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Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial

Open access
Guttman-Yassky, Emma, Thaçi, Diamant, Pangan, Aileen L., Hong, H. Chih-ho, Papp, Kim A., Reich, Kristian, Beck, Lisa A., Mohamed, Mohamed-Eslam F., Othman, Ahmed A., Anderson, Jaclyn K., Gu, Yihua, Teixeira, Henrique D., Silverberg, Jonathan I.·2020·Journal of Allergy and Clinical Immunology

Abstract

BACKGROUND: Atopic dermatitis is a chronic inflammatory skin disease characterized by pruritic skin lesions. OBJECTIVE: We sought to evaluate the safety and efficacy of multiple doses of the selective Janus kinase 1 inhibitor upadacitinib in patients with moderate to severe atopic dermatitis. METHODS: In the 16-week, double-blind, placebo-controlled, parallel-group, dose-ranging portion of this 88-week trial in 8 countries (ClinicalTrials.gov, NCT02925117; ongoing, not recruiting), adults with moderate to severe disease and inadequate control by topical treatment were randomized 1:1:1:1, using an interactive response system and stratified geographically, to once-daily upadacitinib oral monotherapy 7.5, 15, or 30 mg or placebo. The primary end point was percentage improvement in Eczema Area and Severity Index from baseline at week 16. Efficacy was analyzed by intention-to-treat in all randomized patients. Safety was analyzed in all randomized patients who received study medication, based on actual treatment. RESULTS: Patients (N = 167) enrolled from November 21, 2016, to April 20, 2017. All were randomized and analyzed for efficacy (each upadacitinib group, n = 42; placebo, n = 41); 166 were analyzed for safety (each upadacitinib group, n = 42; placebo, n = 40). The mean (SE) primary efficacy end point was 39% (6.2%), 62% (6.1%), and 74% (6.1%) for the upadacitinib 7.5-, 15-, and 30-mg groups, respectively, versus 23% (6.4%) for placebo (P = .03, <.001, and <.001). Serious adverse events occurred in 4.8% (2 of 42), 2.4% (1 of 42), and 0% (0 of 42) of upadacitinib groups (vs 2.5% [1 of 40] for placebo). CONCLUSIONS: A dose-response relationship was observed for upadacitinib efficacy; the 30-mg once-daily dose showed the greatest clinical benefit. Dose-limiting toxicity was not observed.

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Metadata

Authors
Guttman-Yassky, E., Thaçi, D., Pangan, A. L., Hong, H. C.-H., Papp, K. A., Reich, K., Beck, L. A., Mohamed, M.-E. F., Othman, A. A., Anderson, J. K., Gu, Y., Teixeira, H. D., & Silverberg, J. I.
Venue
Journal of Allergy and Clinical Immunology
Publisher
Elsevier BV
Published
2020-03
Volume
145
Issue
3
Pages
877-884
ISSN
0091-6749 (ISSN-L)
OpenAlex
W2991540591
Cited by
369
References
28
FWCI
37.87
Type
journal article
Language
en
Open access
hybrid

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CoChat. (2026). Citation check: Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial. https://app.cochat.ai/papers/10.1016/j.jaci.2019.11.025
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Guttman-Yassky, E., Thaçi, D., Pangan, A. L., Hong, H. C.-H., Papp, K. A., Reich, K., Beck, L. A., Mohamed, M.-E. F., Othman, A. A., Anderson, J. K., Gu, Y., Teixeira, H. D., & Silverberg, J. I. (2020). Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial. Journal of Allergy and Clinical Immunology. https://doi.org/10.1016/j.jaci.2019.11.025

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.