Baseline Demographics and Severity and Burden of Atopic Dermatitis in Adult Patients Initiating Dupilumab Treatment in a Real-World Registry (PROSE)

Jerry Bagel, Tien Q Nguyen, Hermenio Lima, Neal Jain, David M Pariser, Sylvia Hsu, Gil Yosipovitch, Haixin Zhang, Jingdong Chao, Shikha Bansal, Zhen Chen, Daniel Richman, Andrew Korotzer, Marius Ardeleanu, Jerry Bagel, Tien Q Nguyen, Hermenio Lima, Neal Jain, David M Pariser, Sylvia Hsu, Gil Yosipovitch, Haixin Zhang, Jingdong Chao, Shikha Bansal, Zhen Chen, Daniel Richman, Andrew Korotzer, Marius Ardeleanu

Abstract

Introduction: Dupilumab was initially approved in 2017 as the first biologic therapy for atopic dermatitis (AD). We characterized adults with AD initiating dupilumab in a real-world setting in the USA/Canada.

Methods: PROSE is an ongoing, longitudinal, prospective, observational, multicenter registry of patients with AD initiating dupilumab per country-specific prescribing information. We report baseline data (day of first dupilumab injection) for patients enrolled from April 2018 through July 2019.

Results: Among 315 patients (mean age 42.5 years, 55.2% female), the median AD duration was 17.0 years; 65.4% reported a history of type 2 inflammatory comorbidities (e.g., allergic rhinitis, asthma), and 93.3% reported treatment(s) for AD in the previous year, including topical corticosteroids (90.8%), systemic corticosteroids (36.2%), and nonsteroidal systemic therapies (14.0%). In total, 89.2% had an Overall Disease Severity score of 3 (moderate) or 4 (severe). Other mean disease severity scores included the following: Eczema Area and Severity Index 16.9 (range 0-72), body surface area affected 26.8%, Patient-Oriented Eczema Measure 18.5 (range 0-28), Dermatology Life Quality Index 12.7 (range 0-30), and pruritus Numerical Rating Scale score 6.9 (range 0-10).

Conclusion: Patients initiating dupilumab have longstanding moderate-to-severe AD with significant disease burden and frequent type 2 comorbidities.

Gov identifier: NCT03428646.

Keywords: Atopic dermatitis; Baseline; Dupilumab; Eczema; Registry.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Disease characteristics (EASI, POEM, DLQI) by ODS. aEASI scale 0–72, with 0–1 indicating clear/almost clear; 1.1–7, mild; 7.1–21, moderate; 21.1–50, severe; and 50.1–72, very severe [24]. bPOEM scale 0–28, with 0–2 indicating clear/almost clear mild; 0–7 or 3–7, mild; 8–16 or 8–19, moderate; 17–24, 17–28, or 20–28, severe; 25–28, very severe [–27]. cDLQI scale 0–30, with 0–5 indicating mild; 6–10, moderate; 11–30, severe [26, 27]. DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, NA not available, ODS Overall Disease Severity, POEM Patient-Oriented Eczema Measure, PRO patient-reported outcome, SD standard deviation

