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美国接受 Esketamine 鼻喷雾剂或常规疗法治疗的难治性抑郁症患者的真实世界特征。

Characteristics of Real-world Commercially Insured Patients With Treatment-resistant Depression Initiated on Esketamine Nasal Spray or Conventional Therapies in the United States.

机构信息

Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.

Analysis Group, Inc., Montréal, Québec, Canada.

出版信息

Clin Ther. 2022 Nov;44(11):1432-1448. doi: 10.1016/j.clinthera.2022.09.005. Epub 2022 Oct 4.

DOI:10.1016/j.clinthera.2022.09.005
PMID:36207167
Abstract

PURPOSE

This study aimed to characterize patients with treatment-resistant depression (TRD) initiating esketamine or conventional therapies.

METHODS

Adults with major depressive disorder (MDD) were selected from the IBM MarketScan Databases. A claims-based algorithm identified patients with evidence of TRD, defined as initiation of a new antidepressant therapy after 2 different antidepressant trials of adequate dose and duration during the most recent major depressive episode. Patients receiving treatment on/after March 5, 2019 (esketamine approval date for TRD), were classified to the esketamine cohort if they newly initiated esketamine (index date) or to the TRD conventional therapies cohorts if they newly initiated electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or pharmacologic therapies (index date was the therapy initiation date, prioritizing ECT, then TMS, then pharmacologic antidepressant therapies). Patient characteristics in the 6 months before therapy initiation were described.

FINDINGS

The esketamine cohort included 246 patients (mean age, 46.5 years; 63.0% female), and the TRD conventional therapies cohorts included 104,164 patients (mean age, 46.9 years; 74.8% female; 0.4% initiated ECT, 1.2% initiated TMS). During the 6 months preindex, in the esketamine and TRD conventional therapies cohorts, 77.6% and 41.4% received psychotherapy and 82.9% and 34.2% had a psychiatrist visit, respectively. Most patients had outpatient care for MDD in the esketamine (91.9%) and TRD conventional therapies (63.6%) cohorts; 57.3% and 21.0% received care at specialized mental health care settings. MDD was classified as "severe" among 81.3% and 35.1% of patients in the esketamine and TRD conventional therapies cohorts . Preindex mental health-related (MHR) inpatient admissions and emergency department visits were identified in 12.2% and 16.3% of the esketamine cohort and in 8.2% and 10.3% of the TRD conventional therapies cohort. Before therapy initiation, 34.6% and 17.6% of the esketamine and TRD conventional therapies cohorts received ≥3 unique antidepressants. Suicidal ideation or behavior was observed in 8.5% and 3.6% of the esketamine and TRD conventional therapies cohorts pretherapy initiation. Mean monthly all-cause health care costs in the esketamine cohort were $2532 (58.2% MHR); in the TRD conventional therapies cohorts, costs were $1873 (32.4% MHR).

IMPLICATIONS

Among patients with TRD, those initiating esketamine relative to conventional therapies displayed higher MDD severity, used more MHR inpatient/emergency department services and antidepressant treatments, and incurred higher health care costs 6 months pretherapy initiation. These findings suggest potential benefits of identifying and treating patients with TRD earlier with more effective treatments and should inform payers in consideration of esketamine coverage.

摘要

目的

本研究旨在描述开始使用氯胺酮或常规疗法治疗的难治性抑郁症(TRD)患者的特征。

方法

从 IBM MarketScan 数据库中选择患有重度抑郁症(MDD)的成年人。基于索赔的算法确定了 TRD 患者的证据,定义为在最近一次重度抑郁发作期间,经过 2 次不同剂量和持续时间的抗抑郁药试验后,开始新的抗抑郁治疗。如果在 2019 年 3 月 5 日(氯胺酮治疗 TRD 的批准日期)之后开始治疗/接受治疗,那么如果他们新开始使用氯胺酮(索引日期),则将其归入氯胺酮组;如果他们新开始电休克疗法(ECT)、经颅磁刺激(TMS)或药物治疗(索引日期为治疗开始日期,优先考虑 ECT,其次是 TMS,然后是药物抗抑郁治疗),则归入 TRD 常规治疗组。描述了治疗开始前 6 个月的患者特征。

发现

氯胺酮组包括 246 名患者(平均年龄 46.5 岁;63.0%为女性),TRD 常规治疗组包括 104,164 名患者(平均年龄 46.9 岁;74.8%为女性;0.4%开始 ECT,1.2%开始 TMS)。在索引前 6 个月内,氯胺酮和 TRD 常规治疗组中,分别有 77.6%和 41.4%接受心理治疗,分别有 82.9%和 34.2%看精神科医生。大多数患者在氯胺酮(91.9%)和 TRD 常规治疗组(63.6%)中接受门诊治疗;57.3%和 21.0%在专门的精神卫生保健机构接受治疗。在氯胺酮和 TRD 常规治疗组中,81.3%和 35.1%的患者分别被归类为“重度”抑郁症。在氯胺酮组中,12.2%和 16.3%的患者和 TRD 常规治疗组中 8.2%和 10.3%的患者在治疗前都有精神健康相关(MHR)住院和急诊就诊记录。在治疗开始前,氯胺酮和 TRD 常规治疗组中,分别有 34.6%和 17.6%的患者接受了≥3 种不同的抗抑郁药。在治疗开始前,氯胺酮和 TRD 常规治疗组中有 8.5%和 3.6%的患者出现自杀意念或行为。在氯胺酮组中,每月的全因医疗保健费用平均为 2532 美元(58.2%为 MHR);在 TRD 常规治疗组中,费用为 1873 美元(32.4%为 MHR)。

意义

在 TRD 患者中,与常规治疗相比,开始使用氯胺酮的患者的 MDD 严重程度更高,使用了更多的 MHR 住院/急诊服务和抗抑郁药物治疗,并且在治疗前 6 个月的医疗保健费用更高。这些发现表明,更早地使用更有效的治疗方法识别和治疗 TRD 患者可能会带来更大的益处,并应告知支付方考虑氯胺酮的覆盖范围。

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