Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)

Background: Randomized clinical trials (RCTs) supporting advanced treatments for atopic dermatitis (AD) involve highly selected patients, limiting their generalizability. Objective: To determine the proportion of adults on advanced systemic therapy for AD in clinical practice who are underrepresente...

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Autores: Munuera Campos, M, González Quesada, A, Espasandin Arias, M, Lasheras Pérez, M.A, Cueva Dovao, P de la, Montero Vilchez. T, Pereyra-Rodríguez, José-Juan
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/181635
Acceso en línea:https://hdl.handle.net/11441/181635
https://doi.org/10.1016/j.ad.2025.104489
Access Level:acceso abierto
Palabra clave:topic dermatitis
Biologics
Clinical trials
Inclusion criteria
JAK inhibitors
Prospective cohort
Safety
Survival analysis
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spelling Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)Munuera Campos, MGonzález Quesada, AEspasandin Arias, MLasheras Pérez, M.ACueva Dovao, P de laMontero Vilchez. TPereyra-Rodríguez, José-Juantopic dermatitisBiologicsClinical trialsInclusion criteriaJAK inhibitorsProspective cohortSafetySurvival analysisBackground: Randomized clinical trials (RCTs) supporting advanced treatments for atopic dermatitis (AD) involve highly selected patients, limiting their generalizability. Objective: To determine the proportion of adults on advanced systemic therapy for AD in clinical practice who are underrepresented in RCTs and compare the safety and drug survival of these treatments between RCT-eligible and RCT-ineligible patients. Material and methods: Descriptive and comparative analysis of data from the Spanish Atopic Dermatitis registry BIOBADATOP. Patients were deemed RCT-ineligible if they met, at least, 1 of 8 common exclusion factors: age≥65 years; pregnancy desire pregnancy or lactation; uncontrolled hypertension, cardiovascular disease, or diabetes; chronic kidney disease; cancer diagnosis; liver disease; history of tuberculosis, human immunodeficiency virus or hepatitis B or C infection; and active or acute infection. Results: Of the 366 adults in BIOBADATOP on advanced systemic therapies for AD, 18.3% would be considered ineligible to participate in RCTs. Ineligible patients were older and had more comorbidities than eligible patients. Inclusion of an EASI score<16 at baseline in the sensitivity analysis increased the proportion of ineligible patients to 37.2%. Janus kinase inhibitors were used less often as a first-line therapy in RCT-ineligible patients. Although serious adverse events were significantly more common in ineligible patients, this difference was lost after adjusting for age, sex, and comorbidities. Conclusions: Overall, 18.3% of real-world patients with AD-and 37.2% including those with EASI<16-are underrepresented in RCTs. Age and comorbidities influence safety outcomes and should be considered when taking treatment decisions and designing RCTs.ElsevierMedicina2025info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/181635https://doi.org/10.1016/j.ad.2025.104489reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésActas dermo-sifiliograficas, 117 (1), 104489.https://www.sciencedirect.com/science/article/pii/S0001731025007586?via%3Dihubinfo:eu-repo/semantics/openAccessoai:idus.us.es:11441/1816352026-06-17T12:51:07Z
dc.title.none.fl_str_mv Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)
title Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)
spellingShingle Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)
Munuera Campos, M
topic dermatitis
Biologics
Clinical trials
Inclusion criteria
JAK inhibitors
Prospective cohort
Safety
Survival analysis
title_short Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)
title_full Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)
title_fullStr Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)
title_full_unstemmed Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)
title_sort Characteristics, treatment, and safety profile of patients with atopic dermatitis according to eligibility for randomized clinical trials: an analysis from the Spanish Atopic Dermatitis Registry (BIOBADATOP)
dc.creator.none.fl_str_mv Munuera Campos, M
González Quesada, A
Espasandin Arias, M
Lasheras Pérez, M.A
Cueva Dovao, P de la
Montero Vilchez. T
Pereyra-Rodríguez, José-Juan
author Munuera Campos, M
author_facet Munuera Campos, M
González Quesada, A
Espasandin Arias, M
Lasheras Pérez, M.A
Cueva Dovao, P de la
Montero Vilchez. T
Pereyra-Rodríguez, José-Juan
author_role author
author2 González Quesada, A
Espasandin Arias, M
Lasheras Pérez, M.A
Cueva Dovao, P de la
Montero Vilchez. T
Pereyra-Rodríguez, José-Juan
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
dc.subject.none.fl_str_mv topic dermatitis
Biologics
Clinical trials
Inclusion criteria
JAK inhibitors
Prospective cohort
Safety
Survival analysis
topic topic dermatitis
Biologics
Clinical trials
Inclusion criteria
JAK inhibitors
Prospective cohort
Safety
Survival analysis
description Background: Randomized clinical trials (RCTs) supporting advanced treatments for atopic dermatitis (AD) involve highly selected patients, limiting their generalizability. Objective: To determine the proportion of adults on advanced systemic therapy for AD in clinical practice who are underrepresented in RCTs and compare the safety and drug survival of these treatments between RCT-eligible and RCT-ineligible patients. Material and methods: Descriptive and comparative analysis of data from the Spanish Atopic Dermatitis registry BIOBADATOP. Patients were deemed RCT-ineligible if they met, at least, 1 of 8 common exclusion factors: age≥65 years; pregnancy desire pregnancy or lactation; uncontrolled hypertension, cardiovascular disease, or diabetes; chronic kidney disease; cancer diagnosis; liver disease; history of tuberculosis, human immunodeficiency virus or hepatitis B or C infection; and active or acute infection. Results: Of the 366 adults in BIOBADATOP on advanced systemic therapies for AD, 18.3% would be considered ineligible to participate in RCTs. Ineligible patients were older and had more comorbidities than eligible patients. Inclusion of an EASI score<16 at baseline in the sensitivity analysis increased the proportion of ineligible patients to 37.2%. Janus kinase inhibitors were used less often as a first-line therapy in RCT-ineligible patients. Although serious adverse events were significantly more common in ineligible patients, this difference was lost after adjusting for age, sex, and comorbidities. Conclusions: Overall, 18.3% of real-world patients with AD-and 37.2% including those with EASI<16-are underrepresented in RCTs. Age and comorbidities influence safety outcomes and should be considered when taking treatment decisions and designing RCTs.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/181635
https://doi.org/10.1016/j.ad.2025.104489
url https://hdl.handle.net/11441/181635
https://doi.org/10.1016/j.ad.2025.104489
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Actas dermo-sifiliograficas, 117 (1), 104489.
https://www.sciencedirect.com/science/article/pii/S0001731025007586?via%3Dihub
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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