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Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial.
- Source :
-
The Journal of allergy and clinical immunology [J Allergy Clin Immunol] 2020 Mar; Vol. 145 (3), pp. 877-884. Date of Electronic Publication: 2019 Nov 29. - Publication Year :
- 2020
-
Abstract
- Background: Atopic dermatitis is a chronic inflammatory skin disease characterized by pruritic skin lesions.<br />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.<br />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.<br />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).<br />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.<br /> (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Dose-Response Relationship, Drug
Double-Blind Method
Female
Heterocyclic Compounds, 3-Ring adverse effects
Heterocyclic Compounds, 3-Ring pharmacokinetics
Humans
Janus Kinase Inhibitors adverse effects
Janus Kinase Inhibitors pharmacokinetics
Male
Middle Aged
Dermatitis, Atopic drug therapy
Heterocyclic Compounds, 3-Ring administration & dosage
Janus Kinase Inhibitors administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6825
- Volume :
- 145
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- The Journal of allergy and clinical immunology
- Publication Type :
- Academic Journal
- Accession number :
- 31786154
- Full Text :
- https://doi.org/10.1016/j.jaci.2019.11.025