Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression

Detalhes bibliográficos
Autor(a) principal: Oliveira-Maia, Albino J.
Data de Publicação: 2023
Outros Autores: Rive, Benoit, Morrens, Joachim, Godinov, Yordan, Cabrieto, Jedelyn, Perualila, Nolen, 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/10362/160869
Resumo: Funding Information: The authors declare that this study was sponsored by Janssen EMEA. The funder had the following involvement in the study: this article was based on the original studies 54135419DEP4001 and ESKETINTRD3004, both sponsored by Janssen EMEA. Support for third-party writing assistance for this article, provided by Julia Stevens, and Emma Phillips, Costello Medical, UK, was funded by Janssen EMEA in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). Funding Information: AJOM received grants from Schuhfried GmBH, Janssen and Compass Pathways, Ltd, payment or honoraria from MSD, Neurolite AG, Janssen, and the European Monitoring Centre for Drugs and Drug Addiction, participated in advisory boards for Janssen and Angelini, investigator-driven research funded by Fundação para Ciência e Tecnologia (PTDC/MED-NEU/31331/2017; PTDC/SAU-NUT/3507/2021; PTDC/MED-NEU/1552/2021), Fundação para Ciência e Tecnologia and FEDER (PTDC/MEC-PSQ/30302/2017_LISBOA-01-0145-FEDER-030845; PTDC/MEC-PSQ/30302/2017_LISBOA-01-0145-FEDER-30302), the European Commission Horizon 2020 program (H2020-SC1-2017-CNECT-2-777167-ΒΟUNCE; H2020-SC1-DTH-2019-875358-FAITH), the European Joint Programme in Rare Diseases (Joint Translational Call 2019) through Fundação para Ciência e Tecnologia (EJPRD/0001/2020) and the European Research Council (grant agreement 950357). JM is a former employee of Janssen EMEA and current employee of AbbVie. BR, YG, JC, NP, and SMH are employees of Janssen EMEA. Publisher Copyright: Copyright © 2023 Oliveira-Maia, Rive, Morrens, Godinov, Cabrieto, Perualila and Mulhern-Haughey.
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spelling Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depressionresults from the ICEBERG studyaugmentationesketamine nasal sprayindirect comparisonpolypharmacyreal-world evidencetreatment resistant depressionPsychiatry and Mental healthSDG 3 - Good Health and Well-beingFunding Information: The authors declare that this study was sponsored by Janssen EMEA. The funder had the following involvement in the study: this article was based on the original studies 54135419DEP4001 and ESKETINTRD3004, both sponsored by Janssen EMEA. Support for third-party writing assistance for this article, provided by Julia Stevens, and Emma Phillips, Costello Medical, UK, was funded by Janssen EMEA in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). Funding Information: AJOM received grants from Schuhfried GmBH, Janssen and Compass Pathways, Ltd, payment or honoraria from MSD, Neurolite AG, Janssen, and the European Monitoring Centre for Drugs and Drug Addiction, participated in advisory boards for Janssen and Angelini, investigator-driven research funded by Fundação para Ciência e Tecnologia (PTDC/MED-NEU/31331/2017; PTDC/SAU-NUT/3507/2021; PTDC/MED-NEU/1552/2021), Fundação para Ciência e Tecnologia and FEDER (PTDC/MEC-PSQ/30302/2017_LISBOA-01-0145-FEDER-030845; PTDC/MEC-PSQ/30302/2017_LISBOA-01-0145-FEDER-30302), the European Commission Horizon 2020 program (H2020-SC1-2017-CNECT-2-777167-ΒΟUNCE; H2020-SC1-DTH-2019-875358-FAITH), the European Joint Programme in Rare Diseases (Joint Translational Call 2019) through Fundação para Ciência e Tecnologia (EJPRD/0001/2020) and the European Research Council (grant agreement 950357). JM is a former employee of Janssen EMEA and current employee of AbbVie. BR, YG, JC, NP, and SMH are employees of Janssen EMEA. Publisher Copyright: Copyright © 2023 Oliveira-Maia, Rive, Morrens, Godinov, Cabrieto, Perualila and Mulhern-Haughey.Background: The efficacy of esketamine nasal spray (NS) as a rapid-acting agent for treatment resistant depression (TRD) was demonstrated in comparisons with placebo, when both were given in addition to a newly initiated selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI). How esketamine NS compares with commonly used real-world (RW) polypharmacy treatment strategies is not known. Method: ICEBERG was an adjusted indirect treatment comparison that analysed data from SUSTAIN-2 (NCT02497287; clinicaltrials.gov), a long-term, open-label study of esketamine NS plus SSRI/SNRI, and the European Observational TRD Cohort (EOTC; NCT03373253; clinicaltrials.gov), an observational study of routine clinical practice. Data were compared between patients receiving esketamine NS (SUSTAIN-2) and those from the EOTC treated with polypharmacy treatment strategies, either combination or augmentation. Analyses were adjusted for potential confounders, using rescaled average treatment effect among treated estimates. Threshold analyses were conducted to assess potential impact of unmeasured confounders on the robustness of analyses where esketamine NS was found to be significantly superior. Sensitivity analyses were used to understand the impact of analysis method selection and data handling. Results: Esketamine NS treatment resulted in a higher probability of 6-month response (49.7% [95% confidence interval (CI) 45.6–53.9]) and remission (33.6% [95% CI 