References

    1. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109–1122. doi: 10.1016/S0140-6736(15)00149-X.
    1. Gittler JK, Shemer A, Suárez-Fariñas M, et al. Progressive activation of T(H)2/T(H)22 cytokines and selective epidermal proteins characterizes acute and chronic atopic dermatitis. J Allergy Clin Immunol. 2012;130(6):1344–1354. doi: 10.1016/j.jaci.2012.07.012.
    1. Boguniewicz M, Alexis AF, Beck LA, et al. Expert perspectives on management of moderate-to-severe atopic dermatitis: a multidisciplinary consensus addressing current and emerging therapies. J Allergy Clin Immunol Pract. 2017;5(6):1519–1531. doi: 10.1016/j.jaip.2017.08.005.
    1. Abuabara K, Yu AM, Okhovat JP, Allen IE, Langan SM. The prevalence of atopic dermatitis beyond childhood: a systematic review and meta-analysis of longitudinal studies. Allergy. 2018;73(3):696–704. doi: 10.1111/all.13320.
    1. Chan AR, Sandhu VK, Drucker AM, Fleming P, Lynde CW. Adult-onset atopic dermatitis: presentations and progress. J Cutan Med Surg. 2020;24(3):267–272. doi: 10.1177/1203475420911896.
    1. Garmhausen D, Hagemann T, Bieber T, et al. Characterization of different courses of atopic dermatitis in adolescent and adult patients. Allergy. 2013;68(4):498–506. doi: 10.1111/all.12112.
    1. Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic dermatitis in America study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population. J Invest Dermatol. 2019;139(3):583–590. doi: 10.1016/j.jid.2018.08.028.
    1. Birdi G, Cooke R, Knibb RC. Impact of atopic dermatitis on quality of life in adults: a systematic review and meta-analysis. Int J Dermatol. 2020;59(4):e75–91. doi: 10.1111/ijd.14763.
    1. Eckert L, Gupta S, Amand C, Gadkari A, Mahajan P, Gelfand JM. Impact of atopic dermatitis on health-related quality of life and productivity in adults in the United States: an analysis using the National Health and Wellness Survey. J Am Acad Dermatol. 2017;77(2):274–9.e273. doi: 10.1016/j.jaad.2017.04.019.
    1. Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345–360. doi: 10.1016/S0140-6736(20)31286-1.
    1. Macdonald LE, Karow M, Stevens S, et al. Precise and in situ genetic humanization of 6 Mb of mouse immunoglobulin genes. Proc Natl Acad Sci USA. 2014;111(14):5147–5152. doi: 10.1073/pnas.1323896111.
    1. Murphy AJ, Macdonald LE, Stevens S, et al. Mice with megabase humanization of their immunoglobulin genes generate antibodies as efficiently as normal mice. Proc Natl Acad Sci USA. 2014;111(14):5153–5158. doi: 10.1073/pnas.1324022111.
    1. Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287–2303. doi: 10.1016/S0140-6736(17)31191-1.
    1. Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335–2348. doi: 10.1056/NEJMoa1610020.
    1. de Bruin-Weller M, Thaci D, Smith CH, et al. Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFE) Br J Dermatol. 2018;178(5):1083–1101. doi: 10.1111/bjd.16156.
    1. 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.
    1. Paller AS, Siegfried EC, Thaçi D, et al. Efficacy and safety of dupilumab with concomitant topical corticosteroids in children 6 to 11 years old with severe atopic dermatitis: a randomized, double-blinded, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2020;83(5):1282–1293. doi: 10.1016/j.jaad.2020.06.054.
    1. Xiong XF, Zhu M, Wu HX, Fan LL, Cheng DY. Efficacy and safety of dupilumab for the treatment of uncontrolled asthma: a meta-analysis of randomized clinical trials. Respir Res. 2019;20(1):108. doi: 10.1186/s12931-019-1065-3.
    1. Bachert C, Mannent L, Naclerio RM, et al. Effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyposis: a randomized clinical trial. JAMA. 2016;315(5):469–479. doi: 10.1001/jama.2015.19330.
    1. Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019;394(10209):1638–1650. doi: 10.1016/S0140-6736(19)31881-1.
    1. Hirano I, Dellon ES, Hamilton JD, et al. Efficacy of dupilumab in a phase 2 randomized trial of adults with active eosinophilic esophagitis. Gastroenterology. 2020;158(1):111–22.e10. doi: 10.1053/j.gastro.2019.09.042.
    1. DUPIXENT (dupilumab). Highlights of prescribing information. United States Food and Drug Administration. 2021. . Accessed 27 Jan 2022.
    1. Dupixent® product monograph. Sanofi-aventis Canada Inc. 2021. . Accessed 27 Jan 2022.
    1. Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353–1357. doi: 10.1111/bjd.13662.
    1. Charman CR, Venn AJ, Ravenscroft JC, Williams HC. Translating Patient-Oriented Eczema Measure (POEM) scores into clinical practice by suggesting severity strata derived using anchor-based methods. Br J Dermatol. 2013;169(6):1326–1332. doi: 10.1111/bjd.12590.
    1. Silverberg JI, Gelfand JM, Margolis DJ, et al. Severity strata for POEM, PO-SCORAD, and DLQI in US adults with atopic dermatitis. Ann Allergy Asthma Immunol. 2018;121(4):464–8.e3. doi: 10.1016/j.anai.2018.07.004.
    1. Vakharia PP, Chopra R, Sacotte R, et al. Severity strata for five patient-reported outcomes in adults with atopic dermatitis. Br J Dermatol. 2018;178(4):925–930. doi: 10.1111/bjd.16078.
    1. Silverberg JI, Simpson EL, Ardeleanu M, et al. Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator's Global Assessment: a pooled analysis of data from two phase III trials. Br J Dermatol. 2019;181(1):80–87. doi: 10.1111/bjd.17791.
    1. Katoh N, Saeki H, Kataoka Y, et al. Atopic dermatitis disease registry in Japanese adult patients with moderate to severe atopic dermatitis (ADDRESS-J): baseline characteristics, treatment history and disease burden. J Dermatol. 2019;46(4):290–300. doi: 10.1111/1346-8138.14787.
    1. Bosma AL, de Wijs LEM, Hof MH, et al. Long-term effectiveness and safety of treatment with dupilumab in patients with atopic dermatitis: results of the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry. J Am Acad Dermatol. 2020;83(5):1375–1384. doi: 10.1016/j.jaad.2020.05.128.
    1. Silverberg JI, Simpson EL, Guttman-Yassky E, et al. Dupilumab significantly modulates pain and discomfort in patients with atopic dermatitis: a post hoc analysis of 5 randomized clinical trials. Dermatitis. 2021;32(1S):S81–S91. doi: 10.1097/DER.0000000000000698.
    1. Thaçi D, Simpson EL, Deleuran M, et al. Efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis: a pooled analysis of two phase 3 randomized trials (LIBERTY AD SOLO 1 and LIBERTY AD SOLO 2) J Dermatol Sci. 2019;94(2):266–275. doi: 10.1016/j.jdermsci.2019.02.002.

Source: PubMed

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