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

Detalhes bibliográficos
Autor(a) principal: Oliveira-Maia, Albino J.
Data de Publicação: 2024
Outros Autores: Rive, Benoît, Godinov, Yordan, Mulhern-Haughey, Siobhán
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10362/174433
Resumo: Funding 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.
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spelling Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remissionresults from the ICEBERG studyesketamine nasal sprayfunctional remissionfunctioningindirect treatment comparisonpatient-reported outcomeSheehan Disability Scaletreatment resistant depressionPsychiatry and Mental healthSDG 3 - Good Health and Well-beingFunding 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.Introduction: 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.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNOliveira-Maia, Albino J.Rive, BenoîtGodinov, YordanMulhern-Haughey, Siobhán2024-10-31T23:25:52Z20242024-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/174433eng1664-0640PURE: 102216144https://doi.org/10.3389/fpsyt.2024.1459633info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-11-11T01:40:56Zoai:run.unl.pt:10362/174433Portal AgregadorONGhttps://www.rcaap.pt/oai/openairemluisa.alvim@gmail.comopendoar:71602024-11-11T01:40:56Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission
results from the ICEBERG study
title Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission
spellingShingle Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission
Oliveira-Maia, Albino J.
esketamine nasal spray
functional remission
functioning
indirect treatment comparison
patient-reported outcome
Sheehan Disability Scale
treatment resistant depression
Psychiatry and Mental health
SDG 3 - Good Health and Well-being
title_short Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission
title_full Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission
title_fullStr Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission
title_full_unstemmed Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission
title_sort Estimating the benefit of esketamine nasal spray versus real-world treatment on patient-reported functional remission
author Oliveira-Maia, Albino J.
author_facet Oliveira-Maia, Albino J.
Rive, Benoît
Godinov, Yordan
Mulhern-Haughey, Siobhán
author_role author
author2 Rive, Benoît
Godinov, Yordan
Mulhern-Haughey, Siobhán
author2_role author
author
author
dc.contributor.none.fl_str_mv NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
RUN
dc.contributor.author.fl_str_mv Oliveira-Maia, Albino J.
Rive, Benoît
Godinov, Yordan
Mulhern-Haughey, Siobhán
dc.subject.por.fl_str_mv esketamine nasal spray
functional remission
functioning
indirect treatment comparison
patient-reported outcome
Sheehan Disability Scale
treatment resistant depression
Psychiatry and Mental health
SDG 3 - Good Health and Well-being
topic esketamine nasal spray
functional remission
functioning
indirect treatment comparison
patient-reported outcome
Sheehan Disability Scale
treatment resistant depression
Psychiatry and Mental health
SDG 3 - Good Health and Well-being
description Funding 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.
publishDate 2024
dc.date.none.fl_str_mv 2024-10-31T23:25:52Z
2024
2024-01-01T00:00:00Z
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