RINVOQ® is an oral selective and reversible JAK inhibitor indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.1
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AD UP was a Phase 3, randomized, placebo-controlled, double-blind study of adult and adolescent (≥12 years of age) patients with moderate to severe AD. Patients were randomized 1:1:1 to RINVOQ 15 mg or 30 mg once daily + topical corticosteroids (TCS), or placebo once daily + TCS.3
Efficacy analysis conducted in the ITT population of the double-blind treatment period and missing data for the co-primary and ranked secondary endpoints were handled using NRI-C (non-responder imputation incorporating MI to handle missing data due to COVID-19).3
*TCI permitted for use in areas where TCS is generally not advisable;3 †30-day follow up.3
AD: atopic dermatitis; BID: twice daily; BL: baseline; COVID-19: coronavirus disease 2019; EASI: Eczema Activity and Severity Index; ITT: intention-to-treat population; MI: multiple imputation; QD: once daily; TCI: topical calcineurin inhibitor; TCS: topical corticosteroid; vIGA-AD 0/1: validated Investigator's Global Assessment for atopic dermatitis 0 or 1 response.
TAKE A CLOSER LOOK AT THE 'AD UP' TRIAL
Download the AD UP journal reprint here.
[Article, journal]
Key inclusion criteria3
– 12 to 75 yearsa with chronic ADb
– AD symptoms ≥3 years
– ≥10% BSA, EASI ≥16, and IGA ≥3
– BL weekly average of daily Worst Pruritus NRS ≥4
– Inadequate response to TCS or TCIc within 6 months prior to BL
Key exclusion criteria3
– Topical treatments within 7 days prior to BLd
– Systemic therapy for AD or phototheraphye or traditional Chinese medicinef or any investigational drugg within 4 weeks prior to BL
– Prior exposure to dupilumab or systemic JAK inhibitors
aBody weight ≥40 kg at BL for subjects ≥12 and <18 yrs; bDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features); cor for patients for whom topical treatments were otherwise medically inadvisable; dexception of topical emollients; elaser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments; fOral or parenteral; gwithin 4 weeks or five half-lives of the drug (whichever is longer) or is currently enrolled in another clinical study.
AD: atopic dermatitis; BL: baseline; BSA: body surface area; EASI: eczema activity and severity index; IGA: investigator’s global assessment; JAK: Janus kinase; NRS: Numerical Rating Scale; TCI: topical calcineurin inhibitor; TCS: topical corticosteroids.
AD UP TOPICAL CORTICOSTEROID REGIMEN THROUGH WEEK 523
TCI should be applied QD on areas of thin skin or on areas where medium TCS are considered unsafe (e.g., areas of skin atrophy).
QD: once daily; TCI: topical calcineurin inhibitor; TCS: topical corticosteroids.
AE: adverse event; COVID-19: coronavirus disease 2019; ITT: intention to treat for the main study; TCS: topical corticosteroids.
Based on ITT Population.
aBased on weekly average. bPatients aged ≥16 years.
BMI: body mass index; BSA: body surface area; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; ITT: intention to treat for the main study; NRS: Numerical Rating Scale; POEM: Patient-oriented Eczema Measure; TCS: topical corticosteroids; vIGA-AD: validated Investigator’s Global Assessment for Atopic Dermatitis.
FIND OUT MORE ABOUT RINVOQ
REFERENCES
- RINVOQ® (upadacitinib) Summary of Product Characteristics. AbbVie Deutschland GmbH & Co. KG: June 2022.
- Guttman-Yassky E, Teixeira H, Simpson E, et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021; 397(10290): 2151–2168.
- Reich K, Teixeira HD, Bruin-Weller, et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021; 397(10290): 2169–2181.
- Blauvelt A, Teixeira HD, Simpson EL, et al. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021;157(9):1047–1055.