Skip to main content
Top
Published in: Dermatology and Therapy 2/2023

Open Access 09-01-2023 | Atopic Dermatitis | Brief Report

Real-Life Effectiveness and Safety of Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A Single-Center 16-Week Study

Authors: Luigi Gargiulo, Luciano Ibba, Andrea Cortese, Jessica Avagliano, Mario Valenti, Antonio Costanzo, Alessandra Narcisi

Published in: Dermatology and Therapy | Issue 2/2023

Login to get access

Abstract

Introduction

The treatment of severe atopic dermatitis (AD) includes cyclosporine and recently approved biologics and small molecules. Among these, upadacitinib is a selective inhibitor of Janus kinase 1, approved for the treatment of severe AD in adolescents/adults. Upadacitinib has shown efficacy and safety in several phase 3 clinical trials, but data on real-life patients are still lacking.

Methods

We conducted a retrospective real-life observational study to evaluate the effectiveness and safety of upadacitinib up to week 16 in a cohort of both bio-naïve and bio-experienced patients. This study was carried out by analyzing the AD database records of an Italian referral hospital. Thirty-eight patients were included in this study, and 35 completed 16 weeks of treatment.

Results

At week 16, out of 35 patients, the percentages of Eczema Area and Severity Index (EASI) 50, EASI 75, EASI 90 and EASI 100 responses were 94.29, 91.43, 74.29, and 60%, respectively. A decrease of at least 4 points from baseline of itch-NRS was reported by 94.74 and 91.43% of patients at weeks 8 and 16. Regarding the safety of upadacitinib, 26.32% of patients experienced at least one adverse event (AE), and a total of 13 AEs were recorded, including blood test abnormalities and papulopustular acne. None of our patients interrupted the drug because of an AE.

Conclusions

We observed higher rates of EASI75/EASI90/EASI100 responses at week 16, compared with data from clinical trials. The safety profile of upadacitinib was favorable, as no AEs leading to discontinuation were experienced by our patients up to week 16.
Literature
6.
go back to reference Wollenberg A, Kinberger M, Arents B, et al. European guideline (EuroGuiDerm) on atopic eczema - part II: non-systemic treatments and treatment recommendations for special AE patient populations [published online ahead of print, 2022 Sep 3]. J Eur Acad Dermatol Venereol. 2022. https://doi.org/10.1111/jdv.18429 Wollenberg A, Kinberger M, Arents B, et al. European guideline (EuroGuiDerm) on atopic eczema - part II: non-systemic treatments and treatment recommendations for special AE patient populations [published online ahead of print, 2022 Sep 3]. J Eur Acad Dermatol Venereol. 2022. https://​doi.​org/​10.​1111/​jdv.​18429
12.
go back to reference Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials [published correction appears in Lancet. 2021 Jun 5;397(10290):2150]. Lancet. 2021;397(10290):2151–2168. https://doi.org/10.1016/S0140-6736(21)00588-2. Guttman-Yassky E, Teixeira HD, Simpson EL, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials [published correction appears in Lancet. 2021 Jun 5;397(10290):2150]. Lancet. 2021;397(10290):2151–2168. https://​doi.​org/​10.​1016/​S0140-6736(21)00588-2.
13.
go back to reference Reich K, Teixeira HD, de Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial [published correction appears in Lancet. 2021 Jun 19;397(10292):2336] [published correction appears in Lancet. 2021 Aug 28;398(10302):746]. Lancet. 2021;397(10290):2169–2181. https://doi.org/10.1016/S0140-6736(21)00589-4. Reich K, Teixeira HD, de Bruin-Weller M, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial [published correction appears in Lancet. 2021 Jun 19;397(10292):2336] [published correction appears in Lancet. 2021 Aug 28;398(10302):746]. Lancet. 2021;397(10290):2169–2181. https://​doi.​org/​10.​1016/​S0140-6736(21)00589-4.
14.
go back to reference Blauvelt A, Teixeira HD, Simpson EL, et al. Efficacy and safety of upadacitinib vs dupilumab in adults with moderate-to-severe atopic dermatitis: a randomized clinical trial [published correction appears in JAMA Dermatol. 2022 Feb 1;158(2):219] [published correction appears in JAMA Dermatol. 2022 Feb 1;158(2):219]. JAMA Dermatol. 2021;157(9):1047–1055. https://doi.org/10.1001/jamadermatol.2021.3023. Blauvelt A, Teixeira HD, Simpson EL, et al. Efficacy and safety of upadacitinib vs dupilumab in adults with moderate-to-severe atopic dermatitis: a randomized clinical trial [published correction appears in JAMA Dermatol. 2022 Feb 1;158(2):219] [published correction appears in JAMA Dermatol. 2022 Feb 1;158(2):219]. JAMA Dermatol. 2021;157(9):1047–1055. https://​doi.​org/​10.​1001/​jamadermatol.​2021.​3023.
19.
Metadata
Title
Real-Life Effectiveness and Safety of Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A Single-Center 16-Week Study
Authors
Luigi Gargiulo
Luciano Ibba
Andrea Cortese
Jessica Avagliano
Mario Valenti
Antonio Costanzo
Alessandra Narcisi
Publication date
09-01-2023
Publisher
Springer Healthcare
Published in
Dermatology and Therapy / Issue 2/2023
Print ISSN: 2193-8210
Electronic ISSN: 2190-9172
DOI
https://doi.org/10.1007/s13555-022-00882-z

Other articles of this Issue 2/2023

Dermatology and Therapy 2/2023 Go to the issue