{"title":"在常规治疗中对难治性抑郁症患者使用艾司西他敏鼻腔喷雾剂：法国真实世界研究","authors":"Ludovic Samalin, Lila Mekaoui, Maud Rothärmel, Anne Sauvaget, Clotilde Wicart, Julien Dupin, Vanessa Cohignac, Emeline Gaudre-Wattinne","doi":"10.1155/2024/7262794","DOIUrl":null,"url":null,"abstract":"<div>\n <p><i>Background</i>. The efficacy and safety of esketamine nasal spray (ESK) were established in registration trials in patients with treatment-resistant depression (TRD). This French real-world study aimed to describe the treatment patterns, effectiveness, and safety of ESK in TRD patients over a 12-month follow-up. <i>Materials and Methods</i>. This study used secondary data from patient files of hospital-based psychiatrists and started during the first French patient early access to ESK. The response and remission rates with ESK were analyzed using the total score of the Montgomery–Åsberg Depression Rating Scale (MADRS). The time to first treatment response and work resumption were described (Kaplan–Meier method). Adverse events (AEs) were analyzed. <i>Results</i>. Prior to ESK initiation, the 157 analyzed patients (age ≤ 65 years, 82.8%; female, 66.2%) had depression for 10.5 years (median, IQR, 4.2–21.2) and received a median of 6 (3–8) previous treatment lines. At ESK initiation, the mean ± SD total MADRS score was 32.1 ± 7.7. At that time, ESK was combined with antidepressants (93.6% of patients; SNRI, 65.0%; SSRI, 57.3%) and/or other potentiation strategy (63.1%; atypical antipsychotics, 36.3%; lithium, 25.6%; antiepileptics, 21.7%). During the 12-month follow-up, 125 patients (79.6%) discontinued ESK. The median duration of ESK treatment was 19.4 weeks (IQR, 4.4–40.1). At 1 month after ESK initiation, 40.2% of still treated patients met criteria for clinical response and 19.7% for remission (median time to response, 5.7 weeks; 95% CI (4.1–8.4)). 82.6% of active patients were on sick leave at ESK initiation; the work resumption rate was 24% (13%–40%) 12 weeks later. AEs were reported in 68.6% of patients, serious AEs in 17.2%, and AEs leading to ESK discontinuation in 14.6%. <i>Conclusion</i>. These real-world effectiveness and safety data were consistent with findings from previous clinical trials, describing the real-life clinical experience of patients receiving ESK and confirming that ESK has its place in therapy for the treatment of TRD.</p>\n </div>","PeriodicalId":55179,"journal":{"name":"Depression and Anxiety","volume":"2024 1","pages":""},"PeriodicalIF":4.7000,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/2024/7262794","citationCount":"0","resultStr":"{\"title\":\"Use of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression in Routine Practice: A Real-World French Study\",\"authors\":\"Ludovic Samalin, Lila Mekaoui, Maud Rothärmel, Anne Sauvaget, Clotilde Wicart, Julien Dupin, Vanessa Cohignac, Emeline Gaudre-Wattinne\",\"doi\":\"10.1155/2024/7262794\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n <p><i>Background</i>. The efficacy and safety of esketamine nasal spray (ESK) were established in registration trials in patients with treatment-resistant depression (TRD). This French real-world study aimed to describe the treatment patterns, effectiveness, and safety of ESK in TRD patients over a 12-month follow-up. <i>Materials and Methods</i>. This study used secondary data from patient files of hospital-based psychiatrists and started during the first French patient early access to ESK. The response and remission rates with ESK were analyzed using the total score of the Montgomery–Åsberg Depression Rating Scale (MADRS). The time to first treatment response and work resumption were described (Kaplan–Meier method). Adverse events (AEs) were analyzed. <i>Results</i>. Prior to ESK initiation, the 157 analyzed patients (age ≤ 65 years, 82.8%; female, 66.2%) had depression for 10.5 years (median, IQR, 4.2–21.2) and received a median of 6 (3–8) previous treatment lines. At ESK initiation, the mean ± SD total MADRS score was 32.1 ± 7.7. At that time, ESK was combined with antidepressants (93.6% of patients; SNRI, 65.0%; SSRI, 57.3%) and/or other potentiation strategy (63.1%; atypical antipsychotics, 36.3%; lithium, 25.6%; antiepileptics, 21.7%). During the 12-month follow-up, 125 patients (79.6%) discontinued ESK. The median duration of ESK treatment was 19.4 weeks (IQR, 4.4–40.1). At 1 month after ESK initiation, 40.2% of still treated patients met criteria for clinical response and 19.7% for remission (median time to response, 5.7 weeks; 95% CI (4.1–8.4)). 