A descriptive study of treatment-resistant depression patients treated by esketamine during ATUc program, post-ATU period or post-launch period (ESKALE study)

Introduction Depression is the most prevalent mental disorder worldwide [1] . Almost one out of three patients does not correctly respond to current antidepressant (AD) treatments and is at risk to evolve toward treatment-resistant depression (TRD) [2] . Spravato® (esketamine) was granted marketing authorisation on 18 December 2019 for the treatment of moderate to severe depressive episode which have not responded to at least two different antidepressants in the current moderate to severe depressive episode in adults in combination with a SSRI or SNRI. Between the end of ATUc program and the Official Journal publication of the medicinal product, access modalities of Spravato® have been defined by HAS (Haute Autorite de Sante) in the scope of post-ATU program. On 24 June 2020, the Transparency Committee of the HAS adopted a favourable opinion for the reimbursement of Spravato®, published to the Official Journal on 01/10/20. ESKALE study is intended to describe TRD patients at esketamine initiation and during 12 months under real-life clinical routine practice. Method ESKALE is a retrospective data collection based on patient medical files. 150 patients are expected to be included in the study before 31/06/21. Patients are included in 3 cohorts depending on their initiation date of esketamine, either during the ATUc program, the post-ATU period or after commercial launch. This abstract deals with data of the intermediate analysis performed on the 62 first patients included in the study from 26/06/2020 to 11/01/2021 who were treated by esketamine between 29/10/2019 and 01/03/2021. Results The average age at inclusion was 49.2 years old and 67.7 % of patients were female. Regarding disease history, the median time of esketamine initiation since first diagnosis of depression is 9.3 years, the mean number of characterized depressive episode was 3.6 and within average 2.1 suicide attempts during whole life. The actual depressive episode at esketamine initiation was evaluated as moderate for 25 % of patients, severe for 75% of patients and MADRS mean score was 32.3. 40% of patients were inpatient for their first esketamine administration whereas 60% were outpatient. 69.4% of patients received 56 mg of esketamine for their first administration and among them, 97.6% of patients were less than 65 years old. 62.9% of patients had at least one adverse event (AE). The main AE reported were nervous system disorder (38.7%) among which 16.1% of patients experienced sedation and 21% somnolence. Dissociative disorder occurred in 32.3% of patients. These AE were expected AE related to esketamine in post-administration period. Conclusion This intermediate analysis describes real life clinical practice for the treatment of 62 patients presenting treatment resistant depression and treated with Esketamine nasal spray. These data allow to better understand the profile of treated patients and their short-term clinical evolution.