Observational 24‐week study to assess clinical response to upadacitinib posttrial in patients with moderate‐to‐severe atopic dermatitis

Abstract Background The oral anti‐janus kinase 1 inhibitor upadacitinib has shown a good efficacy–safety profile in the treatment of moderate‐to‐severe atopic dermatitis (AD) in clinical trials; however, few data from real clinical practice have been published so far. Objectives To evaluate the effi...

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Main Authors: Ana Batalla, Hae Jin Suh‐Oh, Gregorio Carretero Hernández, Javier Miquel‐Miquel, Rafael Botella‐Estrada, Antonio Martorell‐Calatayud, Virginia Sanz‐Motilva, Ignasi Figueras‐Nart, Angeles Flórez
Format: Article
Language:English
Published: Wiley 2023-09-01
Series:JEADV Clinical Practice
Subjects:
Online Access:https://doi.org/10.1002/jvc2.179
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author Ana Batalla
Hae Jin Suh‐Oh
Gregorio Carretero Hernández
Javier Miquel‐Miquel
Rafael Botella‐Estrada
Antonio Martorell‐Calatayud
Virginia Sanz‐Motilva
Ignasi Figueras‐Nart
Angeles Flórez
author_facet Ana Batalla
Hae Jin Suh‐Oh
Gregorio Carretero Hernández
Javier Miquel‐Miquel
Rafael Botella‐Estrada
Antonio Martorell‐Calatayud
Virginia Sanz‐Motilva
Ignasi Figueras‐Nart
Angeles Flórez
author_sort Ana Batalla
collection DOAJ
description Abstract Background The oral anti‐janus kinase 1 inhibitor upadacitinib has shown a good efficacy–safety profile in the treatment of moderate‐to‐severe atopic dermatitis (AD) in clinical trials; however, few data from real clinical practice have been published so far. Objectives To evaluate the efficacy and safety of upadactinib in clinical practice. Methods An observational and multicentric study was conducted. Inclusion criteria consisted of patients who had previously received upadacitinib in the clinical trial M19‐850 and continued treatment with upadacitinib (15 mg or 30 mg) under daily clinical practice conditions for 12 months. Demographic data, characteristics of AD, treatment response and adverse events were recorded. Preliminary results at 24‐week follow‐up are herein presented. Results A total of 26 patients (61.54% males, mean age: 35.58 years) were included in the study; of these, 92.31% received upadacitinib 30 mg at baseline. At 24 weeks, mean values of Eczema Area and Severity Index and body surface area were 2.26 and 2.37%, respectively, 82.35% of the patients reached the Investigator's Global Assessment 0/1 and the mean value of peak pruritus numerical rating scale was 1.74. Adverse events were present in 19.23% of the cases, causing one definitive treatment interruption (due to herpes zoster) and two temporary treatment discontinuations (due to temporary elevation of creatine kinase). Conclusions These data support the maintenance of the efficacy of upadacitinib at 24‐week posttrial follow‐up, with no unexpected safety concerns. More real‐world data are needed to confirm these results.
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spelling doaj.art-caf7bdc22b8e476da504589f4a201ee52023-09-01T12:30:54ZengWileyJEADV Clinical Practice2768-65662023-09-012357157510.1002/jvc2.179Observational 24‐week study to assess clinical response to upadacitinib posttrial in patients with moderate‐to‐severe atopic dermatitisAna Batalla0Hae Jin Suh‐Oh1Gregorio Carretero Hernández2Javier Miquel‐Miquel3Rafael Botella‐Estrada4Antonio Martorell‐Calatayud5Virginia Sanz‐Motilva6Ignasi Figueras‐Nart7Angeles Flórez8Dermatology Department Complejo Hospitalario Universitario de Pontevedra, Sergas Pontevedra SpainDermatology Department Complejo Hospitalario Universitario de Pontevedra, Sergas Pontevedra SpainDermatology Department Hospital Universitario de Gran Canaria Dr. Negrín Gran Canaria SpainDermatology Department Hospital Universitario Arnau de Vilanova Valencia SpainDermatology Department Hospital Universitario y Politécnico La Fe Valencia SpainDermatology Department Hospital de Manises Valencia SpainDermatology Department Hospital de Manises Valencia SpainDermatology Department Hospital Universitario de Bellvitge Barcelona SpainDermatology Department Complejo Hospitalario Universitario de Pontevedra, Sergas Pontevedra SpainAbstract Background The oral anti‐janus kinase 1 inhibitor upadacitinib has shown a good efficacy–safety profile in the treatment of moderate‐to‐severe atopic dermatitis (AD) in clinical trials; however, few data from real clinical practice have been published so far. Objectives To evaluate the efficacy and safety of upadactinib in clinical practice. Methods An observational and multicentric study was conducted. Inclusion criteria consisted of patients who had previously received upadacitinib in the clinical trial M19‐850 and continued treatment with upadacitinib (15 mg or 30 mg) under daily clinical practice conditions for 12 months. Demographic data, characteristics of AD, treatment response and adverse events were recorded. Preliminary results at 24‐week follow‐up are herein presented. Results A total of 26 patients (61.54% males, mean age: 35.58 years) were included in the study; of these, 92.31% received upadacitinib 30 mg at baseline. At 24 weeks, mean values of Eczema Area and Severity Index and body surface area were 2.26 and 2.37%, respectively, 82.35% of the patients reached the Investigator's Global Assessment 0/1 and the mean value of peak pruritus numerical rating scale was 1.74. Adverse events were present in 19.23% of the cases, causing one definitive treatment interruption (due to herpes zoster) and two temporary treatment discontinuations (due to temporary elevation of creatine kinase). Conclusions These data support the maintenance of the efficacy of upadacitinib at 24‐week posttrial follow‐up, with no unexpected safety concerns. More real‐world data are needed to confirm these results.https://doi.org/10.1002/jvc2.179atopic dermatitistreatmentupadacitinib
spellingShingle Ana Batalla
Hae Jin Suh‐Oh
Gregorio Carretero Hernández
Javier Miquel‐Miquel
Rafael Botella‐Estrada
Antonio Martorell‐Calatayud
Virginia Sanz‐Motilva
Ignasi Figueras‐Nart
Angeles Flórez
Observational 24‐week study to assess clinical response to upadacitinib posttrial in patients with moderate‐to‐severe atopic dermatitis
JEADV Clinical Practice
atopic dermatitis
treatment
upadacitinib
title Observational 24‐week study to assess clinical response to upadacitinib posttrial in patients with moderate‐to‐severe atopic dermatitis
title_full Observational 24‐week study to assess clinical response to upadacitinib posttrial in patients with moderate‐to‐severe atopic dermatitis
title_fullStr Observational 24‐week study to assess clinical response to upadacitinib posttrial in patients with moderate‐to‐severe atopic dermatitis
title_full_unstemmed Observational 24‐week study to assess clinical response to upadacitinib posttrial in patients with moderate‐to‐severe atopic dermatitis
title_short Observational 24‐week study to assess clinical response to upadacitinib posttrial in patients with moderate‐to‐severe atopic dermatitis
title_sort observational 24 week study to assess clinical response to upadacitinib posttrial in patients with moderate to severe atopic dermatitis
topic atopic dermatitis
treatment
upadacitinib
url https://doi.org/10.1002/jvc2.179
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