29.7–37.6]) versus RW polypharmacy (26.8% [95% CI 21.0–32.5] and 19.4%, [95% CI 14.2–24.6], respectively). Relative risk calculations showed esketamine NS was 1.859 (95% CI 1.474–2.345; p < 0.0001) times as likely to result in response and 1.735 (1.297–2.322; p = 0.0002) times as likely to result in remission versus RW polypharmacy at 6 months. Threshold and extensive sensitivity analyses supported that analyses of esketamine NS superiority were robust. Conclusion: ICEBERG supports esketamine NS being superior to current RW individualized polypharmacy strategies, including augmentation, with benefits extending beyond acute use, to improved chance of 6-month response and remission. While unobserved confounding factors may certainly impact results of an indirect comparison, threshold analysis supported a low likelihood of this affecting the conclusions. To view an animated summary of this publication, please click on the Supplementary video.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNOliveira-Maia, Albino J.Rive, BenoitMorrens, JoachimGodinov, YordanCabrieto, JedelynPerualila, NolenMulhern-Haughey, Siobhán2023-12-04T22:34:32Z2023-10-312023-10-31T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/160869eng1664-0640PURE: 77652234https://doi.org/10.3389/fpsyt.2023.1250987info: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:RCAAP2024-03-11T05:43:37Zoai:run.unl.pt:10362/160869Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:58:14.925734Repositório 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 Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression
results from the ICEBERG study
title Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression
spellingShingle Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression
Oliveira-Maia, Albino J.
augmentation
esketamine nasal spray
indirect comparison
polypharmacy
real-world evidence
treatment resistant depression
Psychiatry and Mental health
SDG 3 - Good Health and Well-being
title_short Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression
title_full Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression
title_fullStr Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression
title_full_unstemmed Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression
title_sort Indirect adjusted comparison of 6-month clinical outcomes between esketamine nasal spray and other real-world polypharmacy treatment strategies for treatment resistant depression
author Oliveira-Maia, Albino J.
author_facet Oliveira-Maia, Albino J.
Rive, Benoit
Morrens, Joachim
Godinov, Yordan
Cabrieto, Jedelyn
Perualila, Nolen
Mulhern-Haughey, Siobhán
author_role author
author2 Rive, Benoit
Morrens, Joachim
Godinov, Yordan
Cabrieto, Jedelyn
Perualila, Nolen
Mulhern-Haughey, Siobhán
author2_role author
author
author
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, Benoit
Morrens, Joachim
Godinov, Yordan
Cabrieto, Jedelyn
Perualila, Nolen
Mulhern-Haughey, Siobhán
dc.subject.por.fl_str_mv augmentation
esketamine nasal spray
indirect comparison
polypharmacy
real-world evidence
treatment resistant depression
Psychiatry and Mental health
SDG 3 - Good Health and Well-being
topic augmentation
esketamine nasal spray
indirect comparison
polypharmacy
real-world evidence
treatment resistant depression
Psychiatry and Mental health
SDG 3 - Good Health and Well-being
description Funding Information: The authors declare that this study was sponsored by Janssen EMEA. The funder had the following involvement in the study: this article was based on the original studies 54135419DEP4001 and ESKETINTRD3004, both sponsored by Janssen EMEA. Support for third-party writing assistance for this article, provided by Julia Stevens, and Emma Phillips, Costello Medical, UK, was funded by Janssen EMEA in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). Funding Information: AJOM received grants from Schuhfried GmBH, Janssen and Compass Pathways, Ltd, payment or honoraria from MSD, Neurolite AG, Janssen, and the European Monitoring Centre for Drugs and Drug Addiction, participated in advisory boards for Janssen and Angelini, investigator-driven research funded by Fundação para Ciência e Tecnologia (PTDC/MED-NEU/31331/2017; PTDC/SAU-NUT/3507/2021; PTDC/MED-NEU/1552/2021), Fundação para Ciência e Tecnologia and FEDER (PTDC/MEC-PSQ/30302/2017_LISBOA-01-0145-FEDER-030845; PTDC/MEC-PSQ/30302/2017_LISBOA-01-0145-FEDER-30302), the European Commission Horizon 2020 program (H2020-SC1-2017-CNECT-2-777167-ΒΟUNCE; H2020-SC1-DTH-2019-875358-FAITH), the European Joint Programme in Rare Diseases (Joint Translational Call 2019) through Fundação para Ciência e Tecnologia (EJPRD/0001/2020) and the European Research Council (grant agreement 950357). JM is a former employee of Janssen EMEA and current employee of AbbVie. BR, YG, JC, NP, and SMH are employees of Janssen EMEA. Publisher Copyright: Copyright © 2023 Oliveira-Maia, Rive, Morrens, Godinov, Cabrieto, Perualila and Mulhern-Haughey.
publishDate 2023
dc.date.none.fl_str_mv 2023-12-04T22:34:32Z
2023-10-31
2023-10-31T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
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PURE: 77652234
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repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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