Acne Among Japanese Patients with Atopic Dermatitis Receiving Upadacitinib in the Phase 3 Rising Up Study

Introduction Upadacitinib, an oral selective Janus kinase (JAK) inhibitor, is used to treat moderate-to-severe atopic dermatitis (AD). Acne is the most common treatment-emergent adverse event in patients with AD treated with upadacitinib. In this post hoc analysis, we describe the acne events in Japanese patients with AD who received upadacitinib during the Rising Up study. Methods In this phase 3, double-blind, 3-year trial evaluating the safety and efficacy of upadacitinib 15 mg or 30 mg in Japanese patients with moderate-to-severe AD, patients were randomized 1:1:1 to receive upadacitinib 15 mg, 30 mg, or placebo for up to 16 weeks. At week 16, placebo-treated patients were re-randomized 1:1 to receive upadacitinib 15 mg or 30 mg. The incidence, characteristics, and management of treatment-emergent acne events up to the 52-week cutoff date were summarized. Results Among 272 patients in this analysis, the incidence of acne was higher in patients receiving upadacitinib compared with patients who received placebo. The rate of acne was higher in patients receiving upadacitinib 30 mg (32.4%) compared with those taking upadacitinib 15 mg (17.3%) during the long-term treatment period. All cases of acne were mild or moderate; no cases led to study drug discontinuation. The mean (range) of acne onset was 135.4 (7–465) days after starting study drug. Most acne occurred on the face; inflammatory papules were the most common morphology. Risk factors for acne included relevant concomitant medications (e.g., corticosteroids) started before acne onset and family and personal history of acne. Acne was generally managed with topical treatments. Conclusion Mild or moderate acne reported in Japanese patients with AD receiving upadacitinib occurred in a dose-dependent manner and had a variable onset time. Acne was readily managed with topical treatments. Patients and clinicians should be aware of the risk of acne associated with upadacitinib treatment for AD. Trial Registration ClinicalTrials.gov identifier, NCT03661138..

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:13

Enthalten in:

Dermatology and therapy - 13(2023), 8 vom: 25. Juni, Seite 1817-1830

Sprache:

Englisch

Beteiligte Personen:

Hayashi, Nobukazu [VerfasserIn]
Ikeda, Masanori [VerfasserIn]
Liu, John [VerfasserIn]
Raymundo, Eliza [VerfasserIn]
Liu, Yingyi [VerfasserIn]
Sasaki, Takuya [VerfasserIn]
Yamasaki, Kenshi [VerfasserIn]

Links:

Volltext [kostenfrei]

Themen:

Acne vulgaris
Atopic dermatitis
Eczema
Janus kinase inhibitors
Randomized controlled trial
Safety
Upadacitinib

Anmerkungen:

© The Author(s) 2023

doi:

10.1007/s13555-023-00961-9

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

OLC2144654158

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