82.6% of active patients were on sick leave at ESK initiation; the work resumption rate was 24% (13%–40%) 12 weeks later. AEs were reported in 68.6% of patients, serious AEs in 17.2%, and AEs leading to ESK discontinuation in 14.6%. <i>Conclusion</i>. These real-world effectiveness and safety data were consistent with findings from previous clinical trials, describing the real-life clinical experience of patients receiving ESK and confirming that ESK has its place in therapy for the treatment of TRD.</p>\\n </div>\",\"PeriodicalId\":55179,\"journal\":{\"name\":\"Depression and Anxiety\",\"volume\":\"2024 1\",\"pages\":\"\"},\"PeriodicalIF\":4.7000,\"publicationDate\":\"2024-07-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1155/2024/7262794\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Depression and Anxiety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1155/2024/7262794\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PSYCHIATRY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Depression and Anxiety","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1155/2024/7262794","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PSYCHIATRY","Score":null,"Total":0}
Use of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression in Routine Practice: A Real-World French Study
Background. The efficacy and safety of esketamine nasal spray (ESK) were established in registration trials in patients with treatment-resistant depression (TRD). This French real-world study aimed to describe the treatment patterns, effectiveness, and safety of ESK in TRD patients over a 12-month follow-up. Materials and Methods. This study used secondary data from patient files of hospital-based psychiatrists and started during the first French patient early access to ESK. The response and remission rates with ESK were analyzed using the total score of the Montgomery–Åsberg Depression Rating Scale (MADRS). The time to first treatment response and work resumption were described (Kaplan–Meier method). Adverse events (AEs) were analyzed. Results. Prior to ESK initiation, the 157 analyzed patients (age ≤ 65 years, 82.8%; female, 66.2%) had depression for 10.5 years (median, IQR, 4.2–21.2) and received a median of 6 (3–8) previous treatment lines. At ESK initiation, the mean ± SD total MADRS score was 32.1 ± 7.7. At that time, ESK was combined with antidepressants (93.6% of patients; SNRI, 65.0%; SSRI, 57.3%) and/or other potentiation strategy (63.1%; atypical antipsychotics, 36.3%; lithium, 25.6%; antiepileptics, 21.7%). During the 12-month follow-up, 125 patients (79.6%) discontinued ESK. The median duration of ESK treatment was 19.4 weeks (IQR, 4.4–40.1). At 1 month after ESK initiation, 40.2% of still treated patients met criteria for clinical response and 19.7% for remission (median time to response, 5.7 weeks; 95% CI (4.1–8.4)). 82.6% of active patients were on sick leave at ESK initiation; the work resumption rate was 24% (13%–40%) 12 weeks later. AEs were reported in 68.6% of patients, serious AEs in 17.2%, and AEs leading to ESK discontinuation in 14.6%. Conclusion. These real-world effectiveness and safety data were consistent with findings from previous clinical trials, describing the real-life clinical experience of patients receiving ESK and confirming that ESK has its place in therapy for the treatment of TRD.
期刊介绍：
Depression and Anxiety is a scientific journal that focuses on the study of mood and anxiety disorders, as well as related phenomena in humans. The journal is dedicated to publishing high-quality research and review articles that contribute to the understanding and treatment of these conditions. The journal places a particular emphasis on articles that contribute to the clinical evaluation and care of individuals affected by mood and anxiety disorders. It prioritizes the publication of treatment-related research and review papers, as well as those that present novel findings that can directly impact clinical practice. The journal's goal is to advance the field by disseminating knowledge that can lead to better diagnosis, treatment, and management of these disorders, ultimately improving the quality of life for those who suffer from them.
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