Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results.
J Allergy Clin Immunol
; 149(3): 977-987.e14, 2022 03.
Article
in English
| MEDLINE | ID: covidwho-1356276
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 111 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 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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Adrenal Cortex Hormones
/
Dermatitis, Atopic
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Dermatologic Agents
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Heterocyclic Compounds, 3-Ring
Type of study:
Experimental Studies
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Prognostic study
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Randomized controlled trials
Limits:
Adolescent
/
Adult
/
Aged
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Child
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Female
/
Humans
/
Male
/
Middle aged
/
Young adult
Language:
English
Journal:
J Allergy Clin Immunol
Year:
2022
Document Type:
Article
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