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与英夫利昔单抗治疗失败的克罗恩病患者强化剂量治疗相比,个体化治疗是一种长期具有成本效益的方法。

Individualized Therapy Is a Long-Term Cost-Effective Method Compared to Dose Intensification in Crohn's Disease Patients Failing Infliximab.

作者信息

Steenholdt Casper, Brynskov Jørn, Thomsen Ole Ø, Munck Lars K, Fallingborg Jan, Christensen Lisbet A, Pedersen Gitte, Kjeldsen Jens, Jacobsen Bent A, Oxholm Anne Sophie, Kjellberg Jakob, Bendtzen Klaus, Ainsworth Mark A

机构信息

Department of Gastroenterology, Herlev Hospital, Herlev Ringvej 75, 2730, Herlev, Denmark,

出版信息

Dig Dis Sci. 2015 Sep;60(9):2762-70. doi: 10.1007/s10620-015-3581-4. Epub 2015 Feb 12.

Abstract

BACKGROUND

In Crohn's disease patients failing infliximab therapy, interventions defined by an algorithm based on infliximab and anti-infliximab antibody measurements have proven more cost-effective than intensifying the infliximab regimen.

AIM

This study investigated long-term economic outcomes at the week 20 follow-up study visit and after 1 year. Clinical outcomes were assessed at week 20.

METHODS

Follow-up from a 12-week, single-blind, clinical trial where patients with infliximab treatment failure were randomized to infliximab intensification (5 mg/kg every 4 weeks) (n = 36), or algorithm-defined interventions (n = 33). Accumulated costs, expressed as mean costs per patient, were based on the Danish National Patient Registry.

RESULTS

At the scheduled week 20 follow-up study visit, response and remission rates were similar in all study subpopulations between patients treated by the algorithm or by infliximab intensification. However, the sum of healthcare costs related to Crohn's disease was substantially lower (31 %) for patients randomized to algorithm-based interventions than infliximab intensification in the intention-to-treat population: $11,940 versus $17,236; p = 0.005. For per-protocol patients (n = 55), costs at the week 20 follow-up visit were even lower (49 %) in the algorithm group: $8,742 versus $17,236; p = 0.002. Figures were similar for patients having completed the 12-week trial as per protocol (50 % reduction in costs) (n = 45). Among patients continuing the allocated study intervention throughout the entire 20-week follow-up period (n = 29), costs were reduced by 60 % in algorithm-treated patients: $7,056 versus $17,776; p < 0.001. Cost-reduction percentages remained stable throughout one year.

CONCLUSION

Economic benefit of algorithm-based interventions at infliximab failure is maintained throughout 1 year.

摘要

背景

在英夫利昔单抗治疗失败的克罗恩病患者中,基于英夫利昔单抗和抗英夫利昔单抗抗体测量的算法所定义的干预措施已被证明比强化英夫利昔单抗治疗方案更具成本效益。

目的

本研究在第20周随访研究访视时以及1年后调查长期经济结果。在第20周评估临床结果。

方法

来自一项为期12周的单盲临床试验的随访,在该试验中,英夫利昔单抗治疗失败的患者被随机分为英夫利昔单抗强化治疗组(每4周5 mg/kg)(n = 36)或算法定义的干预措施组(n = 33)。累积成本以每位患者的平均成本表示,基于丹麦国家患者登记处的数据。

结果

在预定的第20周随访研究访视时,算法治疗患者与英夫利昔单抗强化治疗患者的所有研究亚组中的缓解率和应答率相似。然而,在意向性治疗人群中,随机接受基于算法干预措施的患者与英夫利昔单抗强化治疗患者相比,与克罗恩病相关的医疗保健成本总和显著更低(31%):11,940美元对17,236美元;p = 0.005。对于符合方案的患者(n = 55),在第20周随访访视时,算法组的成本甚至更低(49%):8,742美元对17,236美元;p = 0.002。按照方案完成12周试验的患者(成本降低50%)(n = 45)的情况相似。在整个20周随访期内持续接受分配的研究干预措施的患者中(n = 29),算法治疗患者的成本降低了60%:7,056美元对17,776美元;p < 0.001。成本降低百分比在一整年中保持稳定。

结论

英夫利昔单抗治疗失败时基于算法的干预措施的经济效益在1年内持续存在。

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