Efficacy and safety of upadacitinib vs dupliumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (Level Up)

Document Type

Conference Proceeding

Publication Date

8-8-2024

Publication Title

Br J Dermatol

Abstract

Introduction/Background Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by intense itch and eczematous skin lesions. Some patients with AD continue to experience flares and substantial clinical burden despite the use of systemic therapy. Upadacitinib is a selective oral Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 versus JAK2, JAK3, and tyrosine kinase 2. Dupilumab is a monoclonal antibody inhibiting interleukin-4 and interleukin-13 signaling. Both upadacitinib and dupilumab are approved in multiple countries for the treatment of moderate-to-severe AD in adolescents and adults. Objectives This monotherapy study assessed the efficacy and safety of upadacitinib, initiated at 15 mg once daily (QD) and dose-escalated to 30 mg QD based on clinical response, compared with dupilumab per its label. Results presented here are based on the Week 16 primary analysis. Methods Level Up is a phase 3b/4 global, randomized, open-label, efficacy assessor blinded, head-to-head, multi-center study evaluating upadacitinib vs dupilumab in adolescents and adults with moderate-to-severe AD who had inadequate response to systemic therapy or when use of those therapies was inadvisable. Patients were randomized to upadacitinib 15 mg or dupilumab per its label for 16 weeks of treatment (Period 1), with an extension period to 32 weeks (Period 2) for patients not achieving at least 75% reduction in Eczema Area and Severity Index from baseline (EASI 75) at Week 16. Patients on upadacitinib 15 mg were dose-escalated to 30 mg starting from Week 4 if they had a

Volume

191

First Page

ii112

Last Page

ii113

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