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溃疡性结肠炎患者中曾使用抗肿瘤坏死因子药物,转而使用不同作用方式的生物制剂或换用另一种抗肿瘤坏死因子药物后的治疗持续性。

Treatment Persistence Among Anti-Tumor Necrosis Factor-experienced Patients With Ulcerative Colitis Switching to a Biologic With a Different Mode of Action or Cycling to Another Anti-Tumor Necrosis Factor Agent.

作者信息

Zhdanava Maryia, Burbage Sabree, Boonmak Porpong, Kachroo Sumesh, Shah Aditi, Godwin Bridget, Pilon Dominic

机构信息

Analysis Group, Inc, Montreal, Quebec, Canada.

Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.

出版信息

Clin Ther. 2025 Mar;47(3):204-211. doi: 10.1016/j.clinthera.2024.12.002. Epub 2024 Dec 31.

Abstract

PURPOSE

In ulcerative colitis (UC), anti-tumor necrosis factor (TNF) agents often are first-line biologic therapy. Switching to a biologic with a different mode of action (ustekinumab and vedolizumab) or cycling to another anti-TNF agent (adalimumab, infliximab, and golimumab) is necessary if an initial anti-TNF fails. This study compared real-world persistence in patients with UC who switched to a biologic with a different mode of action or cycled with another anti-TNF after nonresponse to an anti-TNF.

METHODS

Adults with UC treated with an anti-TNF, who switched or cycled (index date) between October 21, 2019, and March 02, 2022, were selected from the IQVIA PharMetrics® Plus database. Patients had ≥12 months of continuous insurance eligibility before the first anti-TNF without UC-indicated biologics or advanced therapies. During the 12 months before the index date (baseline period), patients had no other immune disorders and discontinued the first anti-TNF. Baseline characteristics were balanced using inverse probability of treatment weights. Persistence on the index biologic was defined as no therapy exposure gaps >120 days (ustekinumab, vedolizumab, and infliximab) or >60 days (adalimumab and golimumab) between days of supply. Composite end points were persistence while corticosteroid-free (<14 consecutive days of corticosteroid supply after day 90 post-index) and persistence while on monotherapy (no immunomodulators/nonindex biologics/advanced therapies). End points were assessed with weighted Kaplan-Meier and Cox proportional hazards models 12 months after the maintenance phase started.

FINDINGS

The switch cohort included 488 patients (mean age: 41.4 years; 44.9% female), and the cycle cohort included 129 patients (mean age: 40.7 years; 43.8% female). At 12 months after the maintenance phase started, the proportions of persistent patients (switch cohort: 79.6%; cycle cohort: 64.9%) and persistent patients on monotherapy (switch cohort: 74.6%; cycle cohort: 48.0%) were significantly higher in the switch versus cycle cohort; the proportions of persistent patients while corticosteroid-free was also higher in the switch (60.1%) versus cycle cohort (49.3%) but was not significant. In the switch cohort, the rate of persistence was 1.92 times higher (hazard ratio [HR] = 1.92; 95% CI, 1.31-2.82), the rate of persistence while on monotherapy was 2.56 times higher (HR = 2.56; 95% CI, 1.86-3.53), and the rate of persistence and being corticosteroid-free was 1.31 times higher (HR = 1.31; 95% CI, 0.98-1.77) than in the cycle cohort.

IMPLICATIONS

Patients with UC who switched from an anti-TNF agent to a biologic with a different mode of action were more persistent on treatment than patients who cycled to another anti-TNF agent. Findings may aid physicians whose patients experience treatment failure on the first anti-TNF agent.

摘要

目的

在溃疡性结肠炎(UC)中,抗肿瘤坏死因子(TNF)药物通常是一线生物治疗药物。如果初始抗TNF治疗失败,则有必要换用具有不同作用方式的生物制剂(优特克单抗和维多珠单抗)或换用另一种抗TNF药物(阿达木单抗、英夫利昔单抗和戈利木单抗)。本研究比较了UC患者在抗TNF治疗无反应后换用不同作用方式的生物制剂或换用另一种抗TNF药物后的实际治疗持续时间。

方法

从IQVIA PharMetrics® Plus数据库中选取2019年10月21日至2022年3月2日期间接受抗TNF治疗并进行了换药或换用(索引日期)的成年UC患者。患者在首次使用抗TNF药物之前有≥12个月的连续保险资格,且未使用UC指定的生物制剂或先进疗法。在索引日期前的12个月(基线期),患者无其他免疫疾病且停用了第一种抗TNF药物。使用治疗权重的逆概率对基线特征进行平衡。索引生物制剂的治疗持续时间定义为供应日之间无>120天(优特克单抗、维多珠单抗和英夫利昔单抗)或>60天(阿达木单抗和戈利木单抗)的治疗暴露间隙。复合终点为无糖皮质激素治疗时的持续时间(索引日期后90天内糖皮质激素供应连续<14天)和单药治疗时的持续时间(无免疫调节剂/非索引生物制剂/先进疗法)。在维持期开始12个月后,使用加权Kaplan-Meier和Cox比例风险模型评估终点。

结果

换药队列包括488例患者(平均年龄:41.4岁;44.9%为女性),换用队列包括129例患者(平均年龄:40.7岁;43.8%为女性)。在维持期开始12个月后,换药队列中持续治疗患者的比例(79.6%)和单药治疗持续患者的比例(74.6%)显著高于换用队列(分别为64.9%和48.0%);换药队列中无糖皮质激素治疗时持续患者的比例(60.1%)也高于换用队列(49.3%),但差异无统计学意义。在换药队列中,持续治疗率高1.92倍(风险比[HR]=1.92;95%置信区间,1.31-2.82),单药治疗时的持续治疗率高2.56倍(HR=2.56;95%置信区间,1.86-3.53),无糖皮质激素治疗时的持续治疗率高1.31倍(HR=1.31;95%置信区间,0.98-1.77)。

结论

从抗TNF药物换用不同作用方式生物制剂的UC患者比换用另一种抗TNF药物的患者治疗持续性更强。这些发现可能有助于那些患者在第一种抗TNF药物治疗失败的医生。

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