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.
HEADS UP was a Phase 3b, randomized, active-controlled, double-dummy trial of adult patients with moderate to severe AD. Patients were randomized 1:1 to RINVOQ 30 mg once daily + placebo subcutaneous every 2 weeks for dupilumab or dupilumab 300 mg subcutaneous every 2 weeks + placebo once daily for RINVOQ.4
*12-week follow-up. †Patients randomized to the dupilumab 300 mg SC Q2W group received the starting dose of 600 mg at the baseline visit.4
AD: atopic dermatitis; EASI: Eczema Activity and Severity Index; Q2W: every two weeks; QD: once daily; SC: subcutaneous; vIGA-AD 0/1: validated Investigator's Global Assessment for atopic dermatitis.
EFFICACY AND SAFETY DATA FROM THE HEAD TO HEAD STUDY "HEADS UP"
Watch Professor Kristian Reich, partner at Dermatologikum and founding member of SCIderm in Hamburg, Germany, discuss the key results from the HEADS UP trial.
EXPLORE THE 'HEADS UP' TRIAL
Download the HEADS UP journal reprint here.
[Article, journal]
Key inclusion criteria4
– 18 to 75 years with chronic ADa
– 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 TCIb within 6 months prior to BL
Key exclusion criteria4
– Topical treatments within 7 days prior to BLc
– Systemic therapy for AD or phototherapyd or traditional Chinese medicinee or any investigational drugf within 4 weeks prior to BL
– Prior exposure to dupilumab or systemic JAK inhibitors
aDiagnosis of AD according to the Hanifin and Rajka criteria (≥3 of 4 major features and ≥3 of 23 minor features); bor for patients for whom topical treatments were otherwise medically inadvisable; cexception of topical emollients; dlaser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments; eOral or parenteral; fwithin 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.
AE: adverse event; COVID-19: coronavirus disease 2019; EASI: Eczema Area and Severity Index; Q2W: every other week; QD: once daily.
AD: atopic dermatitis; BMI: body mass index; BSA: body surface area; EASI: Eczema Area and Severity Index; NRS: Numerical Rating Scale; 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.