Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials.

ABSTRACT:

Background

Baricitinib, a selective Janus kinase 1/Janus kinase 2 inhibitor, is indicated in the European Union and Japan for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.

Objective

The objective of this study was to evaluate the safety of baricitinib 2 mg in the AD clinical program.

Methods

Six double-blind, randomized, placebo-controlled studies, and two long-term extension studies were summarized in two datasets. Placebo comparison was based on six 16-week studies with baricitinib 2 mg. All-bari-2-mg-AD included patients who received baricitinib 2 mg at any time during the eight studies.

Results

In total, 1598 patients received once-daily baricitinib 2 mg for 1434.2 patient-years of exposure (me

SUBMITTER: King B 

PROVIDER: S-EPMC8068648 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature