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Research Article

The clinical relevance of dupilumab serum concentration in patients with atopic dermatitis: a two-center prospective cohort study

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Article: 2193663 | Received 20 Feb 2023, Accepted 15 Mar 2023, Published online: 02 May 2023

References

  • Dupixent. Summary of product characteristics. 2017 [cited 2021 Feb 26]. Available from: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf
  • Dupixent. European public assessment report. 2017 [cited 2020 Sep 29]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/dupixent-epar-public-assessment-report_en.pdf
  • 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):​1–9.
  • Worm M, Simpson EL, Thaci D, et al. Efficacy and safety of multiple dupilumab dose regimens after initial successful treatment in patients With atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(2):131–143.
  • Deleuran M, Thaçi D, Beck LA, et al. Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study. J Am Acad Dermatol. 2020;82(2):377–388.
  • 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.
  • Bosma AL, Ouwerkerk W, Günal M, et al. Work ability and quality of working life in atopic dermatitis patients treated with dupilumab. J Dermatol. 2021;48(9):1305–1314.
  • Bosma AL, Ouwerkerk W, Heidema MJ, et al. Comparison of real-world treatment outcomes of systemic immunomodulating therapy in atopic dermatitis patients with dark and light skin types. JAAD Int. 2023;10:14–24.
  • Sears AV, Woolf RT, Gribaleva E, et al. Real-world effectiveness and tolerability of dupilumab in adult atopic dermatitis: a single-centre, prospective 1-year observational cohort study of the first 100 patients treated. Br J Dermatol. 2021;184(4):755–757.
  • Kovalenko P, Davis JD, Li M, et al. Base and covariate population pharmacokinetic analyses of dupilumab using phase 3 data. Clin Pharmacol Drug Dev. 2020;9(6):756–767.
  • Li Z, Radin A, Li M, et al. Pharmacokinetics, pharmacodynamics, safety, and tolerability of dupilumab in healthy adult subjects. Clin Pharmacol Drug Dev. 2020;9(6):742–755.
  • Dupixent. Dupixent (dupilumab)) injection for subcutaneous use highlights of prescribing information by Regeneron Pharmaceuticals. 2022 [cited 2011 Dec 30]. Available from: https://www.regeneron.com/downloads/dupixent_fpi.pdf.
  • Matera MG, Calzetta L, Rogliani P, et al. Monoclonal antibodies for severe asthma: pharmacokinetic profiles. Respir Med. 2019;153:3–13.
  • Eshtiaghi P, Gooderham MJ. Dupilumab: an evidence-based review of its potential in the treatment of atopic dermatitis. Core Evid. 2018;13:13–20.
  • Kamal MA, Davis JD, Kovalenko P, et al. Pharmacokinetics, pharmacodynamics, and exposure-efficacy of dupilumab in adults with atopic dermatitis. Clin Transl Sci. 2022;15(10):2342–2354.
  • Simpson EL, Akinlade B, Ardeleanu M. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2017;376(11):1090–1091.
  • Akinlade B, Guttman-Yassky E, de Bruin-Weller M, et al. Conjunctivitis in dupilumab clinical trials. Br J Dermatol. 2019;181(3):459–473.
  • Bansal A, Simpson EL, Paller AS, et al. Conjunctivitis in dupilumab clinical trials for adolescents with atopic dermatitis or asthma. Am J Clin Dermatol. 2021;22(1):101–115.
  • Menting SP, Coussens E, Pouw MF, et al. Developing a therapeutic range of adalimumab serum concentrations in management of psoriasis: a step Toward personalized treatment. JAMA Dermatol. 2015;151(6):616–622.
  • Williams HC, Burney PG, Pembroke AC, et al. The U.K. Working party’s diagnostic criteria for atopic dermatitis. III. Independent hospital validation. Br J Dermatol. 1994;131(3):406–416.
  • Schuttelaar MLA, De Bruin-Weller M, Oosting AJ, et al. Introduction of dupilumab for severe constitutional eczema. Ned Tijdschr Dermatol Venereol. 2018;28:56–57.
  • NICE. Dupilumab for treating moderate to severe atopic dermatitis: technology appraisal guidance. 2018 [cited 2022 Oct 13]. Available from: https://www.nice.org.uk/guidance/ta534/chapter/1-Recommendations
  • Gerbens LAA, Apfelbacher CJ, Irvine AD, et al. TREatment of ATopic eczema (TREAT) registry taskforce: an international delphi exercise to identify a core set of domains and domain items for national atopic eczema photo- and systemic therapy registries. Br J Dermatol. 2019;180(4):790–801.
  • Vermeulen FM, Gerbens LAA, Bosma AL, et al. TREatment of ATopic eczema (TREAT) registry taskforce: consensus on how and when to measure the core dataset for atopic eczema treatment research registries. Br J Dermatol. 2019;181(3):492–504.
  • Hanifin JM, Thurston M, Omoto M, et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI evaluator group. Exp Dermatol. 2001;10(1):11–18.
  • Yosipovitch G, Reaney M, Mastey V, et al. Peak pruritus numerical rating scale: psychometric validation and responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol. 2019;181(4):761–769.
  • Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients’ perspective. Arch Dermatol. 2004;140(12):1513–1519.
  • Finlay AY, Khan GK. Dermatology life quality index (DLQI)–a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210–216.
  • International Conference of Harmonization. Harmonised tripartite guideline. Clinical safety data management: definitions and standards for expedited reporting E2A. 2014 [cited 2020 March 13]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf
  • Großerichter-Wagener C, Kos D, van Leeuwen A, et al. Biased anti-idiotype response in rabbits leads to high-affinity monoclonal antibodies to biologics. MAbs. 2020;12(1):1814661.
  • Pouw MF, Krieckaert CL, Nurmohamed MT, et al. Key findings towards optimising adalimumab treatment: the concentration-effect curve. Ann Rheum Dis. 2015;74(3):513–518.
  • Chopra R, Vakharia PP, Sacotte R, et al. Severity strata for eczema area and severity index (EASI), modified EASI, scoring atopic dermatitis (SCORAD), objective SCORAD, atopic dermatitis severity index and body surface area in adolescents and adults with atopic dermatitis. Br J Dermatol. 2017;177(5):1316–1321.
  • De Bruin-Weller M, Biedermann T, Bissonnette R, et al. Treat-to-Target in atopic dermatitis: an international consensus on a set of core decision points for systemic therapies. Acta Derm Venereol. 2021;101(2):adv00402.
  • Menting SP, van den Reek JM, Baerveldt EM, et al. The correlation of clinical efficacy, serum trough levels and antidrug antibodies in ustekinumab-treated patients with psoriasis in a clinical-practice setting. Br J Dermatol. 2015;173(3):855–857.
  • Schram ME, Spuls PI, Leeflang MM, et al. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy. 2012;67(1):99–106.
  • Spekhorst LS, Bakker D, Drylewicz J, et al. Patient-centered dupilumab dosing regimen leads to successful dose reduction in persistently controlled atopic dermatitis. Allergy. 2022;77(11):3398–3407.