阿巴西普或英夫利昔单抗治疗甲氨蝶呤治疗应答不佳的类风湿关节炎患者：一项意大利基于试验和真实世界的成本-效果分析。

Abatacept or infliximab for patients with rheumatoid arthritis and inadequate response to methotrexate: an Italian trial-based and real-life cost-consequence analysis.

机构信息

Department of Internal Medicine, Hospital San Giovanni di Dio, Florence, Italy.

出版信息

Clin Exp Rheumatol. 2013 Jul-Aug;31(4):575-83. Epub 2013 May 27.

Abstract

OBJECTIVES

In the 1-year, double-blind, placebo-controlled ATTEST trial, efficacy of abatacept or infliximab versus placebo was reported in patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). The current study estimated trial-based and real-life costs of abatacept and infliximab for achieving pre-defined remission or low disease activity state (LDAS).

METHODS

Quantity of drug, serious adverse event (SAE) rates and time (months) in remission or LDAS were taken from ATTEST for the trial-based calculation to derive a cost per remitting/LDAS patient and a cost per patient-month in remission/LDAS. Trial-based and real-life scenarios were performed.

RESULTS

The annual trial-based costs per remitting/LDAS patient were €70.238/€37.208 for abatacept and €85.565/€46.602 for infliximab. In the first 6 months of the ATTEST trial, costs per patient-month in remission/LDAS were higher for abatacept (€11.024 and €6.018, respectively), relative to infliximab (€8.347 and €4.174, respectively). Over the full 12-month trial period cost per month in remission/LDAS estimates were only slightly in favour of infliximab (€6.959/€3.625) relative to abatacept (€7.297/€3.909). Assuming extension of treatment under real life conditions the cost per month in remission/LDAS turned substantially in favour of abatacept (€5.321/€2.819), as compared to infliximab (€7.189/€3.916). The higher initiation cost for abatacept to achieve remission/LDAS would be offset after a total 14.6 and 16.1 months of treatment, respectively, if treatment extended beyond 6 months under real-life conditions. These results proved to be robust when it was assumed that the (i) sharing of vials across patients completely averted infliximab wastage, (ii) AE risks were similar and (iii) onset of response was slower for abatacept.

CONCLUSIONS

Our findings suggest a lower cost-consequence for abatacept during real-life treatment.

摘要

目的

在为期 1 年、双盲、安慰剂对照的 ATTET 试验中，报告了阿巴西普或英夫利昔单抗与安慰剂相比在对甲氨蝶呤（MTX）反应不足的类风湿关节炎（RA）患者中的疗效。本研究评估了阿巴西普和英夫利昔单抗达到预先设定的缓解或低疾病活动状态（LDAS）的试验和实际成本。

方法

从 ATTET 中获取药物数量、严重不良事件（SAE）发生率和缓解/低疾病活动状态持续时间（月），以进行基于试验的计算，得出每位缓解/低疾病活动状态患者的成本和每位缓解/低疾病活动状态患者的月成本。进行了基于试验和实际情况的分析。

结果

基于试验的每位缓解/低疾病活动状态患者的年度成本分别为阿巴西普 70238 欧元和英夫利昔单抗 37208 欧元，阿巴西普 85565 欧元和英夫利昔单抗 46602 欧元。在 ATTET 试验的前 6 个月，阿巴西普的缓解/低疾病活动状态患者的每月成本分别为 11024 欧元和 6018 欧元，而英夫利昔单抗分别为 8347 欧元和 4174 欧元。在整个 12 个月的试验期间，英夫利昔单抗的缓解/低疾病活动状态患者的每月成本估计仅略低于阿巴西普（6959 欧元和 3625 欧元）。在实际治疗条件下，如果延长治疗，缓解/低疾病活动状态的每月成本将大幅有利于阿巴西普（5321 欧元和 2819 欧元），而英夫利昔单抗（7189 欧元和 3916 欧元）。如果在实际情况下治疗超过 6 个月，则阿巴西普实现缓解/低疾病活动状态的初始成本更高，但在总共 14.6 和 16.1 个月的治疗后，将得到弥补。