Krugliak Cleveland Noa, Candela Ninfa, Carter John A, Kuharic Maja, Qian Joyce, Tang Zhaoli, Turpin Robin, Rubin David T
University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA.
Takeda Pharmaceuticals USA, Inc., Lexington, MA, USA.
Crohns Colitis 360. 2024 Oct 22;6(4):otae061. doi: 10.1093/crocol/otae061. eCollection 2024 Oct.
Patients with ulcerative colitis (UC) typically receive a targeted inflammatory bowel disease therapy after treatment with conventional therapies and after the development of significant morbidity. Evidence suggests that early biologic treatment after diagnosis could improve treatment response and prevent disease complications compared with delayed biologic treatment after conventional therapy.
RALEE was a retrospective study using claims data from IBM® MarketScan® Research Databases between January 1, 2016 and December 31, 2019. Adults with UC and at least one claim for vedolizumab were categorized into Early or Delayed Vedolizumab groups according to whether they had received vedolizumab within 30 days of diagnosis or after conventional therapy (5-aminosalicylates, corticosteroids, and immunomodulators), respectively. Treatment response was assessed at 2, 6, and 12 months after vedolizumab treatment initiation and was analyzed with logistic regression (bivariate).
At 2 months, Delayed Vedolizumab was associated with significantly higher odds of nonresponse than Early Vedolizumab (odds ratio [OR], 2.509; 95% confidence interval [CI], 1.28-4.90). Delayed Vedolizumab was not significantly associated with odds of nonresponse at 6 months (OR, 1.173; 95% CI, 0.72-1.90) or at 12 months (OR, 0.872; 95% CI, 0.55-1.37). Mean total healthcare costs were similar in the Early Vedolizumab ($6492) and Delayed Vedolizumab ($5897) groups, although there were small differences in costs from different types of claims.
Patients who received vedolizumab early after UC diagnosis were less likely to experience nonresponse at 2 months and incurred similar healthcare costs at 12 months compared with patients who received delayed vedolizumab.
溃疡性结肠炎（UC）患者在接受传统治疗且出现严重并发症后，通常会接受针对性的炎症性肠病治疗。有证据表明，与传统治疗后延迟使用生物制剂相比，诊断后早期使用生物制剂治疗可能会改善治疗反应并预防疾病并发症。
RALEE是一项回顾性研究，使用了2016年1月1日至2019年12月31日期间IBM® MarketScan®研究数据库中的索赔数据。患有UC且至少有一次维多珠单抗索赔记录的成年人，根据其在诊断后30天内或在传统治疗（5-氨基水杨酸类、皮质类固醇和免疫调节剂）后是否接受维多珠单抗，分别分为早期维多珠单抗组或延迟维多珠单抗组。在维多珠单抗治疗开始后的2、6和12个月评估治疗反应，并采用逻辑回归（双变量）进行分析。
在2个月时，延迟使用维多珠单抗组无反应的几率显著高于早期使用维多珠单抗组（优势比[OR]，2.509；95%置信区间[CI]，1.28 - 4.90）。延迟使用维多珠单抗组在6个月时（OR，1.173；95% CI，0.72 - 1.90）或12个月时（OR，0.872；95% CI，0.55 - 1.37）与无反应几率无显著关联。早期维多珠单抗组（6492美元）和延迟维多珠单抗组（5897美元）的平均总医疗费用相似，尽管不同类型索赔的费用存在细微差异。
与延迟使用维多珠单抗的患者相比，UC诊断后早期接受维多珠单抗治疗的患者在2个月时无反应的可能性较小，且在12个月时产生的医疗费用相似。
