Real-world data analysis of the clinical and economic burden and risk factors in patients with major depressive disorder with an inadequate response to initial antidepressants

We aimed to determine the incidence of and identify the factors associated with treatment-resistant depression (TRD), psychiatric conditions, hospitalization, and cost in patients with major depressive disorder (MDD) who were treated using second-line strategies after an inadequate response to initial antidepressants (AD). Using South Korean National Health Insurance claims data (1 January 2013 to 30 June 2018), we conducted a retrospective cohort analysis in newly treated patients with MDD who subsequently switched or added AD, or added atypical antipsychotics (AAPs) as a second-line treatment. We assessed the incidence of treatment-resistant depression (TRD), psychiatric conditions, and hospitalization for the first 2 years and costs in the third year. Odds ratios (ORs) or relative ratios were estimated using logistic and linear regression models to identify the risk factors for clinical and economic outcomes. In 15,887 patients, the TRD was 16.81% during the 24-month follow-up period (14.14% in switching AD, 19.65% in adding AD, and 19.91% in adding AAP; p In patients with MDD with inadequate responses to initial AD, TRD still occurred after subsequent treatments according to clinical guidelines. Since the effectiveness of second treatment strategies can differ in reality, further analysis of the clinical and economic evidence regarding second treatment strategies, such as adding AD or AAP, is needed using real-world data.

本研究旨在明确初始抗抑郁药 (antidepressants, AD) 治疗应答不佳的重度抑郁症 (major depressive disorder, MDD) 患者中，难治性抑郁症 (treatment-resistant depression, TRD) 的发生率，并识别与该人群的难治性抑郁症、精神疾病、住院情况及医疗成本相关的影响因素，此类患者后续将采用二线治疗策略。本研究利用2013年1月1日至2018年6月30日的韩国国民健康保险索赔数据，针对初始接受抗抑郁药治疗、后续更换或加用抗抑郁药，或加用非典型抗精神病药 (atypical antipsychotics, AAPs) 作为二线治疗的新发MDD患者，开展回顾性队列分析。本研究评估了前2年的难治性抑郁症、精神疾病及住院情况发生率，以及第3年的医疗成本。通过logistic回归与线性回归模型估算比值比 (odds ratios, ORs) 或相对比，以明确临床与经济结局的危险因素。在15887例患者中，24个月随访期内难治性抑郁症的发生率为16.81%（更换AD组为14.14%、加用AD组为19.65%、加用AAP组为19.91%；P<0.05）；在初始抗抑郁药治疗应答不佳的MDD患者中，即便按照临床指南接受后续二线治疗，仍会发生难治性抑郁症。由于实际临床中二线治疗策略的疗效存在差异，需利用真实世界数据进一步分析更换抗抑郁药、加用抗抑郁药或非典型抗精神病药等二线治疗策略的临床与经济学证据。