Skip to main content

ORIGINAL RESEARCH article

Front. Psychiatry
Sec. Mood Disorders
Volume 15 - 2024 | doi: 10.3389/fpsyt.2024.1459633

Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission: Results from the ICEBERG study

Provisionally accepted
Albino J. Oliveira-Maia Albino J. Oliveira-Maia 1,2Benoit Rive Benoit Rive 3*Costello Medical Costello Medical 4,5Yordan Godinov Yordan Godinov 6Siobhán Mulhern-Haughey Siobhán Mulhern-Haughey 7
  • 1 Champalimaud Research and Clinical Centre, Champalimaud Foundation, Lisbon, Portugal
  • 2 NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade Nova de Lisboa, Lisbon, Portugal
  • 3 Janssen EMEA, Paris, France
  • 4 Costello Medical, Cambridge, United Kingdom
  • 5 Please delete this author, Submission Only, United Kingdom
  • 6 Janssen EMEA, Sofia, Bulgaria
  • 7 Janssen EMEA, Dublin, Ireland

The final, formatted version of the article will be published soon.

    Treatment resistant depression (TRD) affects approximately 10-30% of patients with major depressive disorder, and most patients with TRD do not respond to real-world treatments (RWT). Treatment with esketamine nasal spray (NS) plus a selective serotonin or serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) has significant long-term clinical benefit over RWT in patients with TRD. However, the impact on patient-reported function remains to be determined.The ICEBERG analysis was an indirect treatment comparison performed using data from two studies of patients with TRD: SUSTAIN-2 (esketamine NS; NCT02497287) and the European Observational TRD Cohort (EOTC; RWT; NCT03373253; clinicaltrials.gov). Here, patient-reported functional remission, assessed using the Sheehan Disability Scale (SDS), was defined as SDS ≤6 at Month 6. Analyses were conducted using propensity score re-weighting and multivariable models based on 18 covariates.At Month 6, the probability of functional remission in esketamine NS-treated patients from SUSTAIN-2 (n=512) was 25.6% (95% confidence interval [CI] 21.8-29.4), while the adjusted probability for RWT patients from the EOTC (n=184) was 11.5% (95% CI 6.9-16.1; relative risk: 2.226 [95% CI 1.451-3.416]; p=0.0003). In the total combined population (n=696), patients who did not achieve clinical response or remission had a low probability of achieving functional remission (5.84% and 8.76%, respectively). However, for patients who did achieve clinical response or remission, the probability of achieving functional remission was greater (43.38% and 54.15%, respectively), although many still did not achieve this status.For patients with TRD, esketamine NS had a significant functional benefit versus RWT after 6 months of treatment. Irrespective of treatment, achievement of clinical response or remission was insufficient to attain functional remission. Nevertheless, clinical remission increased the likelihood of achieving functional remission, further supporting an important role for clinical remission in for the path towards functional recovery.

    Keywords: treatment resistant depression, Patient-reported outcome, indirect treatment comparison, functional remission, Esketamine nasal spray, functioning, Sheehan Disability Scale

    Received: 04 Jul 2024; Accepted: 30 Aug 2024.

    Copyright: © 2024 Oliveira-Maia, Rive, Medical, Godinov and Mulhern-Haughey. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Benoit Rive, Janssen EMEA, Paris, France

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.