摘 要

        目的

        这项分析的目的是提供一套生物制剂的药物利用指标(依从性，转换率和用药量)以及相应成本(药物，住院和专科护理)的估计，这些研究数据来自意大利国家健康服务署治疗成人类风湿关节炎(RA)患者。

        方法

        我们利用三个地方医疗单位的行政数据库进行了一项观察性回顾队列分析。我们纳入了所有年龄≥18岁、诊断为RA、并在2010年1月至2012年12月(入组期)至少进行过一次生物制剂处方的患者。用药依从性的定义是指在随访的最后3个月内持续使用与在研究标注日期开始时使用相同的生物制剂。药物转换的定义是指在随访的最后3个月内，使用一种与研究标注日期开始时使用的不同生物制剂。同时，我们还评估患者入院(诊断为RA或其他RA相关疾病)、专科门诊服务、仪器诊断和用药量。

        结果

        药物使用分析只考虑生物制剂，研究对象为至少90例在基线治疗使用生物制剂(阿达木单抗n = 144，依那西普n = 236和英夫利昔单抗n = 94)的患者。每年的数据显示，依那西普比阿达木单抗或英夫利昔单抗在初始治疗中有更好的依从性。依那西普的特征在于随访期需要增加初始用药量的患者数目最低(2.6%)以及初始用药量减少的患者数目最高(10.5%)。依从初始治疗方案的患者平均治疗费用为12,388欧元(阿达木单抗为14,182欧元，依那西普为12,103欧元，英夫利昔单抗为11,002欧元)。在随访的第一年，转换初始治疗方案的患者治疗费用高于未转换患者的治疗费用(12,710欧元对11,332欧元)。

        结论

        依从性，转换率和用药量似乎直接影响治疗成本。在不依从初始治疗方案的患者中，其他保健费用比依从患者高约三倍。这种差异可能对依从患者的生活质量产生积极影响。依那西普显示出最高的治疗依从性。

        原文

Persistence, switch rates, drug consumption and costs of biological treatment of rheumatoid arthritis: an observational study in Italy.

Abstract

OBJECTIVE:

        The aim of this analysis was to provide an estimate of drug utilization indicators (persistence, switch rate and drug consumption) on biologics and the corresponding costs (drugs, admissions and specialist care) incurred by the Italian National Health Service in the management of adult patients with rheumatoid arthritis (RA).

METHODS:

        We conducted an observational retrospective cohort analysis using the administrative databases of three local health units. We considered all patients aged ≥18 years with a diagnosis of RA and at least one biologic drug prescription between January 2010 and December 2012 (recruitment period). Persistence was defined as maintenance over the last 3 months of the follow-up period of the same biological therapy administered at the index date. A switch was defined as the presence of a biological therapy other than that administered at the index date during the last 3 months of the follow-up period. Hospital admissions (with a diagnosis of RA or other RA-related diagnoses), specialist outpatient services, instrumental diagnostics and pharmaceutical consumption were assessed.

RESULTS:

        The drug utilization analysis took into account only biologics with at least 90 patients on treatment at baseline (adalimumab n=144, etanercept n=236 and infliximab n=94). In each year, etanercept showed better persistence with initial treatment than adalimumab or infliximab. Etanercept was characterized by the lowest number of patients increasing the initial drug consumption (2.6%) and by the highest number of patients reducing the initial drug consumption (10.5%). The mean cost of treatment for a patient persisting with the initial treatment was €12,388 (€14,182 for adalimumab, €12,103 for etanercept and €11,002 for infliximab). The treatment costs for patients switching from initial treatment during the first year of follow-up were higher than for patients who did not switch (€12,710 vs. €11,332).

CONCLUSION:

        Persistence, switch rate and drug consumption seem to directly influence treatment costs. In subjects not persisting with initial treatment, other health care costs were approximately three times higher than for persistent patients. This difference could suggest a positive effect on the quality of life for persistent patients. Etanercept showed the highest persistence with treatment.