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

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Standard

TREatment of ATopic eczema (TREAT) Registry Taskforce : protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. / Bosma, A. L.; Spuls, P. I.; Garcia-Doval, I.; Naldi, L.; Prieto-Merino, D.; Tesch, F.; Apfelbacher, C. J.; Arents, B. W.M.; Barbarot, S.; Baselga, E.; Deleuran, M.; Eichenfield, L. F.; Gerbens, L. A.A.; Irvine, A. D.; Manca, A.; Mendes-Bastos, P.; Middelkamp-Hup, M. A.; Roberts, A.; Seneschal, J.; Svensson, ; Thyssen, J. P.; Torres, T.; Vermeulen, F. M.; Vestergaard, C.; von Kobyletzki, L. B.; Wall, D.; Weidinger, S.; Schmitt, J.; Flohr, C.

In: British Journal of Dermatology, 2020.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Bosma, AL, Spuls, PI, Garcia-Doval, I, Naldi, L, Prieto-Merino, D, Tesch, F, Apfelbacher, CJ, Arents, BWM, Barbarot, S, Baselga, E, Deleuran, M, Eichenfield, LF, Gerbens, LAA, Irvine, AD, Manca, A, Mendes-Bastos, P, Middelkamp-Hup, MA, Roberts, A, Seneschal, J, Svensson, , Thyssen, JP, Torres, T, Vermeulen, FM, Vestergaard, C, von Kobyletzki, LB, Wall, D, Weidinger, S, Schmitt, J & Flohr, C 2020, 'TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema', British Journal of Dermatology. https://doi.org/10.1111/bjd.18452

APA

Bosma, A. L., Spuls, P. I., Garcia-Doval, I., Naldi, L., Prieto-Merino, D., Tesch, F., ... Flohr, C. (Accepted/In press). TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. British Journal of Dermatology. https://doi.org/10.1111/bjd.18452

Vancouver

Bosma AL, Spuls PI, Garcia-Doval I, Naldi L, Prieto-Merino D, Tesch F 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. British Journal of Dermatology. 2020. https://doi.org/10.1111/bjd.18452

Author

Bosma, A. L. ; Spuls, P. I. ; Garcia-Doval, I. ; Naldi, L. ; Prieto-Merino, D. ; Tesch, F. ; Apfelbacher, C. J. ; Arents, B. W.M. ; Barbarot, S. ; Baselga, E. ; Deleuran, M. ; Eichenfield, L. F. ; Gerbens, L. A.A. ; Irvine, A. D. ; Manca, A. ; Mendes-Bastos, P. ; Middelkamp-Hup, M. A. ; Roberts, A. ; Seneschal, J. ; Svensson, ; Thyssen, J. P. ; Torres, T. ; Vermeulen, F. M. ; Vestergaard, C. ; von Kobyletzki, L. B. ; Wall, D. ; Weidinger, S. ; Schmitt, J. ; Flohr, C. / TREatment of ATopic eczema (TREAT) Registry Taskforce : protocol for a European safety study of dupilumab and other systemic therapies in patients with atopic eczema. In: British Journal of Dermatology. 2020.

