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New post-hoc analysis demonstrated efficacy of RINVOQ® (upadacitinib) in moderate-to-severe atopic dermatitis patients with varying degrees of severity in head and neck involvement, with results in skin clearance, itch resolution and impact on quality of life at 16 weeks1
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Atopic dermatitis in the head and neck regions can have a significant impact on the quality of life for patients and is highly prevalent based on real-world observational studies2-4
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New data showcasing depth and strength across AbbVie's dermatology portfolio will be presented at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam
NORTH CHICAGO, Ill., Sept. 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from a new post-hoc analysis from the Measure Up 1 and Measure Up 2 Phase 3 studies. The analysis evaluated the efficacy of upadacitinib (15 mg or 30 mg) in patients with moderate-to-severe atopic dermatitis (AD) stratified by the severity of disease in the head and neck region at baseline compared to placebo across 16 weeks.1
In this analysis, several optimal and stringent treatment targets – including the achievement of near complete skin clearance in the head and neck region (EASI Head & Neck score <1), near complete skin clearance (EASI 90), no to little itch (WP-NRS 0/1) and minimal or no impact on quality of life (DLQI 0/1) – were assessed with the treatment of upadacitinib across patient subgroups. Patients were stratified by no-to-mild, moderate, or severe head and neck involvement.1
Living with uncontrolled AD can have a substantial physical, emotional and social impact on patients' lives and is often associated with significant long-term disease burden from debilitating symptoms.5 Research shows that AD in specific sites such as the head, neck, face and hands can have a significant impact on symptom frequency and quality of life for patients.2,6 In the real-world observational setting, 70% of AD patients in the UP-TAINED study and at least 74.5% of AD patients in the AD-VISE study had head and neck region involvement at baseline.3,4 The high prevalence reinforces the need for effective therapies in this high impact, challenging to treat area.
"These data stratify the severity of atopic dermatitis in the head and neck region, which is a part of the body that has significant impact on patients and is challenging to treat," said Kilian Eyerich, MD, PhD, chair and professor at the Department of Dermatology and Venerology of the University of Freiburg, Germany. "At 16 weeks, RINVOQ showed efficacy in patients with moderate-to-severe atopic dermatitis with various degrees of head and neck involvement, achieving optimal treatment targets with combined measures of EASI 90 and WP-NRS 0/1, along with improvement on the patients' quality of life measured by DLQI 0/1 in a substantial number of patients."
New post-hoc analysis of the Measure Up 1 and Measure Up 2 studies showed that a higher proportion of patients with moderate-to-severe AD with varying degrees of head and neck involvement treated with upadacitinib (15 mg or 30 mg) achieved the following optimal treatment targets compared to placebo at week 16: near complete skin clearance in the head and neck region (EASI Head & Neck Score <1), minimal or no impact on quality of life (DLQI 0/1), and minimal disease activity, which is the simultaneous achievement of near complete skin clearance (EASI 90) and no to little itch (WP-NRS 0/1)1:
P0734 E-poster
Primary efficacy and safety results from these ongoing pivotal studies have been previously reported: https://rb.gy/oqscek.
"Despite taking steps to manage their condition, many patients with atopic dermatitis continue to live with debilitating symptoms, especially in highly visible areas such as head and neck that can intensify one's physical and emotional burden," said Andrew Anisfeld, PhD, vice president, global medical affairs, immunology, AbbVie. "These data contribute to our ongoing commitment to elevate the standard of care in atopic dermatitis so patients can strive for the best possible outcomes."
Additional abstracts to be presented at EADV 2024 supporting the efficacy and safety profile of RINVOQ (upadacitinib) for moderate-to-severe AD include:
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Efficacy and safety of upadacitinib vs dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (LEVEL UP): This study evaluated the efficacy and safety of RINVOQ (15 mg once daily starting dose and dose-adjusted based on clinical response) versus dupilumab (per its labeled dose) in adults and adolescents (≥12 years of age) with moderate-to-severe atopic dermatitis (AD) who had an inadequate response to systemic therapy or when use of those therapies was inadvisable. The primary endpoint was achievement of both EASI 90 and WP-NRS 0/1 at Week 16.7
FC08.04 Oral Presentation on Friday, 27 September 2024, 16:30-16:40
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Effectiveness of upadacitinib in adults and adolescents with atopic dermatitis: 6-month interim analysis of the real-world multicountry AD-VISE study: An interim analysis of the AD-VISE study evaluating the effectiveness and durability of response to upadacitinib for skin clearance (EASI) and itch resolution (WP-NRS) in real-world settings. Results include 578 adult and adolescent patients with moderate-to-severe AD treated with upadacitinib (15 mg or 30 mg).3
P0683 E-Poster
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Baseline criteria from a real world non-interventional study with Upadacitinib for the treatment of systemic atopic dermatitis: an analysis based on guideline criteria (UP-TAINED): An interim analysis of the UP-TAINED study including baseline visit data from 351 patients with moderate-to-severe AD treated with upadacitinib in real-world settings in Germany. Results show that patients treated with upadacitinib met German checklist criteria for systemic therapy.4
P0535 E-Poster
About Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin.8,9 It affects up to an estimated 10% of adults and 24.6% of adolescents.9-11 Between 20% and 46% of adults with atopic dermatitis have moderate-to-severe disease.12 The range of symptoms poses significant physical, psychological and economic burden on individuals impacted by the disease.9,13
About Measure Up 1 and Measure Up 2
Measure Up 1 and Measure Up 2 are Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled studies designed to evaluate the safety and efficacy of RINVOQ in adult and adolescent (12 years or older) patients with moderate to severe atopic dermatitis who are candidates for systemic treatment. Patients were randomized to RINVOQ 15 mg, RINVOQ 30 mg or placebo. The co-primary endpoints were the percentage of patients achieving EASI 75 and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 after 16 weeks of treatment. Patients receiving placebo were switched to either RINVOQ 15 mg or RINVOQ 30 mg at week 16.14,15
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.16
Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.17-22
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
References:
1.Eyerich K, Mendes-Bastos P, Holzer G, et al. Efficacy of upadacitinib in treating atopic dermatitis in the head and neck regions. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0734.
