Eli Lilly & Co., Shanghai, China.
National Taiwan University, Taipei, Taiwan.
PLoS One. 2018 Apr 6;13(4):e0193489. doi: 10.1371/journal.pone.0193489. eCollection 2018.
Previous studies in Taiwan utilizing the Taiwan's National Health Insurance Database (NHIRD) have estimated the direct healthcare costs of RA patients, but they have not focused on patients on bDMARDs, or considered patients' response to therapy.
The objective of this study was to estimate the rate of inadequate response for patients newly treated with biologic disease-modifying antirheumatic drugs (bDMARDs) as well as their costs and resource use.
Data were from the catastrophic illness file within the NHIRD from 1/1/2009 to 12/31/2013. Patients with RA, which was categorized by the presence of a catastrophic illness card, that were previously bDMARD-naïve, were included in this study if they initiated their first bDMARD during the index period. The index period included all of 2010, a pre-index period consisting of the index date- 365 days, and a follow-up period including the index date to 365 days post-index, were also included. Previously biologically-naïve patients were indexed into the study on the date of their first claim for a bDMARD. A validated algorithm was used to examine the rate of inadequate response (IR) in the biologically-naïve cohort of patients. Inadequate responders met one or more of the following criteria during their year of follow-up: low adherence (proportion of days covered <0.80); switched to or added a second bDMARD; added a new conventional synthetic DMARD (csDMARD); received ≥1 glucocorticoid injection; or increased oral glucocorticoid dosing. All-cause mean annual direct costs and resource use were measured in the year of follow-up. Costs were converted from NT$ to USD using 1 NT$ = 0.033 USD.
A total of 818 patients with RA initiated their first bDMARD (54% etanercept and 46% adalimumab) in 2010. After one year of follow-up, 32% (n = 258) were classified as stable, 66% (n = 540) had an IR, and 2% (n = 20) were lost to follow-up. During the follow-up period mean annual total direct costs were $16,136 for stable patients compared to $14,154 for patients with IR. Mean annual non-medication direct costs were $937 for stable patients and $1,574 for patients with IR. Mean annual hospitalizations were higher for patients with IR (0.46) compared to stable patients (0.10) during the one year follow-up period.
The majority of patients that were previously naïve to bDMARDs had an IR to their first bDMARD during the year of follow-up. Patients with an IR had numerically increased all-cause resource utilization and non-medication costs during the follow-up period compared to patients with stable disease. This level of IR suggests an unmet need in the RA treatment paradigm.
台湾先前利用全民健康保险数据库（NHIRD）进行的研究估计了 RA 患者的直接医疗保健成本，但这些研究并未关注接受生物疾病修正抗风湿药物（bDMARDs）治疗的患者，或考虑患者对治疗的反应。
本研究旨在估计新接受生物疾病修正抗风湿药物（bDMARDs）治疗的患者治疗反应不足的发生率，以及他们的成本和资源利用情况。
数据来自 NHIRD 的灾难性疾病档案，时间范围为 2009 年 1 月 1 日至 2013 年 12 月 31 日。RA 患者在索引日期前曾使用过 bDMARD 治疗，但未使用过 bDMARD，并且患有 RA，该疾病通过存在灾难性疾病卡来分类，这些患者被纳入本研究。索引期包括 2010 年的全部时间，预索引期包括索引日期前 365 天，随访期包括索引日期后的 365 天。以前对生物制剂无反应的患者在其首次使用 bDMARD 的日期被索引到研究中。使用验证算法检查生物制剂无反应患者队列中的反应不足发生率。在随访期间，治疗反应不足的患者符合以下一项或多项标准：低依从性（覆盖天数比例<0.80）；转换或添加第二种 bDMARD；添加新的常规合成 DMARD（csDMARD）；接受≥1 次糖皮质激素注射；或增加口服糖皮质激素剂量。在随访年内测量了所有原因的平均年度直接成本和资源利用情况。使用 1 新台币=0.033 美元将所有成本从新台币转换为美元。
共有 818 名 RA 患者于 2010 年首次使用 bDMARD（54%依那西普和 46%阿达木单抗）。随访一年后，32%（n=258）被归类为稳定，66%（n=540）出现治疗反应不足，2%（n=20）失访。在随访期间，稳定患者的平均年度总直接费用为 16136 美元，而治疗反应不足的患者为 14154 美元。稳定患者的平均年度非药物直接费用为 937 美元，而治疗反应不足的患者为 1574 美元。在随访的一年期间，治疗反应不足的患者的平均年度住院次数（0.46）高于稳定患者（0.10）。
在随访年内，大多数以前对 bDMARD 无反应的患者对其首次 bDMARD 有反应不足。与疾病稳定的患者相比，治疗反应不足的患者在随访期间的全因资源利用率和非药物成本均有增加。这种治疗反应不足的发生率表明 RA 治疗模式存在未满足的需求。