Bibtex

@article{350f20e83d6c4d4384d410af37d2980f,
title = "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 characterize fully 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: To 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 another systemic immunomodulating agent for their atopic eczema will be included. The primary end point is the incidence of malignancies (excluding nonmelanoma skin cancer) compared between the treatment groups. Secondary end points 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. What's already known about this topic?. There is a need for long-term data on the safety of systemic immunomodulating therapies in patients with atopic eczema. Regulatory bodies, such as the European Medicines Agency, increasingly stipulate the collection of such data as part of the licensing agreement for new treatments, to assess the new agent's long-term safety profile against established therapies. Large numbers of patients with a long duration of follow-up are necessary in order to detect rare events like malignancies. What does this study add?. The TREAT Registry Taskforce offers a platform to conduct such research with a network of multiple national atopic eczema research registries. We present a protocol for an investigator-initiated multicentre safety study comparing dupilumab with other systemic immunomodulating therapies in adults and subsequently adolescents and children with moderate-to-severe atopic eczema. This protocol can be used as a framework for similar studies for other novel systemic immunomodulating therapies across both adult and paediatric populations.",
author = "Bosma, {A. L.} and Spuls, {P. I.} and I. Garcia-Doval and L. Naldi and D. Prieto-Merino and F. Tesch and Apfelbacher, {C. J.} and Arents, {B. W.M.} and S. Barbarot and E. Baselga and M. Deleuran and Eichenfield, {L. F.} and Gerbens, {L. A.A.} and Irvine, {A. D.} and A. Manca and P. Mendes-Bastos and Middelkamp-Hup, {M. A.} and A. Roberts and J. Seneschal and Svensson and Thyssen, {J. P.} and T. Torres and Vermeulen, {F. M.} and C. Vestergaard and {von Kobyletzki}, {L. B.} and D. Wall and S. Weidinger and J. Schmitt and C. Flohr",
year = "2020",
doi = "10.1111/bjd.18452",
language = "English",
journal = "British Journal of Dermatology",
issn = "0007-0963",
publisher = "Wiley-Blackwell",

}

RIS

TY - JOUR

T1 - TREatment of ATopic eczema (TREAT) Registry Taskforce

T2 - 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, null

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.

PY - 2020

Y1 - 2020

N2 - Background: A long-term prospective observational safety study is essential to characterize fully 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: To 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 another systemic immunomodulating agent for their atopic eczema will be included. The primary end point is the incidence of malignancies (excluding nonmelanoma skin cancer) compared between the treatment groups. Secondary end points 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. What's already known about this topic?. There is a need for long-term data on the safety of systemic immunomodulating therapies in patients with atopic eczema. Regulatory bodies, such as the European Medicines Agency, increasingly stipulate the collection of such data as part of the licensing agreement for new treatments, to assess the new agent's long-term safety profile against established therapies. Large numbers of patients with a long duration of follow-up are necessary in order to detect rare events like malignancies. What does this study add?. The TREAT Registry Taskforce offers a platform to conduct such research with a network of multiple national atopic eczema research registries. We present a protocol for an investigator-initiated multicentre safety study comparing dupilumab with other systemic immunomodulating therapies in adults and subsequently adolescents and children with moderate-to-severe atopic eczema. This protocol can be used as a framework for similar studies for other novel systemic immunomodulating therapies across both adult and paediatric populations.

AB - Background: A long-term prospective observational safety study is essential to characterize fully 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: To 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 another systemic immunomodulating agent for their atopic eczema will be included. The primary end point is the incidence of malignancies (excluding nonmelanoma skin cancer) compared between the treatment groups. Secondary end points 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. What's already known about this topic?. There is a need for long-term data on the safety of systemic immunomodulating therapies in patients with atopic eczema. Regulatory bodies, such as the European Medicines Agency, increasingly stipulate the collection of such data as part of the licensing agreement for new treatments, to assess the new agent's long-term safety profile against established therapies. Large numbers of patients with a long duration of follow-up are necessary in order to detect rare events like malignancies. What does this study add?. The TREAT Registry Taskforce offers a platform to conduct such research with a network of multiple national atopic eczema research registries. We present a protocol for an investigator-initiated multicentre safety study comparing dupilumab with other systemic immunomodulating therapies in adults and subsequently adolescents and children with moderate-to-severe atopic eczema. This protocol can be used as a framework for similar studies for other novel systemic immunomodulating therapies across both adult and paediatric populations.

U2 - 10.1111/bjd.18452

DO - 10.1111/bjd.18452

M3 - Journal article

C2 - 31444799

AN - SCOPUS:85075395023

JO - British Journal of Dermatology

JF - British Journal of Dermatology

SN - 0007-0963

ER -

ID: 238963318