University of Chicago Inflammatory Bowel Disease Center, Chicago, Illinois 60637, USA.
Inflamm Bowel Dis. 2012 Dec;18(12):2225-31. doi: 10.1002/ibd.22925. Epub 2012 Feb 22.
Anti-tumor necrosis factor (TNF) therapy is an important treatment option for management of active Crohn's disease (CD) and is labeled for use after failure of conventional therapy (step-up). However, there is debate on the introduction of anti-TNF agents earlier in the treatment strategy (top-down) to potentially improve clinical outcomes. The aim of this study was to determine if a top-down approach with anti-TNF therapy is associated with improved outcomes for patients with active CD.
Claims data were from adult patients with CD with continuous enrollment in the same health plan for ≥ 6 months prior to the initial diagnostic claim for CD, ≥ 12 months after their initial anti-TNF claim, and with ≥ 1 anti-TNF claims after their initial diagnosis for CD.
Three patient groups were identified: The Step-Up group used 5-aminosalicylates and/or corticosteroids prior to anti-TNF; the immunosuppression (IS)-to-TNF inhibitor group used IS prior to anti-TNF therapy; the Early-TNF group initiated anti-TNF therapy within 30 days of the first prescription for CD. Response to anti-TNF therapy was determined up to 24 months following anti-TNF initiation by concomitant corticosteroid use, CD surgery, anti-TNF dose escalation, and anti-TNF discontinuation/switch. A top-down approach to anti-TNF therapy was associated with a lower risk of concomitant corticosteroid use, anti-TNF dose escalation, discontinuation/switch of anti-TNF, and CD-related surgery compared with the step-up and IS-to-TNF therapy approaches.
These "real-world" data show that a top-down approach to anti-TNF therapy in CD is associated with reductions in loss of response and fewer surgeries than conventional step-wise management.
抗肿瘤坏死因子(TNF)治疗是治疗活动期克罗恩病(CD)的重要选择,适用于常规治疗失败后(逐步升级)。然而,关于在治疗策略中更早引入抗 TNF 药物(自上而下)以潜在改善临床结果存在争议。本研究旨在确定针对活动期 CD 患者,采用抗 TNF 药物的自上而下方法是否与改善结局相关。
索赔数据来自 CD 成年患者,在首次诊断为 CD 的初始诊断索赔前至少有 6 个月、在首次抗 TNF 索赔后至少 12 个月、在首次诊断 CD 后至少有 1 次抗 TNF 索赔的情况下,连续参加同一健康计划。
确定了 3 组患者:逐步升级组在使用抗 TNF 之前使用了 5-氨基水杨酸和/或皮质类固醇;免疫抑制(IS)至 TNF 抑制剂组在使用抗 TNF 治疗之前使用了 IS;早期 TNF 组在首次开具 CD 处方后的 30 天内开始使用抗 TNF 治疗。在抗 TNF 治疗开始后最多 24 个月,通过同时使用皮质类固醇、CD 手术、抗 TNF 剂量升级以及抗 TNF 停药/换药来确定对抗 TNF 治疗的反应。与逐步升级和 IS 至 TNF 治疗方法相比,抗 TNF 治疗的自上而下方法与降低同时使用皮质类固醇、抗 TNF 剂量升级、抗 TNF 停药/换药以及 CD 相关手术的风险相关。
这些“真实世界”数据表明,在 CD 中采用抗 TNF 治疗的自上而下方法与常规逐步管理相比,可降低治疗失败的风险并减少手术。