■生物制剂已证明在治疗溃疡性结肠炎(UC)中有效;然而,肿瘤坏死因子抑制剂(TNFi)治疗失败在现实世界中很常见。失败后临床实践中的优先测序数据仍然有限。
■本研究旨在评估患者循环到TNFis或在TNFis一线失败后转换到非TNFi生物制剂的真实世界结果。
■德国的回顾性队列研究。
■使用由法定疾病基金提供的2014年5月1日至2022年6月30日的行政索赔数据确定UC成年患者。确定了新开始使用TNF-α进行一线治疗然后转换为另一种药物的患者。患者被定义为类内转换(WCS),如果他们循环到另一个TNFi,或外部类切换器(OCS),如果他们改用非TNFi生物制剂[ustekinumab(UST)或vedolizumab(VDZ)]并从索引(转换日期)到死亡,保险端,或研究于2022年6月30日结束。进行治疗加权的逆概率(IPTW)以调整组间基线特征的差异,和加权Cox回归模型用于比较主要结局(停药时间和二次治疗转换时间)和次要结局(无皮质类固醇药物生存期).
■我们确定了166名开始肿瘤坏死因子并转换为后续治疗的患者(平均年龄:42.9岁,49.4%为女性)。在IPTW之后,WCS和OCS组分别有71和76名患者,分别。与OCS相比,WCS更有可能停止新疗法[风险比(HR),1.82,95%置信区间(CI),1.14-2.89,p=0.012],并第二次切换(HR,3.46,95%CI,1.89-6.36,p<0.001)。此外,WCS显示开始长期皮质类固醇治疗的可能性增加(HR,1.42,95%CI,0.77-2.59,p=0.260);然而,结果不显著。
■一线TNFi故障后,这项研究表明,当循环使用另一种TNFi时,UC患者的真实世界结果不太有利,与切换到非TNFi(如UST或VDZ)相比。
UNASSIGNED: Biologic agents have demonstrated efficacy in treating ulcerative colitis (UC); however, treatment failure to tumor necrosis factor inhibitors (TNFi) is common in the real world. Data on preferential sequencing in clinical practice after failure remain limited.
UNASSIGNED: This study aimed to evaluate real-world outcomes of patients cycling to TNFis or
switching to non-TNFi biologics following first-line failure with TNFis.
UNASSIGNED: Retrospective cohort study in Germany.
UNASSIGNED: Adult patients with UC were identified using administrative claims data from 1 May 2014 to 30 June 2022 provided by a statutory sickness fund. Patients newly initiating first-line therapy with TNFis and then
switching to another agent were identified. Patients were defined as within-class switched (WCS), if they cycled to another TNFi, or outside-class switchers (OCS), if they switched to a non-TNFi biologic [ustekinumab (UST) or vedolizumab (VDZ)] and followed from index (switch date) to death, insurance end, or study end on 30 June 2022. Inverse probability of treatment weighting (IPTW) was performed to adjust for differences in baseline characteristics between groups, and weighted Cox regression models were used to compare primary (time to discontinuation and second treatment switch) and secondary outcomes (corticosteroid-free drug survival).
UNASSIGNED: We identified 166 patients initiating TNFis and
switching to a subsequent treatment (mean age: 42.9 years, 49.4% female). Following IPTW, there were 71 and 76 patients in the WCS and OCS groups, respectively. Compared to OCS, WCS were more likely to discontinue the new therapy [hazard ratio (HR), 1.82, 95% confidence interval (CI), 1.14-2.89, p = 0.012], and switch a second time (HR, 3.46, 95% CI, 1.89-6.36, p < 0.001). Moreover, WCS showed an increased likelihood of initiating prolonged corticosteroid therapy (HR, 1.42, 95% CI, 0.77-2.59, p = 0.260); however, the results were not significant.
UNASSIGNED: Following first-line TNFi failure, this study suggests that real-world outcomes among patients with UC are less favorable when cycling to another TNFi, compared to
switching to a non-TNFi such as UST or VDZ.