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TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema.

Abstract

BACKGROUND

A long-term prospective observational safety study is essential to fully characterize the safety profile of systemic immunomodulating therapies for patients with atopic eczema. The TREatment of ATopic eczema (TREAT) Registry Taskforce offers a large platform to conduct such research using national registries that collect the same data using a predefined core dataset.

OBJECTIVES

We present a protocol for a safety study comparing dupilumab with other systemic immunomodulating therapies in children and adults with moderate-to-severe atopic eczema to assess the long-term safety risk of these therapies in a routine clinical care setting.

METHODS

We describe a registry-embedded international observational prospective cohort study. Adult and paediatric patients who start treatment with dupilumab or anothersystemic immunomodulating agent for their atopic eczema will be included. The primary endpoint is the incidence of malignancies (excluding non-melanoma skin cancer) compared between the treatment groups. Secondary endpoints include other serious adverse events and adverse events of special interest, such as eye disorders and eosinophilia.

CONCLUSIONS

This protocol delineates a safety study for dupilumab in adult and paediatric patients with atopic eczema, using a standardized methodological approach across several national registries. The protocol could also be used for other novel systemic immunomodulating therapies and could provide licensing and reimbursement authorities, pharmaceutical companies and clinicians with safety evidence from a routine clinical care setting. This article is protected by copyright. All rights reserved.

Authors+Show Affiliations

Amsterdam UMC, location AMC, University of Amsterdam, Department of Dermatology, Amsterdam Public health, Infection and Immunity, The Netherlands.Amsterdam UMC, location AMC, University of Amsterdam, Department of Dermatology, Amsterdam Public health, Infection and Immunity, The Netherlands.Research Unit, Academia Española de Dermatología y Venereología, Madrid, Spain. Dermatology Department, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.Centro Studi GISED, Bergamo, Italy.Applied Statistics in Medical Research Group, Catholic University of Murcia (UCAM), Murcia, Spain. Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.Center for Evidence-based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.Dutch Association for People with Atopic Dermatitis, Nijkerk, the Netherlands.Department of Dermatology, CHU Nantes, Nantes, France.Department of Dermatology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.Department of Dermatology and Pediatrics, University of California, San Diego, USA.Amsterdam UMC, location AMC, University of Amsterdam, Department of Dermatology, Amsterdam Public health, Infection and Immunity, The Netherlands.Department of Clinical Medicine, Trinity College Dublin, Dublin, Ireland. National Children's Research Centre, Dublin, Ireland. Department of Paediatric Dermatology, Our Lady's Children's Hospital, Dublin, Ireland.Centre for Health Economics, University of York, York, UK.Dermatology Centre, Hospital CUF Descobertas. Lisboa, Portugal.Amsterdam UMC, location AMC, University of Amsterdam, Department of Dermatology, Amsterdam Public health, Infection and Immunity, The Netherlands.Nottingham Support Group for Carers of Children with Eczema, Nottingham, UK.Department of Dermatology and Pediatric Dermatology, National Reference Center for Rare Skin Diseases, University Hospital of Bordeaux, France.Department of Dermatology and Venereology, Skane University Hospital, Malmö, Sweden.Department of Dermatology and Allergy, Herlev-Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.Department of Dermatology, Centro Hospitalar Universitário Porto, Porto, Portugal.Amsterdam UMC, location AMC, University of Amsterdam, Department of Dermatology, Amsterdam Public health, Infection and Immunity, The Netherlands.Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.Centrum for clinical research, Lund University, Malmö, Sweden. Centrum for clinical research, Örebro University, Örebro, Sweden.St James's Hospital, Dublin, Ireland. Irish Skin Foundation, Ireland.Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.Center for Evidence-based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany. University Allergy Center, University Hospital Carl Gustav Carus, Dresden, Germany.Unit for Population-Based Dermatology Research, St John's Institute of Dermatology, Guy's& St Thomas' NHS Foundation Trust and King's College London, London, UK.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31444799

Citation

Bosma, A L., et al. "TREatment of ATopic Eczema (TREAT) Registry Taskforce: Protocol for a European Safety Study of Dupilumab and Other Systemic Therapies in Patients With Atopic Eczema." The British Journal of Dermatology, 2019.
Bosma AL, Spuls PI, Garcia-Doval I, et al. TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. Br J Dermatol. 2019.
Bosma, A. L., Spuls, P. I., Garcia-Doval, I., Naldi, L., Prieto-Merino, D., Tesch, F., ... Flohr, C. (2019). TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. The British Journal of Dermatology, doi:10.1111/bjd.18452.
Bosma AL, et al. TREatment of ATopic Eczema (TREAT) Registry Taskforce: Protocol for a European Safety Study of Dupilumab and Other Systemic Therapies in Patients With Atopic Eczema. Br J Dermatol. 2019 Aug 24; PubMed PMID: 31444799.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. AU - Bosma,A L, AU - Spuls,P I, AU - Garcia-Doval,I, AU - Naldi,L, AU - Prieto-Merino,D, AU - Tesch,F, AU - Apfelbacher,C J, AU - Arents,B W M, AU - Barbarot,S, AU - Baselga,E, AU - Deleuran,M, AU - Eichenfield,L F, AU - Gerbens,L A A, AU - Irvine,A D, AU - Manca,A, AU - Mendes-Bastos,P, AU - Middelkamp-Hup,M A, AU - Roberts,A, AU - Seneschal,J, AU - Svensson,Å, AU - Thyssen,J P, AU - Torres,T, AU - Vermeulen,F M, AU - Vestergaard,C, AU - von Kobyletzki,L B, AU - Wall,D, AU - Weidinger,S, AU - Schmitt,J, AU - Flohr,C, Y1 - 2019/08/24/ PY - 2019/8/25/entrez JF - The British journal of dermatology JO - Br. J. Dermatol. N2 - BACKGROUND: A long-term prospective observational safety study is essential to fully characterize the safety profile of systemic immunomodulating therapies for patients with atopic eczema. The TREatment of ATopic eczema (TREAT) Registry Taskforce offers a large platform to conduct such research using national registries that collect the same data using a predefined core dataset. OBJECTIVES: We present a protocol for a safety study comparing dupilumab with other systemic immunomodulating therapies in children and adults with moderate-to-severe atopic eczema to assess the long-term safety risk of these therapies in a routine clinical care setting. METHODS: We describe a registry-embedded international observational prospective cohort study. Adult and paediatric patients who start treatment with dupilumab or anothersystemic immunomodulating agent for their atopic eczema will be included. The primary endpoint is the incidence of malignancies (excluding non-melanoma skin cancer) compared between the treatment groups. Secondary endpoints include other serious adverse events and adverse events of special interest, such as eye disorders and eosinophilia. CONCLUSIONS: This protocol delineates a safety study for dupilumab in adult and paediatric patients with atopic eczema, using a standardized methodological approach across several national registries. The protocol could also be used for other novel systemic immunomodulating therapies and could provide licensing and reimbursement authorities, pharmaceutical companies and clinicians with safety evidence from a routine clinical care setting. This article is protected by copyright. All rights reserved. SN - 1365-2133 UR - https://www.unboundmedicine.com/medline/citation/31444799/TREatment_of_ATopic_eczema_(TREAT)_Registry_Taskforce:_protocol_for_a_European_safety_study_of_dupilumab_and_other_systemic_therapies_in_patients_with_atopic_eczema L2 - https://doi.org/10.1111/bjd.18452 DB - PRIME DP - Unbound Medicine ER -