Background: 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.Objective: We evaluated the efficacy and safety of upadacitinib + TCS through 52 weeks.Methods: 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 1 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 week 52. Missing data were primarily handled by nonresponse imputation incorporating multiple imputation for missing values due to coronavirus disease 2019 (COVID-19).Results: 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 15 mg + 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).Conclusions: 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.

Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results

Costanzo, Antonio;
2022-01-01

Abstract

Background: 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.Objective: We evaluated the efficacy and safety of upadacitinib + TCS through 52 weeks.Methods: 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 1 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 week 52. Missing data were primarily handled by nonresponse imputation incorporating multiple imputation for missing values due to coronavirus disease 2019 (COVID-19).Results: 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 15 mg + 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).Conclusions: 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.
2022
Atopic dermatitis
Janus kinase inhibitors
randomized clinical trial
topical corticosteroids
upadacitinib
Administration, Topical
Adolescent
Adrenal Cortex Hormones
Adult
Aged
Child
Dermatitis, Atopic
Dermatologic Agents
Double-Blind Method
Drug Therapy, Combination
Female
Heterocyclic Compounds, 3-Ring
Humans
Male
Middle Aged
Severity of Illness Index
Treatment Outcome
Young Adult
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11699/65263
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