ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression
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. Objectives ESKALE is a descriptive study of treatment resistant depression patients treated with esketamine in France....
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2022-06-01
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| Series: | European Psychiatry |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S0924933822006939/type/journal_article |
| _version_ | 1797617542205800448 |
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| author | S. Ludovic M.A. Codet M. Rotharmel P. De Maricourt J. Boursicot E. Gaudre Wattinne |
| author_facet | S. Ludovic M.A. Codet M. Rotharmel P. De Maricourt J. Boursicot E. Gaudre Wattinne |
| author_sort | S. Ludovic |
| collection | DOAJ |
| description |
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.
Objectives
ESKALE is a descriptive study of treatment resistant depression patients treated with esketamine in France.
Methods
Observational 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.
Results
66.7% 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.
Conclusions
This 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.
Disclosure
I (Marie-Alix Codet) works as a full employee at Janssen Cilag
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| first_indexed | 2024-03-11T07:57:29Z |
| format | Article |
| id | doaj.art-291ca810de574584b12e103fe6e11184 |
| institution | Directory Open Access Journal |
| issn | 0924-9338 1778-3585 |
| language | English |
| last_indexed | 2024-03-11T07:57:29Z |
| publishDate | 2022-06-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | European Psychiatry |
| spelling | doaj.art-291ca810de574584b12e103fe6e111842023-11-17T05:05:20ZengCambridge University PressEuropean Psychiatry0924-93381778-35852022-06-0165S270S27110.1192/j.eurpsy.2022.693ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depressionS. Ludovic0M.A. Codet1M. Rotharmel2P. De Maricourt3J. Boursicot4E. Gaudre Wattinne5CHU Clermont-Ferrand, Department Of Psychiatry, University Of Auvergne,, Clermont-Ferrand, FranceJanssen Cilag, Medical Affairs, Issy les Moulineaux, FranceCH Rouvray, Department Of Psychiatry, Sotteville-lès-Rouen, FranceCH Ste Anne, Department Of Psychiatry, Paris, FranceJanssen Cilag, Medical Affairs, Issy les Moulineaux, FranceJanssen Cilag, Medical Affairs, Issy les Moulineaux, France 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. Objectives ESKALE is a descriptive study of treatment resistant depression patients treated with esketamine in France. Methods Observational 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. Results 66.7% 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. Conclusions This 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. Disclosure I (Marie-Alix Codet) works as a full employee at Janssen Cilag https://www.cambridge.org/core/product/identifier/S0924933822006939/type/journal_articleesketamineTreatment Resistant Depressionretrospective studyReal World Evidence |
| spellingShingle | S. Ludovic M.A. Codet M. Rotharmel P. De Maricourt J. Boursicot E. Gaudre Wattinne ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression European Psychiatry esketamine Treatment Resistant Depression retrospective study Real World Evidence |
| title | ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression |
| title_full | ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression |
| title_fullStr | ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression |
| title_full_unstemmed | ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression |
| title_short | ESKALE study, a French real-world study of esketamine nasal spray for patients with treatment-resistant depression |
| title_sort | eskale study a french real world study of esketamine nasal spray for patients with treatment resistant depression |
| topic | esketamine Treatment Resistant Depression retrospective study Real World Evidence |
| url | https://www.cambridge.org/core/product/identifier/S0924933822006939/type/journal_article |
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