Janssen EMEA, Neuss, Germany.
Institute of Psychiatry, Psychology and Neuroscience, King's College London, Department of Psychological Medicine, London, United Kingdom; South London and Maudsley NHS Foundation Trust, Bethlem Royal Hospital, Beckenham, United Kingdom.
J Affect Disord. 2021 Mar 15;283:115-122. doi: 10.1016/j.jad.2020.11.124. Epub 2020 Nov 30.
Treatment resistant depression (TRD; failure to respond to ≥2 treatments) affects ~20% of patients with major depressive disorder (MDD). Real-world data could help describe patient characteristics and TRD disease burden, to assess the unmet needs of TRD patients in Europe.
This observational study collected data from adults with moderate to severe TRD initiating a new treatment for depression, according to local standards of care. At baseline, socio-demographic characteristics, medical history, prior and current treatments were recorded. Disease severity, health-related quality of life (HRQoL), functionality and productivity were assessed.
Overall, 411 eligible patients were enrolled across seven European countries. Mean (standard deviation [SD]) patient age was 51.0 (10.8) years; 62.3% were female. Long-term sick leave was reported by 19.0% of patients; 30.2% were unemployed. The mean (SD) duration of the current episode was 2.6 (3.9) years. At baseline, mean (SD) HRQoL scores for EuroQoL 5-dimension 5-level (UK tariff) and EQ-Visual Analog Scale were 0.41 (0.25) and 41.1 (18.7), respectively. The Work Productivity and Activity Impairment questionnaire demonstrated mean (SD) absenteeism of 57.0% (44.9%) and presenteeism of 54.7% (29.5%); mean (SD) overall work impairment was 60.5% (29.9%).
Key limitations are small cohort size, absence of a control group and generalizability to countries with different healthcare models.
TRD patients had a high disease burden, low HRQoL and reduced function and productivity, with a substantial proportion unable to work. This demonstrates an unmet treatment need in TRD patients that, if addressed, could reduce the heavy personal and societal burden.
治疗抵抗性抑郁症（TRD；对≥2 种治疗无反应）影响约 20%的重度抑郁症（MDD）患者。真实世界的数据可以帮助描述患者特征和 TRD 疾病负担，评估欧洲 TRD 患者的未满足需求。
这项观察性研究根据当地的护理标准，从开始新的抑郁症治疗的中度至重度 TRD 成年患者中收集数据。在基线时，记录了社会人口统计学特征、病史、既往和当前治疗情况。评估了疾病严重程度、健康相关生活质量（HRQoL）、功能和生产力。
总体而言，来自 7 个欧洲国家的 411 名符合条件的患者入选。患者的平均（标准差[SD]）年龄为 51.0（10.8）岁；62.3%为女性。19.0%的患者请长期病假；30.2%失业。当前发作的平均（SD）持续时间为 2.6（3.9）年。基线时，欧洲五维健康量表 5 级（英国关税）和 EQ-视觉模拟量表的平均（SD）HRQoL 评分分别为 0.41（0.25）和 41.1（18.7）。工作生产力和活动障碍问卷显示，旷工率为 57.0%（44.9%），工作效率下降率为 54.7%（29.5%）；总体工作障碍率为 60.5%（29.9%）。
主要局限性是队列规模小，缺乏对照组以及在具有不同医疗保健模式的国家中的推广性。
TRD 患者疾病负担高，HRQoL 低，功能和生产力下降，相当一部分患者无法工作。这表明 TRD 患者存在未满足的治疗需求，如果得到解决，可能会减轻沉重的个人和社会负担。
