Methodology of the brodalumab assessment of hazards: A multicentre observational safety (BRAHMS) study

  1. Reilev, Mette ORCID logo
  2. Jensen, Peter Bjødstrup
  3. Ranch, Lise Skov ORCID logo
  4. Egeberg, Alexander ORCID logo
  5. Furu, Kari
  6. Gembert, Karin
  7. Hägg, David
  8. Haug, Ulrike ORCID logo
  9. Karlstad, Øystein
  10. Reutfors, Johan
  11. Schäfer, Wiebke ORCID logo
  12. Schwarz, Sarina ORCID logo
  13. Smits, Elisabeth
  14. Holthuis, Emily
  15. Herings, Ron
  16. Trifirò, Gianluca
  17. Kirchmayer, Ursula
  18. Cesare Rosa, Alessandro
  19. Belleudi, Valeria
  20. Gini, Rosa ORCID logo
  21. Støvring Henrik
  22. Hallas, Jesper

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Reilev-et-al_2023_Methodology of the brodalumab assessment of hazards.pdf 965,04KB
WeightNameValue
1000 Titel
  • Methodology of the brodalumab assessment of hazards: A multicentre observational safety (BRAHMS) study
1000 Autor/in
  1. Reilev, Mette |
  2. Jensen, Peter Bjødstrup |
  3. Ranch, Lise Skov |
  4. Egeberg, Alexander |
  5. Furu, Kari |
  6. Gembert, Karin |
  7. Hägg, David |
  8. Haug, Ulrike |
  9. Karlstad, Øystein |
  10. Reutfors, Johan |
  11. Schäfer, Wiebke |
  12. Schwarz, Sarina |
  13. Smits, Elisabeth |
  14. Holthuis, Emily |
  15. Herings, Ron |
  16. Trifirò, Gianluca |
  17. Kirchmayer, Ursula |
  18. Cesare Rosa, Alessandro |
  19. Belleudi, Valeria |
  20. Gini, Rosa |
  21. Støvring Henrik |
  22. Hallas, Jesper |
1000 Erscheinungsjahr 2023
1000 LeibnizOpen
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2023-02-01
1000 Erschienen in
1000 Quellenangabe
  • 13(2):e066057
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2023
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1136/bmjopen-2022-066057 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9896233/ |
1000 Ergänzendes Material
  • https://bmjopen.bmj.com/content/13/2/e066057#supplementary-materials |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • INTRODUCTION: Safe and effective pharmacological treatment is of paramount importance for treating severe psoriasis. Brodalumab, a monoclonal antibody against interleukin (IL) 17 receptor A, was granted marketing authorisation in the EU in 2017. The European Medicines Agency requested a postauthorisation safety study of brodalumab to address potential safety issues raised during drug development regarding major adverse cardiovascular events, suicidal conduct, cancer and serious infections. METHODS AND ANALYSIS: Brodalumab Assessment of Hazards: A Multinational Safety is a multicentre observational safety study of brodalumab running from 2017 to 2029 using population-based healthcare databases from Denmark, Sweden, Norway, Netherlands, Germany and three different centres in Italy. A distributed database network approach is used, such that only aggregate data are exchanged between sites. Two types of designs are used: a case-time-control design to study acute effects of transient treatment and a variation of the new user active comparator design to study the effects of transient or chronic treatment. As comparators, inhibitors of TNF-α, inhibitors of IL-12 and IL-23, and other inhibitors of cytokine IL-17A are included. In the self-controlled case-time-control design, the risk of developing the outcome of interest during periods of brodalumab use is compared within individuals to the risk in periods without use. In the active comparator cohort design, new users of brodalumab are identified and matched to new users of active comparators. Potential baseline confounders are adjusted for by using propensity score modelling. For outcomes that potentially require large cumulative exposure, an adapted active comparator design has been developed. ETHICS AND DISSEMINATION: The study is approved by relevant authorities in Denmark, Norway, Sweden, the Netherlands, Germany and Italy in line with the relevant legislation at each site. Data confidentiality is secured by the distributed network approach. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: EUPAS30280.
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0003-1241-4385|https://frl.publisso.de/adhoc/uri/SmVuc2VuLCBQZXRlciBCasO4ZHN0cnVw|https://orcid.org/0000-0002-6029-2215|https://orcid.org/0000-0001-8257-1816|https://frl.publisso.de/adhoc/uri/RnVydSwgS2FyaQ==|https://frl.publisso.de/adhoc/uri/R2VtYmVydCwgS2FyaW4=|https://frl.publisso.de/adhoc/uri/SMOkZ2csIERhdmlk|https://orcid.org/0000-0002-1886-2923|https://frl.publisso.de/adhoc/uri/S2FybHN0YWQsIMOYeXN0ZWlu|https://frl.publisso.de/adhoc/uri/UmV1dGZvcnMsIEpvaGFu|https://orcid.org/0000-0002-8284-448X|https://orcid.org/0000-0002-7926-2032|https://frl.publisso.de/adhoc/uri/U21pdHMsIEVsaXNhYmV0aA==|https://frl.publisso.de/adhoc/uri/SG9sdGh1aXMsIEVtaWx5|https://frl.publisso.de/adhoc/uri/SGVyaW5ncywgUm9u|https://frl.publisso.de/adhoc/uri/VHJpZmlyw7IsIEdpYW5sdWNh|https://frl.publisso.de/adhoc/uri/S2lyY2htYXllciwgVXJzdWxh|https://frl.publisso.de/adhoc/uri/Q2VzYXJlIFJvc2EsIEFsZXNzYW5kcm8=|https://frl.publisso.de/adhoc/uri/QmVsbGV1ZGksIFZhbGVyaWE=|https://orcid.org/0000-0002-6250-877X|https://frl.publisso.de/adhoc/uri/U3TDuHZyaW5nIEhlbnJpaw==|https://frl.publisso.de/adhoc/uri/SGFsbGFzLCBKZXNwZXI=
1000 Label
1000 Förderer
  1. LEO Pharma |
1000 Fördernummer
  1. -
1000 Förderprogramm
  1. -
1000 Dateien
  1. Methodology of the brodalumab assessment of hazards: a multicentre observational safety (BRAHMS) study
    Methodology of the brodalumab assessment of hazards: a multicentre observational safety (BRAHMS) study
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer LEO Pharma |
    1000 Förderprogramm -
    1000 Fördernummer -
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6452530.rdf
1000 Erstellt am 2023-05-15T09:26:32.099+0200
1000 Erstellt von 266
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1000 Bearbeitet von 317
1000 Zuletzt bearbeitet Mon Jun 12 08:24:38 CEST 2023
1000 Objekt bearb. Mon Jun 12 08:24:26 CEST 2023
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  1. oai:frl.publisso.de:frl:6452530 |
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