2.Silverberg JI, et al. Patient burden and quality of life in atopic dermatitis in US adults: a population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340-C347. doi:10.1016/j.anai.2018.07.006
3.Gooderham MJ, Pereyra-Rodriguez JJ, Sinclair R, et al. Effectiveness of upadacitinib in adults and adolescents with atopic dermatitis: 6-month interim analysis of the real-world multicountry AD-VISE study. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0683.
4.Weidinger S, Pinter A, Weyergraf T, et al. Baseline criteria from a real world non-interventional study with upadacitinib for the treatment of systemic atopic dermatitis: an analysis based on guideline criteria. Poster presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. ePoster P0535.
5.Wollenberg A, Gooderham M, Katoh N, et al. Patient-reported burden in adults with atopic dermatitis: an international qualitative study. Arch Dermatol Res. 2024;316(7):380. doi:10.1007/s00403-024-03130-w
6.Hang L, Aroman MS, Taieb C, et al. The impact of eczema involving visible areas of the skin on patients' quality of life. JEADV Clin Pract. 2022;1:105-110. doi:10.1002/jvc2.20
7.Silverberg JI, Bunick C, Hong HC, et al. Efficacy and safety of upadacitinib vs dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (Level Up). Paper presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, the Netherlands. FC08.04.
8.Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16. doi:10.1159/000370220
9.Weidinger S, Beck LA, Bieber T, Kabashima K, Irvine A. Atopic dermatitis. Nat Rev Dis Primers. 2018;4(1):1. doi:10.1038/s41572-018-0001-z
10.Simpson EL, Paller AS, Siegfried EC, et al. Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis: a phase 3 randomized clinical trial. JAMA Dermatol. 2020;156(1):44-56. doi:10.1001/jamadermatol.2019.3336
11.Blauvelt A, Guttman-Yassky E, Paller AS, et al. Long-term efficacy and safety of dupilumab in adolescents with moderate-to-severe atopic dermatitis: results through week 52 from a phase III open-label extension trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022;23(3):365-383. doi:10.1007/s40257-022-00683-2
12.Shrestha S, Miao R, Wang L, Chao J, Yuce H, Wei W. Burden of atopic dermatitis in the United States: analysis of healthcare claims data in the commercial, Medicare, and Medi-Cal databases. Adv Ther. 2017;34(8):1989-2006. doi:10.1007/s12325-017-0582-z
13.European Federation of Allergy and Airways Diseases Patients' Associations. Atopic eczema: itching for life report—quality of life and costs for people with severe atopic eczema in Europe. Published July 2018. Accessed August 28, 2023. https://www.efanet.org/images/2018/EN_-_Itching_for_life_Quality_of_Life_and_costs_for_people_with_severe_atopic_eczema_in_Europe_.pdf
14.Evaluation of upadacitinib in adolescent and adult patients with moderate to severe atopic dermatitis (eczema) (Measure Up 1). ClinicalTrials.gov identifier: NCT03569293. Updated March 5, 2024. Accessed April 9, 2024. https://clinicaltrials.gov/study/NCT03569293
15.A study to evaluate upadacitinib in adolescents and adults with moderate to severe atopic dermatitis (Measure Up 2). ClinicalTrials.gov identifier: NCT03607422. Updated March 5, 2024. Accessed April 9, 2024. https://clinicaltrials.gov/study/NCT03607422
16.RINVOQ. Summary of product characteristics. AbbVie. Accessed September 19, 2024.
17.A study to evaluate the safety and effectiveness of upadacitinib tablets in adult and adolescent participants with severe alopecia areata (Up-AA). ClinicalTrials.gov identifier: NCT06012240. Updated September 19, 2024. Accessed September 19, 2024. https://clinicaltrials.gov/study/NCT06012240
18.A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov identifier: NCT03725202. Updated February 23, 2024. Accessed September 19, 2024. https://clinicaltrials.gov/ct2/show/NCT03725202
19.A study to assess change in disease activity and adverse events of oral upadacitinib in adult and adolescent participants with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy (Step-Up HS). ClinicalTrials.gov identifier: NCT05889182. Updated August 29, 2024. Accessed April 9, 2024. https://clinicaltrials.gov/study/NCT05889182
20.A study to evaluate the efficacy and safety of upadacitinib in participants with Takayasu arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov identifier: NCT04161898. Updated March 22, 2024. Accessed April 9, 2024. https://clinicaltrials.gov/study/NCT04161898
21.Program to assess adverse events and change in disease activity of oral upadacitinib in adult participants with moderate to severe systemic lupus erythematosus (SELECT-SLE). ClinicalTrials.gov identifier: NCT05843643. Updated September 19, 2024. Accessed April 9, 2024. https://clinicaltrials.gov/study/NCT05843643
22.A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo (Viti-Up). ClinicalTrials.gov identifier: NCT06118411. Updated March 28, 2024. Accessed April 9, 2024. https://clinicaltrials.gov/study/NCT06118411
23.RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024.