Abstract
Primary (week 16) results from the ongoing phase 3, double-blind AD Up study (NCT03568318) demonstrate a positive benefit-risk profile for upadacitinib + topical corticosteroid (TCS) in patients with moderate-to-severe atopic dermatitis. We evaluated the efficacy and safety of upadacitinib+ TCS through 52 weeks. Patients aged 12 to 75 years with chronic moderate-to-severe atopic dermatitis (≥10% of body surface area affected, Eczema Area and Severity Index [EASI] ≥16, Validated Investigator's Global Assessment for atopic dermatitis [vIGA-AD] ≥3, and Worst Pruritus Numerical Rating Scale [WP-NRS] score ≥4) were randomized 1:1:1 to once-daily upadacitinib 15 mg +TCS, upadacitinib 30 mg+ TCS, or placebo (PBO)+ TCS (rerandomized at week 16 to upadacitinib+ TCS). Safety and efficacy, including proportion of patients experiencing ≥75% improvement in EASI (EASI-75), vIGA-AD of clear/almost clear with improvement ≥2 grades (vIGA-AD 0/1), and WP-NRS improvement ≥4, were assessed through week52. Missing data were primarily handled by nonresponse imputation incorporating multiple imputation for missing values due to coronavirus disease 2019 (COVID-19). Of 901 patients, 300 were randomized to upadacitinib 15 mg+ TCS, 297 to upadacitinib 30 mg+ TCS, and 304 to PBO+ TCS. For all end points, efficacy for upadacitinib 15mg+ TCS and upadacitinib 30 mg+ TCS at week 16 was maintained through week 52. At week 52, the proportions of patients treated with upadacitinib 15 mg+ TCS and upadacitinib 30 mg+ TCS who experienced EASI-75 were 50.8% and 69.0%, respectively; 33.5% and 45.2%, respectively, experienced vIGA-AD 0/1; and 45.3% and 57.5%, respectively, experienced WP-NRS improvement ≥4. Upadacitinib+ TCS was well tolerated through 52 weeks; no new important safety risks beyond the current label were observed. No deaths were reported; major adverse cardiovascular events and venous thromboembolic events were infrequent (≤0.2/100 patient-years). Results through 52 weeks demonstrate long-term maintenance of efficacy and a favorable safety profile of upadacitinib+ TCS in patients with moderate-to-severe AD.
Highlights
Primary results from the ongoing phase3, double-blind Atopic dermatitis (AD) Up study (NCT03568318) demonstrate a positive benefit–risk profile for upadacitinib 1 topical corticosteroid (TCS) in patients with moderate-to-severe atopic dermatitis
There is a need for additional AD treatments that are acceptable for long-term use and that provide prolonged clinical response without high levels of treatment discontinuation due to adverse effects.[12,13]
Systemic therapies are often used in combination with topical corticosteroids (TCS) to control moderate-to-severe AD symptoms.[14]
Summary
From weeks 4 to 24, if a patient did not experience EASI-50 at any 2 consecutive scheduled study visits, rescue therapy with high- or superhighpotency TCS (unless higher-potency TCS was considered unsafe) or other topical AD medications (eg, topical calcineurin inhibitor or crisaborole) was allowed as needed, escalating to systemic rescue medication only for disease that did not respond adequately after 7 days of topical treatment. From weeks to 52, rescue therapy was allowed as needed if EASI-50 was not recorded at any scheduled visit. Patients who received any rescue therapy were considered to have nonresponsive disease for subsequent visits; patients who received rescue therapy with topical AD treatments or oral corticosteroids for
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