Effectiveness and Safety of Vortioxetine for Major Depressive Disorder in Real-World Clinical Practice: Results from the Single-Arm RELIEVE China Study

Gang Wang,1,&ast; Le Xiao,1,&ast; Hongye Ren,2 Kenneth Simonsen,2 Jingdong Ma,3 Xiangdong Xu,4 Ping Guo,5 Zhiren Wang,6 Ludong Bai,7 Elin Heldbo Reines,2 Lene Hammer-Helmich2 1The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital & the Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, People’s Republic of China; 2Medical Affairs, H. Lundbeck A/S, Valby, Denmark; 3Medical Affairs, Lundbeck China, Beijing, People’s Republic of China; 4Department of Psychiatry, Xinjiang Mental Health Center, Xinjiang, People’s Republic of China; 5Department of Psychosomatic Disorders, The 3rd People’s Hospital of Huzhou City, Huzhou, People’s Republic of China; 6Department of Science & Technology, Beijing Huilongguan Hospital, Beijing, People’s Republic of China; 7Department of Psychiatry, Shandong Mental Health Center, Shandong, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Elin Heldbo Reines, Medical Affairs, H. Lundbeck A/S, Ottiliavej 9, Valby, 2500, Denmark, Tel +45 30832313, Email er@lundbeck.comBackground: Major depressive disorder (MDD) affects > 163 million people worldwide and is a leading cause of disability in China. Functional impairment occurs alongside cognitive symptoms, anxiety, and depression, reducing quality of life and productivity in patients with MDD.Purpose: The multimodal antidepressant vortioxetine has demonstrated efficacy in relieving depressive and functional symptoms of MDD in randomized controlled trials (RCTs). The RELIEVE China study aimed to investigate the real-world effectiveness of vortioxetine in China.Patients and Methods: This was an observational, prospective cohort study in patients with MDD initiating treatment with vortioxetine at physician’s discretion in China. Participants were followed up for 24 weeks and assessed at 3 time points: baseline, week 8, and week 24. The primary objective was to assess the change from baseline to weeks 8 and 24 in functional impairment as measured by Sheehan Disability Scale (SDS) total score. Additional assessments included SDS subdomains, measures of depression severity, anxiety, and cognition. The safety and tolerability of vortioxetine were also examined.Results: In total, 859 patients were included in the analysis. A consistent and significant improvement in functional impairment was observed during the study, with baseline mean SDS total score (16.7 points) decreasing by 5.42 (SE, 0.22) and 8.71 (SE, 0.226) points at week 8 and week 24, respectively (P< 0.0001). Improvements in other functioning, cognitive, and anxiety assessments were also observed (all P< 0.0001). A total of 74.7% of patients had responded, and 63.9% had reached remission at week 24. The tolerability profile of vortioxetine in this real-world population was consistent with the established tolerability profile for this drug.Conclusion: This study demonstrated the short- and long-term effectiveness and tolerability of vortioxetine for patients with MDD in a real-world setting in China. These findings are consistent with the efficacy and safety profile observed during RCTs.Keywords: China, cognition, functioning, major depressive disorder, real-world evidence, vortioxetine