Characteristics, treatment, and safety profile in patients with atopic dermatitis based on eligibility for randomized clinical trials: An analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP)
Munera-Campos, Monica (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
González Quesada, Alicia (Hospital Universitario de Gran Canaria Dr. Negrín)
Espasandín Arias, Martina (Complejo Hospitalario Universitario de Pontevedra)
Lasheras-Pérez, Miguel Antonio (Hospital Universitari i Politècnic La Fe (València))
de la Cueva Dovao, Pablo (Hospital Universitario Infanta Leonor)
Montero-Vilchez, Trinidad (Hospital Universitario Virgen de las Nieves (Granada))
Ruíz Villaverde, Ricardo (Hospital Universitario San Cecilio (Granada))
Chicharro Manso, Pablo (Hospital Universitario de la Princesa (Madrid))
Gilaberte, Yolanda (Hospital Universitario Miguel Servet (Saragossa))
Elosua-González, Marta (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Curto-Barredo, Laia (Institut Hospital del Mar d'Investigacions Mèdiques)
Pereyra-Rodríguez, José-Juan (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Silvestre Salvador, Juan Francisco (Hospital General Universitario de Alicante (Alacant, País Valencià))
Batalla, Ana (Complejo Hospitalario Universitario de Pontevedra)
Arias-Santiago, Salvador (Hospital Universitario Virgen de las Nieves (Granada))
Navarro-Triviño, Francisco José (Hospital Universitario San Cecilio (Granada))
Navarro-Bielsa, Alba (Hospital Universitario Miguel Servet (Saragossa))
Roustan Gullón, Gaston (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Bertolin Colilla, Marta (Institut Hospital del Mar d'Investigacions Mèdiques)
Betlloch-Mas, Isabel (Hospital General Universitario de Alicante (Alacant, País Valencià))
Castaño, Irene (Hospital Universitario de Gran Canaria Dr. Negrín)
Couselo-Rodríguez, Carmen (Complejo Hospitalario Universitario de Pontevedra)
Rodríguez Serna, Mercedes (Hospital Universitari i Politècnic La Fe (València))
Sanabria-de la Torre, Raquel (Hospital Universitario Virgen de las Nieves (Granada))
Ruiz Carrascosa, Jose Carlos (Hospital Universitario San Cecilio (Granada))
Sánchez, Javier (Hospital Universitario de la Princesa (Madrid))
Rosell Díaz, Ángel (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Gimenez Arnau, Ana María (Institut Hospital del Mar d'Investigacions Mèdiques)
Martínez-Fernández, Sandra (Complejo Hospitalario Universitario de Pontevedra)
García-Doval, Ignacio (Complexo Hospitalario Universitario de Vigo)
Descalzo-Gallego, Miguel Ángel (Fundación Piel Sana)
Carrascosa, José Manuel (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2025
Resum:	Background: Advanced systemic treatments for moderate to severe atopic dermatitis (AD) have appeared in recent years. The efficacy and safety of these treatments, however, is supported by data from randomized clinical trials (RCTs) involving a highly selected group of patients. This limits the generalizability of trial findings to the broader population of AD patients. Objective: To determine the proportion of patients receiving advanced systemic treatments for AD in routine clinical practice who are underrepresented in RCTs and to 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 one of eight common exclusion factors: age ≥65 years; pregnancy desire, pregnancy, or lactation; uncontrolled hypertension, cardiovascular disease, or diabetes; chronic renal disease; current or past cancer diagnosis; liver disease; history of tuberculosis, human immunodeficiency virus or hepatitis B or C infection; and active or acute infection, including superinfection of AD lesions. Results: Of the 366 patients in BIOBADATOP on advanced systemic treatments for AD in March 2024, 18. 3% would not be eligible to participate in an RCT. Ineligible patients were older and had more comorbidities than eligible patients. Inclusion of an Eczema Area and Severity Index (EASI) score <16 in the sensitivity analysis increased the proportion of ineligible patients to 22. 1%. Janus kinase inhibitors were used less often as a first treatment in RCT-ineligible patients. Serious adverse events were significantly more common in ineligible patients, but this difference was lost after adjusting for age, sex, and comorbidities. Conclusions: Overall, 18. 3% of real-world patients with AD-and 22. 1% of 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.
Nota:	Article que forma part d'una tesi per compendi de publicacions. La data d'embargament que ara consta és provisional i es corregirà o s'eliminarà quan es publiqui la versió de l'editor.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió acceptada per publicar
Matèria:	Atopic dermatitis ; JAK inhibitors ; Biologics ; Prospective cohort ; Inclusion criteria ; Clinical trials ; Safety ; Survival analysis ; Competing risks
Publicat a:	Actas dermo-sifiliográficas, 2025 , ISSN 1578-2190

Disponible a partir de: 2099-01-01

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