摘 要

目的

這項分析的目的是提供一套生物製劑的藥物利用指標(依從性，轉換率和用藥量)以及相應成本(藥物，住院和專科護理)的估計，這些研究數據來自意大利國家健康服務署治療成人類風濕關節炎(RA)患者。

方法

我們利用三個地方醫療單位的行政數據庫進行了一項觀察性回顧隊列分析。我們納入了所有年齡≥18歲、診斷為RA、並在2010年1月至2012年12月(入組期)至少進行過一次生物製劑處方的患者。用藥依從性的定義是指在隨訪的最後3個月內持續使用與在研究標注日期開始時使用相同的生物製劑。藥物轉換的定義是指在隨訪的最後3個月內，使用一種與研究標注日期開始時使用的不同生物製劑。同時，我們還評估患者入院(診斷為RA或其他RA相關疾病)、專科門診服務、儀器診斷和用藥量。

結果

藥物使用分析隻考慮生物製劑，研究對象為至少90例在基線治療使用生物製劑(阿達木單抗n = 144，依那西普n = 236和英夫利昔單抗n = 94)的患者。每年的數據顯示，依那西普比阿達木單抗或英夫利昔單抗在初始治療中有更好的依從性。依那西普的特征在於隨訪期需要增加初始用藥量的患者數目最低(2.6%)以及初始用藥量減少的患者數目最高(10.5%)。依從初始治療方案的患者平均治療費用為12,388歐元(阿達木單抗為14,182歐元，依那西普為12,103歐元，英夫利昔單抗為11,002歐元)。在隨訪的第一年，轉換初始治療方案的患者治療費用高於未轉換患者的治療費用(12,710歐元對11,332歐元)。

結論

依從性，轉換率和用藥量似乎直接影響治療成本。在不依從初始治療方案的患者中，其他保健費用比依從患者高約三倍。這種差異可能對依從患者的生活質量產生積極影響。依那西普顯示出最高的治療依從性。

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.