Zhdanava Maryia, Burbage Sabree, Boonmak Porpong, Kachroo Sumesh, Shah Aditi, Godwin Bridget, Pilon Dominic
Analysis Group, Inc, Montreal, Quebec, Canada.
Janssen Scientific Affairs, LLC, Horsham, Pennsylvania.
Clin Ther. 2025 Mar;47(3):204-211. doi: 10.1016/j.clinthera.2024.12.002. Epub 2024 Dec 31.
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.
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.
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.
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.
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。
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。
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)。
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。