背景:溃疡性结肠炎(UC)的高级疗法的持久性是一种有用的现实世界治疗性能衡量标准。这项研究比较了接受ustekinumab或阿达木单抗治疗的早期和有经验的UC患者在维持阶段的真实世界持久性。
方法:使用IQVIAPharMetrics®Plus去识别数据库(2015年01月01日-2022年06月30日)中的索赔数据,根据2019年10月21日之后首次开始使用的药物(索引日期)选择接受ustekinumab或阿达木单抗治疗的成年UC患者。使用治疗加权的逆概率来平衡基线特征的队列。指标药物的持久性(ustekinumab的供应天数>120天或阿达木单抗的供应天数>60天没有缺口),不含皮质类固醇的持久性,在单药治疗时,使用Kaplan-Meier分析和Cox比例风险模型,在12个月期间描述和比较了US标记剂量的持久性.分别分析了早期晚期治疗和有晚期治疗经验的患者的结果。
结果:索引后12个月,接受ustekinumab(n=371)的晚期治疗初治患者对指数药物的持久性更高[83.8%vs.57.6%,风险比(95%置信区间)=3.09(2.29-4.16);p<0.001),无皮质类固醇时的持久性[2.00(1.63-2.45);p<0.001],单药治疗时的持久性[2.67(2.07-3.44);p<0.001],与接受阿达木单抗的剂量(n=1726)相比,标记剂量的持久性[4.21(2.76-6.44);p<0.001]。在指数后的12个月,接受ustekinumab(n=693)的晚期治疗经验患者对指数药物的持久性更高[78.1%vs.59.2%,2.44(1.82-3.26);p<0.001],无皮质类固醇时的持久性[1.24(1.01-1.54);p=0.0447],单药治疗时的持久性[2.53(2.00-3.21);p<0.001],和持续的标记剂量[4.77(3.09-7.35);p<0.001]与那些接受阿达木单抗(n=254)。
结论:这项基于索赔的分析表明,治疗持久性明显更高,包括不含皮质类固醇的持久性,单药治疗时的持久性,以及标记剂量的持久性,与阿达木单抗相比,在接受ustekinumab治疗的UC患者中,首次接受和接受过晚期治疗的UC患者均接受晚期治疗.
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.