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Real-world demographic and clinical profiles of patients with treatment-resistant depression initiated on esketamine nasal spray.
Samalin, Ludovic; Mekaoui, Lila; De Maricourt, Pierre; Sauvaget, Anne; Codet, Marie-Alix; Gaudré-Wattinne, Émeline; Wicart, Clotilde; Rothärmel, Maud.
Afiliación
  • Samalin L; CHU Clermont-Ferrand, Department of Psychiatry, University of Clermont Auvergne, CNRS, Clermont Auvergne INP, Institut Pascal (UMR 6602), Clermont-Ferrand, France.
  • Mekaoui L; GHU Paris - Psychiatry and Neurosciences, Clinique des maladies mentales et de l'encéphale, Sainte-Anne Hospital, Paris, France.
  • De Maricourt P; Department of Psychiatry, CH Ste Anne, Paris, France.
  • Sauvaget A; Movement, Interactions, Performance, MIP, Nantes Université, CHU Nantes, Nantes, France UR.
  • Codet MA; Medical Affairs, Janssen Cilag, Issy-les-Moulineaux, France.
  • Gaudré-Wattinne É; Medical Affairs, Janssen Cilag, Issy-les-Moulineaux, France.
  • Wicart C; Medical Affairs, Janssen Cilag, Issy-les-Moulineaux, France.
  • Rothärmel M; University Department of Psychiatry, Therapeutic Centre of Excellence, Institute of Psychiatry - Rouvray Hospital Centre, Sotteville-lès-Rouen, France.
Int J Psychiatry Clin Pract ; : 1-11, 2024 Sep 02.
Article en En | MEDLINE | ID: mdl-39223855
ABSTRACT

OBJECTIVE:

ESKALE is a French, multicentre, observational study of adults with treatment-resistant depression (TRD) treated with esketamine. This interim analysis describes baseline demographic and clinical characteristic evolution in patients included and treated from early access program to post-marketing launch.

METHODS:

Data were collected from medical records and included patient characteristics, disease history at esketamine initiation, use of neurostimulation, the patient's care pathway, and the number of antidepressant treatment lines prescribed prior to esketamine initiation. Descriptive statistics were used for each cohort the early access program 'Temporary Authorisation for Use' (ATU), post-ATU, and post-launch cohorts.

RESULTS:

The overall ESKALE cohort (N = 160 included; n = 157 treated with esketamine; average age 49.0 years; 66.2% female) demonstrated moderate-to-severe depression according to clinical assessment and a mean Montgomery-Åsberg Depression Rating Scale score of 32.6 (8.0); however, severity, subtype, and comorbidities were heterogeneous across the cohorts. Earlier use of esketamine and prior to alternative treatments occurred during the later cohorts.

CONCLUSION:

These findings demonstrated a high burden of TRD in these patients and that esketamine is used in TRD treatment regardless of their disease severity, subtype, or existing comorbidities. These results also suggest that esketamine is potentially a clinically useful alternative treatment, particularly with healthcare professionals gaining greater familiarity with and easier access to esketamine.
ESKALE is a long-term, French, multicentre, observational study based on secondary data in adult patients with treatment-resistant depression (TRD) who initiated esketamine treatment in one of three mutually exclusive cohorts the Temporary Authorisation for Use (ATU), post-ATU, and post-launch cohorts.ESKALE is one of the largest European real-world studies investigating the profiles of more than 150 patients and their treatment with esketamine before and after marketing authorisation.A majority of patients had moderate to severe TRD, with multiple treatment failures with medications and/or neurostimulation prior to esketamine initiation.Esketamine nasal spray administration was undertaken more frequently in an outpatient setting, with the post-administration period monitoring being undertaken mostly by nurses.Esketamine was used in patients with TRD in real-world conditions regardless of their disease severity and subtype or existing comorbidities.These results highlight both the need for an effective treatment for TRD and the adoption of esketamine by multidisciplinary teams that are involved in esketamine prescription and administration.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Int J Psychiatry Clin Pract Año: 2024 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Int J Psychiatry Clin Pract Año: 2024 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido