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
See study designs, hear from experts, and download publications below.
The MEASURE UP 1 & 2 clinical studies were two Phase 3, randomized, placebo-controlled studies 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 monotherapy, or placebo.2
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).2
*TCS were permitted during the blinded extension period and were not counted as rescue therapy.2 †30-day follow up.
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; TCS: topical corticosteroid; vIGA-AD 0/1: validated Investigator's Global Assessment for atopic dermatitis 0 or 1 response.
‘MEASURE UP' KEY RESULTS:
EXPERT PERSPECTIVE
Watch Professor Alan Irvine from Trinity College School of Medicine in Dublin, Ireland, summarize the MEASURE UP 1 & 2 study designs and key results.
EXPLORE THE 'MEASURE UP' TRIALS
Download the MEASURE UP 1 & 2 journal reprint here.
[Article, journal]
Key inclusion criteria2
– 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 criteria2
– Topical treatments within 7 days prior to BLd
– Systemic therapy for AD or phototherapye 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.
aNo patients were discontinued for COVID-19 infection or logistical restrictions.
bIncludes protocol-mandated discontinuation because of 25% worsening of EASI and other reasons.
AE: adverse event; COVID-19: coronavirus disease 2019; EASI: Eczema Area and Severity Index.
Based on ITT Population. Calculations are based on non-missing records.
aBased on weekly average.
AD: atopic dermatitis; BMI: body mass index; BSA: body surface area; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; ITT: intent-to-treat for the main study; NRS: Numerical Rating Scale; POEM: Patient-oriented Eczema Measure; vIGA-AD: validated Investigator’s Global Assessment for AD.
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.