Upadacitinib Bests Dupilumab in Head-to-Head Atopic Dermatitis Study

Among patients with moderate to severe atopic dermatitis, upadacitinib was found to be superior to dupilumab for skin clearance and itch resolution, according to results from a head-to-head phase 3b/4 study.

The randomized, open-label, efficacy assessor-blinded LEVEL UP study (ClinicalTrials.gov Identifier: NCT05601882) included patients 12 years of age and older weighing at least 40kg with moderate to severe atopic dermatitis who had an inadequate response to systemic therapy or when use of those therapies was inadvisable. 

Study participants were randomly assigned to receive either upadacitinib once daily (dose-adjusted based on clinical response) or dupilumab (as per its labeled dose) for 16 weeks.

Findings showed a significantly higher proportion of patients treated with upadacitinib achieved both 90% or greater reduction in Eczema Area and Severity Index (EASI 90) and a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) compared with those who received dupilumab (primary endpoint; 19.9% vs 8.9%, respectively; P <.0001).

When assessing each outcome individually, a higher percentage of patients in the upadacitinib group achieved EASI 90 (40.8% vs 22.5%; P <.0001) and WP-NRS of 0/1 (30.2% vs 15.5%; P <.0001) vs the dupilumab group.

No new safety signals were observed in the trial. The most common adverse event reported in both groups was nasopharyngitis.

Detailed study results will be presented at a future medical congress.

Upadacitinib, a Janus kinase (JAK) inhibitor, is currently marketed under the brand name Rinvoq for patients aged 12 years and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when those therapies are inadvisable.

Dupilumab, an interleukin-4 receptor alpha antagonist, is available under the brand name Dupixent for adult and pediatric patients 6 months of age and older with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.