A phase 3 randomized, multicenter, double-blind study to evaluate the safety of upadacitinib in combination with topical corticosteroids in adolescent and adult patients with moderate-to-severe atopic dermatitis in Japan (Rising Up): An interim 24-week analysis.

ABSTRACT:

Background

Systemic atopic dermatitis treatments that have acceptable safety are needed.

Objective

To evaluate the safety of the oral Janus kinase inhibitor upadacitinib in combination with topical corticosteroids (TCSs) for the treatment of atopic dermatitis.

Methods

In this phase 3, double-blind study (Rising Up), Japanese patients (12-75 years) with moderate-to-severe atopic dermatitis were randomized in a 1:1:1 ratio to receive 15 mg of upadacitinib + TCS, 30 mg of upadacitinib + TCS, or a placebo + TCS (rerandomized in a 1:1 ratio to receive either 15 or 30 mg of upadacitinib + TCS at week 16). Adverse events and laboratory data were assessed for safety.

Results

In 272 treated patients, the serious adverse event rates were similar for 15- and 30-mg upadaci

SUBMITTER: Katoh N 

PROVIDER: S-EPMC8693619 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature