RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy.1
Established safety profile in AD up to 6 years2
INTEGRATED SAFETY ANALYSIS | MEASURE UP 1 & 2 AND AD UP
Safety profile remained generally consistent over long-term exposures
†Excluding tuberculosis/herpes zoster. ‡Adjudicated. §n/100PY. ‖MACE was defined as CV death, nonfatal myocardinal infarction, and nonfatal stroke. ¶VTE was defined as deep vein thrombosis and pulmonary embolism.
RATES OF TEAEs OF SPECIAL INTEREST IN THE AD LONG-TERM SAFETY ANALYSIS2
Study design: The long-term safety up to 6 years of both doses of RINVOQ is based on the results of integrated data from 3 ongoing global pivotal Phase 3 studies in adults and adolescents ≥12 years of age with moderate to severe AD: MEASURE UP 1, MEASURE UP 2, and AD UP. Across the Phase 3 studies, patients were randomized 1:1:1 to receive RINVOQ 15 mg or 30 mg, or placebo QD as monotherapy (MEASURE UP 1 & 2) or in combination with TCS (AD UP). At Week 16, patients receiving RINVOQ 15 mg or 30 mg QD during the double-blinded period continued their assigned treatment in the blinded extension period, whereas patients receiving placebo were rerandomized to receive either RINVOQ 15 mg or 30 mg QD in the blinded extension period for up to 260 weeks.2
*Integrated safety analysis included 2683 patients (529 adolescents, 2154 adults) who received ≥1 dose of RINVOQ 15 mg or 30 mg.2
§§ELEVATE: AbbVie defines "ELEVATE" as the raising of the standards of care in AD patients, measured by WP-NRS and EASI score, treated with Dupilumab vs RINVOQ at week 16 of the head to head trials.4,5
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REFERENCES
- RINVOQ® (upadacitinib) Summary of Product Characteristics, available at www.medicines.ie.
- Bunick C, Silverberg SI, Chovatiya R, et al. Long-Term Upadacitinib Safety in Moderate to Severe Atopic Dermatitis up to 6 Years: An Integrated Analysis With Over 9000 Patient Years of Exposure. Presented at the 2024 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, December 8, 2024 [Ref DV# 013407].
- Guttman-Yassky E, Thyssen JP, Silverberg JI, et al. Safety of upadacitinib in moderate-to-severe atopic dermatitis: An integrated analysis of phase 3 studies. J Allergy Clin Immunol. 2023;151(1):172-181.
- Silverberg JI, Bunick CG, Hong HC, et al. Efficacy and safety of upadacitinib versus dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: week 16 results of an open-label randomized efficacy assessor-blinded head-to-head phase Illb/IV study (Level Up). Br J Dermatol. 2024;192(1):36-45.
- 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.
IE-RNQD-260014 Date of Preparation: May 2026
