2 results
ESKALE study, a French real-world study describing TRD patients with Esketamine nasal spray: final analysis
- L. Samalin, L. Mekaoui, M. Rotharmel, P. de Maricourt, M.-A. Codet, E. Gaudre Wattinne
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- Journal:
- European Psychiatry / Volume 66 / Issue S1 / March 2023
- Published online by Cambridge University Press:
- 19 July 2023, p. S90
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Introduction
Treatment resistant depression (TRD) affects a substantial proportion of patients with depression and carries a large unmet need. Esketamine nasal spray (NS), in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI), has been shown to reduce depressive symptoms and risk of relapse, in patients with TRD (Popova, V., et al. 2019. Am J Psychiatry; Daly, E.J., et al. 2019. JAMA Psychiatry). Esketamine NS has been authorised by European Medicines Agency as treatment for resistant depression since December 2019. ESKALE, is the first French observational study to describe TRD patients treated with Esketamine NS under real-world settings and to provide data on this innovative solution for patients.
ObjectivesTo describe patients with TRD at Esketamine NS initiation and during the following 12-month period in real-world clinical practice.
MethodsESKALE is a French, observational, multicentre, retrospective study of adult patients with moderate to severe TRD defined as a non-response to ≥ 2 oral antidepressant. Each patient was included in one of the 3 cohorts according to Esketamine NS start date: Temporary Authorisation for Use (ATUc) cohort, post-ATU cohort or post-launch period cohort. Data were collected from medical records of patients treated with Esketamine NS between 10-29-2019 and 06-14-2022. Primary objective is to describe patients’ profile and Esketamine NS conditions of use at esketamine initiation and during the 12-month period after esketamine initiation in real-world clinical practice (either patient had stop or not the treatment). Secondary objectives are to describe Esketamine NS management, safety profile and patient pathway.
ResultsTwo standard descriptive statistical interim analysis were conducted and published in several conferences (Samalin L, et al. Presented at EPA Hybrid congress June 2022. P.2482; Samalin L, et al. Presented at ECNP Vienna, October 2022. P.0122). This final analysis describes the data collected from medical records of patients included in the study from 04-08-2020 to 06-30-2021. 157 patients were included from 26 French centers, the majority (>65%) of patients were females. Average age was 49 years old with 27 patients > 65 years old. Duration of the current depressive episode was up to 2,5 years (mean) with an average of more than three episode in the patient’s entire life (mean). At esketamine initiation, 3 patients out of 4 were clinically perceived to have severe depression with a MADRS score of 32.0 (median). Patients had mainly depression with anxious distress specifier. Esketamine NS dose at initiation was mainly 56mg.
ConclusionsEskale is the first French cohort study generating real-world evidence on treatment resistant depression patients treated with Esketamine nasal spray. Results of the final analysis confirmed the 2 interim analysis results already published.
Disclosure of InterestNone Declared
ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression
- S. Ludovic, M.A. Codet, M. Rotharmel, P. De Maricourt, J. Boursicot, E. Gaudre Wattinne
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- Journal:
- European Psychiatry / Volume 65 / Issue S1 / June 2022
- Published online by Cambridge University Press:
- 01 September 2022, pp. S270-S271
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Introduction
Esketamine nasal spray has been developed to treat adults with treatment resistant depression. On Dec.2019, EMA granted a market access approval in this indication.
ObjectivesESKALE is a descriptive study of treatment resistant depression patients treated with esketamine in France.
MethodsObservational retrospective study. 157 patients are included in 3 cohorts depending on their treatment initiation date. This abstract presents the second interim results of patients treated with esketamine and whom data collection ranges from Oct.2019 and Sept.2021.
Results66.7% of patients were females. Average age was 49 years old with 26 patients > 65 years old. Duration of the current depressive episode was 26.0 months (mean). 48.8% of patient have > 1 suicide attempt during whole life. At esketamine initiation, 78.2% patients were clinically perceived to have severe depression with a MADRS score of 32.4 (median) and a PHQ9 score of 19.5 (median). For the overall sample, esketamine was prescribed in median as a 3rd line and for 40.5% of patients after neurostimulation. The majority of the patient started esketamine at 28 mg or 56 mg and increased the dose to 84 mg. After 4 months of treatment, clinical benefits are the following: decrease of MADRS total score -16.5 points (median) corresponding to 58% of responders and a PHQ9 total score decrease of -8.6 points (median). No new safety signal detected.
ConclusionsThis second interim analysis describes patients’ profiles and clinical evolution over a longer period and a broader population than the first interim analysis. The conditions of use are consistent with the ones approved by health authorities.
DisclosureI (Marie-Alix Codet) works as a full employee at Janssen Cilag