■ESKALE是法国人,多中心,观察性研究成人治疗难治性抑郁症(TRD)与艾氯胺酮治疗。该中期分析描述了从早期访问计划到上市后启动的患者纳入和治疗的基线人口统计学和临床特征演变。
■数据是从医疗记录中收集的,包括患者特征,esketamine开始时的病史,使用神经刺激,患者的护理途径,以及在开始使用艾氯胺酮之前规定的抗抑郁治疗线的数量。对每个队列使用描述性统计:早期访问计划\“临时授权使用\”(ATU),后ATU,和发射后的队列。
■整个ESKALE队列(包括N=160;n=157例接受艾氯胺酮治疗;平均年龄49.0岁;66.2%的女性)根据临床评估显示中度至重度抑郁症,平均蒙哥马利-奥斯贝格抑郁量表评分为32.6(8.0);然而,严重程度,子类型,合并症在队列中是异质的。早期使用艾氯胺酮和在替代治疗之前发生在后来的队列中。
■这些研究结果表明,这些患者的TRD负担很高,并且无论疾病严重程度如何,都使用艾氯胺酮治疗TRD。子类型,或现有的合并症。这些结果还表明,艾氯胺酮可能是临床上有用的替代治疗方法,特别是与医疗保健专业人员获得更多的熟悉和更容易获得的esketamine。
ESKALE是一个长期的,法语,多中心,观察性研究基于成人难治性抑郁症(TRD)患者的次要数据,这些患者在三个相互排斥的队列中启动了艾氯胺酮治疗:临时授权使用(ATU),后ATU,和发射后的队列。ESKALE是欧洲最大的现实世界研究之一,调查了150多名患者的概况以及在上市许可之前和之后使用esketamine的治疗。大多数患者患有中度至重度TRD,在开始使用艾氯胺酮之前,多次药物和/或神经刺激治疗失败。在门诊环境中,埃斯克他明鼻腔喷雾剂的给药频率更高,管理后的监测主要由护士进行。Esketamine用于现实世界中的TRD患者,无论其疾病的严重程度和亚型或存在的合并症如何。这些结果强调了对TRD的有效治疗以及参与esketamine处方和给药的多学科团队采用esketamine的需求。
UNASSIGNED: ESKALE is a French, multicentre, observational study of adults with treatment-resistant depression (TRD) treated with esketamine. This interim analysis describes baseline demographic and clinical characteristic evolution in patients included and treated from early access program to post-marketing launch.
UNASSIGNED: Data were collected from medical records and included patient characteristics, disease history at esketamine initiation, use of neurostimulation, the patient\'s care pathway, and the number of antidepressant treatment lines prescribed prior to esketamine initiation. Descriptive statistics were used for each cohort: the early access program \'Temporary Authorisation for Use\' (ATU), post-ATU, and post-launch cohorts.
UNASSIGNED: The overall ESKALE cohort (N = 160 included; n = 157 treated with esketamine; average age 49.0 years; 66.2% female) demonstrated moderate-to-severe depression according to clinical assessment and a mean Montgomery-Åsberg Depression Rating Scale score of 32.6 (8.0); however, severity, subtype, and comorbidities were heterogeneous across the cohorts. Earlier use of esketamine and prior to alternative treatments occurred during the later cohorts.
UNASSIGNED: These findings demonstrated a high burden of TRD in these patients and that esketamine is used in TRD treatment regardless of their disease severity, subtype, or existing comorbidities. These results also suggest that esketamine is potentially a clinically useful alternative treatment, particularly with healthcare professionals gaining greater familiarity with and easier access to esketamine.
ESKALE is a long-term, French, multicentre, observational study based on secondary data in adult patients with treatment-resistant depression (TRD) who initiated esketamine treatment in one of three mutually exclusive cohorts: the Temporary Authorisation for Use (ATU), post-ATU, and post-launch cohorts.ESKALE is one of the largest European real-world studies investigating the profiles of more than 150 patients and their treatment with esketamine before and after marketing authorisation.A majority of patients had moderate to severe TRD, with multiple treatment failures with medications and/or neurostimulation prior to esketamine initiation.Esketamine nasal spray administration was undertaken more frequently in an outpatient setting, with the post-administration period monitoring being undertaken mostly by nurses.Esketamine was used in patients with TRD in real-world conditions regardless of their disease severity and subtype or existing comorbidities.These results highlight both the need for an effective treatment for TRD and the adoption of esketamine by multidisciplinary teams that are involved in esketamine prescription and administration.