For your moderate to severe Atopic Dermatitis patients ≥12 years1
†Itch reduction responders at Day 3 with RINVOQ 15 mg. Data from MEASURE UP 1 and 2: replicate, phase 3 randomised, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib monotherapy vs placebo in adolescents and adults with moderate-to-severe AD. Upadacitinib 15 mg n=281 and 276; 30 mg n=285 and 282; placebo n=281 and 278. Co-primary endpoints were EASI 75 and vIGA-AD of 0 or 1 with ≥2 grades of reduction at Week 16 (NRI-C). Co-primary and all secondary endpoints were met (p≤0.001 for all vs placebo).
§Superior EASI 75 vs dupilumab at Week 16 (p=0.006), multiplicity controlled. Data from HEADS UP: a phase 3 randomised, double blind, double-dummy, active-controlled study comparing the safety and efficacy of upadacitinib 30 mg OD to dupilumab 300 mg Q2W in adults with moderate-to-severe AD. Upadacitinib 30 mg n=348; dupilumab 300 mg n=344. Primary endpoint was EASI 75 at Week 16. Primary endpoint and all secondary endpoints were met (p=0.006 and p<0.001 respectively vs dupilumab).
*Superiority was demonstrated in the HEADS UP trial using the RINVOQ 30 mg dose in adults aged 18 – 75 years. The 30 mg dose is licensed for use in adults aged 18 – 64 years. For patients aged 65 years or older the recommended dose is 15 mg once daily.
AD, atopic dermatitis; EASI, Eczema Area and Severity Index; EASI 75, ≥75% reduction in EASI; OD, once daily; Q2W, once every two weeks; RIN, RINVOQ; vIGA-AD 0/1, Validated Investigator’s Global Assessment for AD of clear or almost clear.
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
Atopic dermatitis
RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
AD, atopic dermatitis; AS, ankylosing spondylitis; PsA, psoriatic arthritis; RA, rheumatoid arthritis.
- RINVOQ Summary of Product Characteristics.
- Guttman-Yassky E, Teixeira HD, Simpson EL, 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.
- Blauvelt A, Teixeira H, Simpson E, et al. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis. A Randomized Clinical Trial. JAMA Dermatol. 2021; Published online August 4, 2021. DOI:10.1001/jamadermatol.2021.3023.
UK-RNQD-210278. Date of preparation: March 2022
Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.
Adverse events should also be reported to AbbVie on GBPV@abbvie.com