的分析表明，在接受乌司奴单抗治疗的初治和经验丰富的 UC 患者中，与接受阿达木单抗治疗的患者相比，治疗坚持率更高，包括无皮质激素期间的坚持治疗、单药治疗期间的坚持治疗以及标签剂量的坚持治疗。
