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Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission

2024-10Artigo científico Acesso aberto
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dc.contributor.authorOliveira-Maia, Albino J.
dc.contributor.authorOliveira-Maia, AJ
dc.contributor.authorRive, Benoît
dc.contributor.authorGodinov, Yordan
dc.contributor.authorMulhern-Haughey, Siobhán
dc.contributor.institutionNOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
dc.contributor.pblFrontiers Media
dc.date.accessioned2024-10-31T23:25:52Z
dc.date.available2024-10-31T23:25:52Z
dc.date.issued2024-10
dc.descriptionFunding Information: AJO-M: received grants from Compass Pathways, Ltd., Janssen and Schuhfried GmBH; investigator driven research funded by Funda\u00E7\u00E3o para Ci\u00EAncia e Tecnologia (PTDC/SAU-NUT/3507/2021; PTDC/MED-NEU/1552/2021; PTDC/MED NEU/31331/2017), Funda\u00E7\u00E3o para Ci\u00EAncia e Tecnologia and FEDER (PTDC/MED-NEU/30845/2017_LISBOA-01-0145-FEDER-030845; PTDC/MEC-PSQ/30302/2017_LISBOA-01-0145-FEDER-30302), the European Research Council (ERC-2020-STG-Grant 950357), the European Union Horizon programmes H2020 SC1 2017 CNECT 2 777167 BOUNCE; (H2020 SC1 DTH 2019 875358 FAITH; HORIZON-HLTH-2023-DISEASE-03-101137378-PsyPal) and the European Joint Programme in Rare Diseases (Joint Translational Call 2019) through Funda\u00E7\u00E3o para Ci\u00EAncia e Tecnologia (EJPRD/0001/2020); received payment, honoraria or support for attending meetings from MSD, Neurolite AG Angelini, Janssen and the European Monitoring Centre for Drugs and Drug Addiction; Vice-President of the Portuguese Society for Psychiatry and Mental Health; Head of the Psychiatry Working Group for the National Board of Medical Examination (GPNA) at the Portuguese Medical Association and Portuguese Ministry of Health. BR, YG, and SM-H: Employees of Janssen; hold Johnson & Johnson company stocks/stock options. Funding Information: The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. The authors declare that this study received funding from Janssen EMEA. This article was based on the original studies NCT02497287 and 54135419DEP4001, both sponsored by Janssen EMEA. Support for third-party writing assistance for this article, provided by Laura Mawdsley, MSc, Costello Medical, Cambridge, UK, was funded by Janssen EMEA in accordance with Good Publication Practice (GPP 2022) guidelines. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication. Funding Information: The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. The authors declare that this study received funding from Janssen EMEA. This article was based on the original studies NCT02497287 and 54135419DEP4001, both sponsored by Janssen EMEA. Support for third-party writing assistance for this article, provided by Laura Mawdsley, MSc, Costello Medical, Cambridge, UK, was funded by Janssen EMEA in accordance with Good Publication Practice (GPP 2022) guidelines. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication. Acknowledgments Publisher Copyright: Copyright © 2024 Oliveira-Maia, Rive, Godinov and Mulhern-Haughey.
dc.description.abstractIntroduction: 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. Methods: 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. Results: 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. Conclusions: 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.en
dc.description.versionpublishersversion
dc.description.versionpublished
dc.format.extent1589083
dc.identifier.doi10.3389/fpsyt.2024.1459633
dc.identifier.issn1664-0640
dc.identifier.otherPURE: 102216144
dc.identifier.otherPURE UUID: a5e9a953-afa9-4a5a-a0cb-76a06bf45eda
dc.identifier.otherScopus: 85207011347
dc.identifier.urihttp://hdl.handle.net/10362/174433
dc.identifier.urlhttps://www.scopus.com/pages/publications/85207011347
dc.language.isoeng
dc.peerreviewedyes
dc.subjectesketamine nasal spray
dc.subjectfunctional remission
dc.subjectfunctioning
dc.subjectindirect treatment comparison
dc.subjectpatient-reported outcome
dc.subjectSheehan Disability Scale
dc.subjecttreatment resistant depression
dc.subjectPsychiatry and Mental health
dc.subjectSDG 3 - Good Health and Well-being
dc.titleEstimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remissionen
dc.title.subtitleresults from the ICEBERG studyen
dc.typejournal article
degois.publication.titleFrontiers in Psychiatry
degois.publication.volume15
dspace.entity.typePublication
person.familyNameOliveira-Maia
person.givenNameAlbino Jorge
person.identifier.ciencia-idED15-6691-FEC7
person.identifier.orcid0000-0001-5071-3007
person.identifier.ridB-7976-2009
person.identifier.scopus-author-id14060820700
rcaap.rightsopenAccess
relation.isAuthorOfPublication402bb6ca-e5db-422a-9d43-a807d4076d38
relation.isAuthorOfPublication.latestForDiscovery402bb6ca-e5db-422a-9d43-a807d4076d38

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