Watch as Dr James Del Rosso provides a detailed overview of the LEVEL UP trial, including study design, data review, and results 

AbbVie recently announced positive topline results from the LEVEL UP study, a head-to-head Phase 3b/4 clinical trial evaluating the efficacy and safety of upadacitinib (Rinvoq) versus dupilumab (Dupixent) in treating moderate-to-severe atopic dermatitis in adults and adolescents. In the study, upadacitinib demonstrated superior efficacy in achieving the primary endpoint, which was the simultaneous attainment of near-complete skin clearance (EASI 90) and minimal to no itch (WP-NRS 0/1) at Week 16. Specifically, 19.9% of patients treated with upadacitinib met this endpoint, vs 8.9% of those treated with dupilumab (p<0.0001). 

Study overview: LEVEL UP Phase 3b/4 trial 

The LEVEL UP study was an open-label, efficacy assessor-blinded study that enrolled patients aged 12 years and older with moderate-to-severe atopic dermatitis who had an inadequate response to systemic therapy or for whom systemic therapy was inadvisable. The trial is the first head-to-head trial in atopic dermatitis to compare upadacitinib at a starting dose of 15 mg daily to dupilumab administered at its labeled dose. 

Secondary endpoints 

Upadacitinib also demonstrated superiority vs dupilumab across all ranked secondary endpoints. Notably, 40.8% of patients treated with upadacitinib achieved EASI 90 at Week 16, compared to 22.5% of those treated with dupilumab (p<0.0001). Furthermore, 30.2% of upadacitinib-treated patients reached a WP-NRS of 0/1 at Week 16, compared to 15.5% of dupilumab-treated patients (p<0.0001). 

Consistent safety profile 

The safety profile of upadacitinib observed in the LEVEL UP study was consistent with previous studies in upadacitinib for atopic dermatitis, with no new safety signals identified during the 16-week trial period. The most common adverse event reported for both upadacitinib and dupilumab groups was nasopharyngitis. The rate of serious adverse events (0.9%) was the same for both treatment groups, and no malignancies, major adverse cardiac events, venous thromboembolic events, or treatment-emergent deaths were reported in either group.