Real-world evidence from a European cohort study of patients with treatment resistant depression: Baseline patient characteristics

Heerlein, K.; Young, Allan H.; Otte, C.; Frodl, T.; Degraeve, G.; Hagedoorn, W.; Oliveira Maia, A. J.; Pérez Solá, Victor; Rathod, S.; Rosso, G.; Sierra, Pablo; Morrens, J.; Van Dooren, G.; Gali, Y.; Perugi, G.

Real-world evidence from a European cohort study of patients with treatment resistant depression: Baseline patient characteristics

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dc.contributor.author Heerlein, K.
dc.contributor.author Young, Allan H.
dc.contributor.author Otte, C.
dc.contributor.author Frodl, T.
dc.contributor.author Degraeve, G.
dc.contributor.author Hagedoorn, W.
dc.contributor.author Oliveira Maia, A. J.
dc.contributor.author Pérez Solá, Victor
dc.contributor.author Rathod, S.
dc.contributor.author Rosso, G.
dc.contributor.author Sierra, Pablo
dc.contributor.author Morrens, J.
dc.contributor.author Van Dooren, G.
dc.contributor.author Gali, Y.
dc.contributor.author Perugi, G.
dc.date.accessioned 2021-06-22T06:52:41Z
dc.date.available 2021-06-22T06:52:41Z
dc.date.issued 2021
dc.description.abstract Background: Treatment resistant depression (TRD; failure to respond to ≥2 treatments) affects ~20% of patients with major depressive disorder (MDD). Real-world data could help describe patient characteristics and TRD disease burden, to assess the unmet needs of TRD patients in Europe. Methods: This observational study collected data from adults with moderate to severe TRD initiating a new treatment for depression, according to local standards of care. At baseline, socio-demographic characteristics, medical history, prior and current treatments were recorded. Disease severity, health-related quality of life (HRQoL), functionality and productivity were assessed. Results: Overall, 411 eligible patients were enrolled across seven European countries. Mean (standard deviation [SD]) patient age was 51.0 (10.8) years; 62.3% were female. Long-term sick leave was reported by 19.0% of patients; 30.2% were unemployed. The mean (SD) duration of the current episode was 2.6 (3.9) years. At baseline, mean (SD) HRQoL scores for EuroQoL 5-dimension 5-level (UK tariff) and EQ-Visual Analog Scale were 0.41 (0.25) and 41.1 (18.7), respectively. The Work Productivity and Activity Impairment questionnaire demonstrated mean (SD) absenteeism of 57.0% (44.9%) and presenteeism of 54.7% (29.5%); mean (SD) overall work impairment was 60.5% (29.9%). Limitations: Key limitations are small cohort size, absence of a control group and generalizability to countries with different healthcare models. Conclusions: TRD patients had a high disease burden, low HRQoL and reduced function and productivity, with a substantial proportion unable to work. This demonstrates an unmet treatment need in TRD patients that, if addressed, could reduce the heavy personal and societal burden.
dc.description.sponsorship KH: Employee of Janssen EMEA; AHY: Grants from Janssen; speaker/consultant for Allegan, AstraZeneca, Bionomics, Eli Lilly, Janssen, Johnson & Johnson, Livanova, Lundbeck, Servier, Sumitomo Dainippon Pharma and Sunovion; independent research is funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health; CO: Speaker/consultant for Allergan, Ferring, Fortbildungskolleg, Limes Kliniken, MedOnline, Medical Tribune, Neuraxpharm, Sage Therapeutics, and Stillachhaus; Research funding from Deutsche Forschungsgemeinschaft, German Federal Ministry of Education and Research and European Union; TF: Speaker for Janssen-Cilag and Recordati; GD: Consultant/speaker for AstraZeneca, BMS, Eli Lilly, EuroGenerics, GSK, Janssen, Lundbeck, Pfizer and Sanofi; WH: Consultant for Janssen; AJOM: Grants from Schuhfried GmBH, Janssen and Compass Pathways, Ltd; investigator-driven research funded by Fundação para Ciência e Tecnologia (PTDC/MED-NEU/31331/2017), Fundação para Ciência e Tecnologia and FEDER (FCT-PTDC/MEC-PSQ/30302/2017-IC&DTLISBOA-01-0145-FEDER) and the European Commission Horizon 2020 program (H2020-SC1-2017-CNECT-2-777167-ΒΟUNCE; H2020-SC1-DTH-2019-875358-FAITH); VPS: Consultancy fees, honoraria or grants from AB-Biotics, AstraZeneca, Bristol-Myers-Squibb, CIBERSAM, Esteve, FIS-ISCiii, Janssen, Lundbeck, Otsuka, Pfizer and Servier; SR: Consultancy fees from Janssen, Lundbeck and Otsuka; grants from Janssen; GR: Speaker/consultant for Angelini, Innova Pharma, Janssen, Lundbeck and Otsuka; SP: Speaker/consultant for Angelini, Janssen, Lundbeck and Sanofi; JM: Employee of Janssen EMEA; GVD: Employee of Janssen EMEA; YG: Employee of Janssen EMEA; GP: Grant/research support from Angelini; speaker/consultant for Angelini, Janssen, Lundbeck, Neuraxpharm, Sanofi Aventis.
dc.format.mimetype application/pdf
dc.identifier.citation Heerlein K, Young AH, Otte C, Frodl T, Degraeve G, Hagedoorn W, Oliveira-Maia AJ, Perez Sola V, Rathod S, Rosso G, Sierra P, Morrens J, Van Dooren G, Gali Y, Perugi G. Real-world evidence from a European cohort study of patients with treatment resistant depression: Baseline patient characteristics. J Affect Disord. 2021;283:115-22. DOI: 10.1016/j.jad.2020.11.124
dc.identifier.doi http://dx.doi.org/10.1016/j.jad.2020.11.124
dc.identifier.issn 0165-0327
dc.identifier.uri http://hdl.handle.net/10230/47960
dc.language.iso eng
dc.publisher Elsevier
dc.relation.ispartof J Affect Disord. 2021;283:115-22
dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/777167
dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/875358
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.subject.keyword Disease burden
dc.subject.keyword Health-related quality of life
dc.subject.keyword Major depressive disorder
dc.subject.keyword Observational study
dc.subject.keyword Patient-reported outcomes
dc.subject.keyword Socio-economic status
dc.title Real-world evidence from a European cohort study of patients with treatment resistant depression: Baseline patient characteristics
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/publishedVersion

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