The Phase 3 AD Up study findings through 52 weeks favored the potential of upadacitinib plus topical corticosteroids (TCS) as an effective, safe and well-tolerated long-term therapeutic choice with a positive benefit-risk profile in atopic dermatitis. This study aimed to determine the efficacy and safety of upadacitinib+TCS through 52 weeks in adults and adolescents (12-75 years) suffering from chronic atopic dermatitis.

Participants were randomly allocated to once-daily 15mg upadacitinib+TCS, 30mg upadacitinib+TCS, or placebo+TCS (re-randomized at week 16 to upadacitinib+TCS). Evaluation of the proportion of people attaining ≥75% improvement in Eczema Area and Severity Index (EASI-75), Worst Pruritis Numerical Rating Scale (WP-NRS) improvement ≥4, and validated Investigator’s Global Assessment for atopic dermatitis of clear or almost clear with ≥ 2 grades of improvement (vIGA-atopic dermatitis 0/1) was done through week 52.

Out of 901 patients, 300 were randomized to 15 mg upadacitinib+TCS, 297 to 30mg upadacitinib + TCS, and 304 to placebo + TCS. The efficacy of upadacitinib plus TCS at week 16 was found to be maintained through week 52 for all the outcomes. At week 52, the percentage of people attaining  EASI-75,  vIGA-atopic dermatitis 0/1, and  WP-NRS improvement ≥4 is shown in Table 1:

The combination of upadacitinib and TCS showed good tolerability over 52 weeks. No novel safety risks beyond the current label were noted. No deaths were noted; major adverse cardiovascular events and venous thromboembolic events were not frequent (≤0.2/100 patient-years). Thus, the findings depicted favorable safety and long-term maintenance of efficacy of upadacitinib plus TCS for the management of atopic dermatitis.