Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients

<b>Background</b>: Atopic dermatitis (AD) is an inflammatory skin disease characterized by a wide phenotypic variety with a very complex pathophysiological mechanism that has led to the identification of new therapeutic targets, such as janus kinasis (JAK) inhibitors. <b>Objectives...

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Autores principales:	Giulia Radi, Oriana Simonetti, Giulio Rizzetto, Federico Diotallevi, Elisa Molinelli, Annamaria Offidani
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	atopic dermatitis baricitinib JAK inhibitors efficacy safety Medicine R
Acceso en línea:	https://doaj.org/article/5c029ab8ce6f4339b211259eed29fb6f
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spelling	oai:doaj.org-article:5c029ab8ce6f4339b211259eed29fb6f2021-11-25T17:46:33ZBaricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients10.3390/healthcare91115752227-9032https://doaj.org/article/5c029ab8ce6f4339b211259eed29fb6f2021-11-01T00:00:00Zhttps://www.mdpi.com/2227-9032/9/11/1575https://doaj.org/toc/2227-9032<b>Background</b>: Atopic dermatitis (AD) is an inflammatory skin disease characterized by a wide phenotypic variety with a very complex pathophysiological mechanism that has led to the identification of new therapeutic targets, such as janus kinasis (JAK) inhibitors. <b>Objectives</b>: To evaluate the efficacy and safety of baricitinib, the first JAK 1 and 2 inhibitor approved in Europe for the treatment of adult patients with moderate-to-severe AD. <b>Methods</b>: The efficacy and safety data available from the Phase III studies belonging to the BREEZE AD program are presented. <b>Results:</b> Results from BREEZE-AD1, AD2, AD4, and AD7 showed the efficacy of Baricitib 4 mg, administered orally, once daily, as monotherapy or in combination with topical corticosteroid (TCS), with a significant proportion of patients achieving primary endpoints IGA 0–1 (16.4% vs. 4.8%; 13.8% vs. 4.5%; 21.7% vs. 9.7%; 30.6% vs. 14.7%) and EASI75 (24.8% vs. 8.8%; 21.1% vs. 6.1%; 31.5% vs. 17.2%; 47.7% vs. 22.9%) at week 16 (W16) compared to placebo, respectively. Baricitinib showed rapid improvement in symptoms, starting from week 1 of treatment at 4 mg dosage, with a good safety profile. Nasopharyngitis, upper respiratory tract infections (URIs), creatine phosphokinase (CPK) elevations, and headache were the most frequently reported adverse events. <b>Conclusions</b>: Following the efficacy and safety data on W 16 from the phase III BREEZE-AD studies, baricitinib has recently been approved in Europe for the treatment of moderate to severe AD in adult patients. Further data to evaluate long-term efficacy and safety in a real-life setting are needed.Giulia RadiOriana SimonettiGiulio RizzettoFederico DiotalleviElisa MolinelliAnnamaria OffidaniMDPI AGarticleatopic dermatitisbaricitinibJAK inhibitorsefficacysafetyMedicineRENHealthcare, Vol 9, Iss 1575, p 1575 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	atopic dermatitis baricitinib JAK inhibitors efficacy safety Medicine R
spellingShingle	atopic dermatitis baricitinib JAK inhibitors efficacy safety Medicine R Giulia Radi Oriana Simonetti Giulio Rizzetto Federico Diotallevi Elisa Molinelli Annamaria Offidani Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients
description	<b>Background</b>: Atopic dermatitis (AD) is an inflammatory skin disease characterized by a wide phenotypic variety with a very complex pathophysiological mechanism that has led to the identification of new therapeutic targets, such as janus kinasis (JAK) inhibitors. <b>Objectives</b>: To evaluate the efficacy and safety of baricitinib, the first JAK 1 and 2 inhibitor approved in Europe for the treatment of adult patients with moderate-to-severe AD. <b>Methods</b>: The efficacy and safety data available from the Phase III studies belonging to the BREEZE AD program are presented. <b>Results:</b> Results from BREEZE-AD1, AD2, AD4, and AD7 showed the efficacy of Baricitib 4 mg, administered orally, once daily, as monotherapy or in combination with topical corticosteroid (TCS), with a significant proportion of patients achieving primary endpoints IGA 0–1 (16.4% vs. 4.8%; 13.8% vs. 4.5%; 21.7% vs. 9.7%; 30.6% vs. 14.7%) and EASI75 (24.8% vs. 8.8%; 21.1% vs. 6.1%; 31.5% vs. 17.2%; 47.7% vs. 22.9%) at week 16 (W16) compared to placebo, respectively. Baricitinib showed rapid improvement in symptoms, starting from week 1 of treatment at 4 mg dosage, with a good safety profile. Nasopharyngitis, upper respiratory tract infections (URIs), creatine phosphokinase (CPK) elevations, and headache were the most frequently reported adverse events. <b>Conclusions</b>: Following the efficacy and safety data on W 16 from the phase III BREEZE-AD studies, baricitinib has recently been approved in Europe for the treatment of moderate to severe AD in adult patients. Further data to evaluate long-term efficacy and safety in a real-life setting are needed.
format	article
author	Giulia Radi Oriana Simonetti Giulio Rizzetto Federico Diotallevi Elisa Molinelli Annamaria Offidani
author_facet	Giulia Radi Oriana Simonetti Giulio Rizzetto Federico Diotallevi Elisa Molinelli Annamaria Offidani
author_sort	Giulia Radi
title	Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients
title_short	Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients
title_full	Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients
title_fullStr	Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients
title_full_unstemmed	Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients
title_sort	baricitinib: the first jak inhibitor approved in europe for the treatment of moderate to severe atopic dermatitis in adult patients
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/5c029ab8ce6f4339b211259eed29fb6f
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Baricitinib: The First Jak Inhibitor Approved in Europe for the Treatment of Moderate to Severe Atopic Dermatitis in Adult Patients

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