• Robust EASI 75 & 90 skin clearance rates at Week 16, sustained through Week 521-4
• Rapid skin clearance with EASI 75 as early as Week 21,2
• Significant itch reduction rates (NRS ≥4)* at Week 16, sustained through Week 521-4
• Rapid itch reduction (NRS ≥4)* 1 day after treatment initiation with RINVOQ 30 mg†‡§1,2
• Well-studied safety profile with 6 indications, 7 years of clinical trial experience beginning in RA, and >138,000 patients treated with RINVOQ worldwide.
• The first and only oral JAK inhibitor approved for adolescents ≥12 years with moderate to severe AD¥8,9
• Similar safety profile with RINVOQ 15 mg across adults and adolescents in AD‖1
*With a ≥4-point improvement in Worst Pruritus NRS from baseline.1,2
**With 30 mg dose only; 2 days after initiation with 15 mg dose.1,2
†Mean percent change in Worst Pruritus NRS from baseline.1,2
‡RINVOQ 30 mg QD vs dupilumab 300 mg Q2W.4
§Use in adolescents is approved for 15 mg dosage option only. The safety and efficacy of RINVOQ in children with atopic dermatitis below the age of 12 years have not been established. No data are available. No clinical exposure data are available in adolescents <40 kg. The posology in adolescent patients 30 kg to <40 kg was determined using population pharmacokinetic modeling and simulation.1
‖RINVOQ 30 mg is still being investigated for adolescents. Only RINVOQ 15 mg is currently approved for use in adolescents.1
AD: Atopic Dermatitis; EASI: Eczema Area and Severity Index; EASI 75/90: ≥75/90% reduction in EASI; JAK: janus kinase; NRS: numerical rating scale; Q2W: once every two weeks; QD: once daily; TCS: topical corticosteroids.
RINVOQ preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. Atopic dermatitis (AD) is driven by pro-inflammatory cytokines that transduce signals via the JAK1 pathway. Inhibiting JAK1 with RINVOQ reduces the signaling of many mediators which drive the signs and symptoms of AD.1
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.
AD: atopic dermatitis; AS: ankylosing spondylitis; PsA: psoriatic arthritis; RA: rheumatoid arthritis.
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.
- Simpson E, Papp K, Blauvelt A, et al. Efficacy and Safety of Upadacitinib in Patients With Atopic Dermatitis: Results Through Week 52 From Replicate, Phase 3, Randomized, Double-Blind, Placebo-Controlled Studies: Measure Up 1 and Measure Up 2. Poster at the 2021 Dermatology Education Foundation (DEF) Essential Resource Meeting (DERM2021), August 5–8, 2021, Las Vegas NV, USA.
- Simpson EL, Papp KA, Blauvelt A, et al. Efficacy and safety of upadacitinib in patients with moderate to severe atopic dermatitis: analysis of follow-up data from the Measure Up 1 and Measure Up 2 randomized clinical trials. JAMA Dermatol. 2022;158(4):404–413.
- 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.
- European Medicines Agency. RINVOQ EPAR: Public Assessment Report. Available at: https://www.ema.europa.eu/en /medicines/human/EPAR/rinvoq. Accessed April 2021.
- 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.
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- Kameda H, Takeuchi T, Yamaoka K, et al. Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo-controlled phase IIb/III study. Rheumatology (Oxford). 2020;59(11): 3303–3313.
- Xiaofeng Zeng, Dongbao Zhao, Sebastiao Radominski, Efficacy and Safety of Upadacitinib in Patients From China, Brazil, and South Korea With Rheumatoid Arthritis Who Have Had Inadequate Response to Conventional Synthetic Disease-Modifying Antirheumatic Drugs. Abstract presented at the European Congress of Rheumatology, 3–6 June 2020. Abstract SAT0160.
- ClinicalTrials.gov A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (Rising Up). Available at: https://clinicaltrials.gov/ct2/show/ NCT03661138. Accessed March 2021.
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