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. 2023 Feb;13(2):651-660.
doi: 10.1007/s13555-022-00882-z. Epub 2023 Jan 9.

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

Luigi Gargiulo  1   2 , Luciano Ibba  3   4 , Andrea Cortese  1   2 , Jessica Avagliano  1 , Mario Valenti  1   2 , Antonio Costanzo  1   2 , Alessandra Narcisi  1
Affiliations

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

Luigi Gargiulo et al. Dermatol Ther (Heidelb). 2023 Feb.

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.

Keywords: Atopic dermatitis; Eczema; JAK inhibitors; Real-life; Therapy; Upadacitinib.

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Figures

Fig. 1
Fig. 1
Mean DLQI, itch-NRS, IGA, and EASI scores of our population at baseline, week 8 and week 16. DLQI Dermatology Life Quality Index, NRS Numerical Rating Scale, IGA Investigator Global Assessment, EASI Eczema Area and Severity Index
Fig. 2
Fig. 2
Percentages of patients achieving EASI 50, EASI 75, EASI 90, EASI 100, and absolute EASI ≤ 7 at weeks 8 and 16. EASI Eczema Area and Severity Index
See this image and copyright information in PMC

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