Purpose: This study aims to characterize the pharmacokinetics, safety, tolerability, and exploratory efficacy of upadacitinib, an oral Janus kinase inhibitor approved for treating moderate to severe atopic dermatitis (AD) in adults and adolescents, in children with severe AD.
Methods: In an open-label, multiple-dose, Phase 1 study, pediatric patients with severe AD from two age groups (2 to <6 years and 6 to <12 years) received bodyweight-based dosing regimens of upadacitinib using either twice-daily immediate-release (IR) oral solution or once-daily extended-release (ER) tablets. A pharmacokinetic assessment was conducted on Day 7 of the study, which was followed by a long-term safety and exploratory efficacy evaluation for up to 108 weeks.
J Clin Aesthet Dermatol
December 2022
Background: Isotretinoin, the gold standard treatment for nodulocystic acne vulgaris, is contraindicated in patients with a soy allergy. Due to potential cross-reactivity, a history of peanut allergy is listed as a contraindication to isotretinoin use in some countries.
Objective: We sought to further evaluate the safety of isotretinoin use in patients with peanut allergy.