Dupilumab for the treatment of adolescents with atopic dermatitis

References

• Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483–1494.
   PubMed Web of Science ®Google Scholar
• Hanifin JM, Reed ML, Eczema P, et al. A population-based survey of eczema prevalence in the United States. Dermatitis. 2007 Jun;18(2):82–91.
   PubMed Web of Science ®Google Scholar
• Margolis DJ, Apter AJ, Gupta J, et al. The persistence of atopic dermatitis and filaggrin (FLG) mutations in a US longitudinal cohort. J Allergy Clin Immunol. 2012 Oct;130(4):912–917.
   PubMed Web of Science ®Google Scholar
• Odhiambo JA, Williams HC, Clayton TO, et al. Global variations in prevalence of eczema symptoms in children from ISAAC phase three. J Allergy Clin Immunol. 2009 Dec;124(6):1251–8 e23.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Hanifin JM. Adult eczema prevalence and associations with asthma and other health and demographic factors: a US population-based study. J Allergy Clin Immunol. 2013 Nov;132(5):1132–1138.
   PubMed Web of Science ®Google Scholar
• Shaw TE, Currie GP, Koudelka CW, et al. Eczema prevalence in the United States: data from the 2003 national survey of children’s health. J Invest Dermatol. 2011 Jan;131(1):67–73.
   PubMed Web of Science ®Google Scholar
• Huang E, Ong PY. Severe atopic dermatitis in children. Curr Allergy Asthma Rep. 2018 May 10;18(6):35.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Wetzel S, Burgdorf WH, et al. Viral infections in atopic dermatitis: pathogenic aspects and clinical management. J Allergy Clin Immunol. 2003 Oct;112(4):667–674.
   PubMed Web of Science ®Google Scholar
• Seegraber M, Worm M, Werfel T, et al. Recurrent eczema herpeticum - a retrospective European multicenter study evaluating the clinical characteristics of eczema herpeticum cases in atopic dermatitis patients. J Eur Acad Dermatol Venereol. 2020 May;34(5):1074–1079.
   Web of Science ®Google Scholar
• Regeneron Pharmaceuticals Inc. Regeneron and Sanofi Announce FDA approval of DUPIXENT® (dupilumab), the first targeted biologic therapy for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis. PR Newswire. 2017.
   Google Scholar
• Wollenberg A, Barbarot S, Bieber T, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2018 May;32(5):657–682.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Barbarot S, Bieber T, et al. Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II. J Eur Acad Dermatol Venereol. 2018 Jun;32(6):850–878.
   PubMed Web of Science ®Google Scholar
• De Benedetto A, Kubo A, Beck LA. Skin barrier disruption: a requirement for allergen sensitization? J Invest Dermatol. 2012 Mar;132(3 Pt 2):949–963.
   PubMed Web of Science ®Google Scholar
• Grimalt R, Mengeaud V, Cambazard F. The steroid-sparing effect of an emollient therapy in infants with atopic dermatitis: a randomized controlled study. Dermatology. 2007;214(1):61–67.
   PubMed Web of Science ®Google Scholar
• Lyons JJ, Milner JD, Stone KD. Atopic dermatitis in children: clinical features, pathophysiology, and treatment. Immunol Allergy Clin North Am. 2015 Feb;35(1):161–183.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Schnopp C. Evolution of conventional therapy in atopic dermatitis. Immunol Allergy Clin North Am. 2010 Aug;30(3):351–368.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Ehmann LM. Long term treatment concepts and proactive therapy for atopic eczema. Ann Dermatol. 2012 Aug;24(3):253–260.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Bieber T. Proactive therapy of atopic dermatitis–an emerging concept. Allergy. 2009 Feb;64(2):276–278.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Reitamo S, Girolomoni G, et al. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008 Jul;63(7):742–750.
   Web of Science ®Google Scholar
• Guttman-Yassky E, Hanifin JM, Boguniewicz M, et al. The role of phosphodiesterase 4 in the pathophysiology of atopic dermatitis and the perspective for its inhibition. Exp Dermatol. 2019 Jan;28(1):3–10.
   PubMed Web of Science ®Google Scholar
• Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016 Sep;75(3):494–503 e6.
   PubMed Web of Science ®Google Scholar
• Notaro ER, Sidbury R. Systemic agents for severe atopic dermatitis in children. Paediatr Drugs. 2015 Dec;17(6):449–457.
   PubMed Web of Science ®Google Scholar
• Regeneron. Dupixent® (dupilumab) prescribing information. 2019. Regeneron.
   Google Scholar
• Andrews R, Rosa L, Daines M, et al. Reconstitution of a functional human type II IL-4/IL-13 receptor in mouse B cells: demonstration of species specificity. J Immunol. 2001 Feb 01;166(3):1716–1722.
   PubMed Web of Science ®Google Scholar
• Bao L, Zhang H, Chan LS. The involvement of the JAK-STAT signaling pathway in chronic inflammatory skin disease atopic dermatitis. JAKSTAT. 2013 Jul 01;2(3):e24137.
   PubMedGoogle Scholar
• Werfel T, Allam JP, Biedermann T, et al. Cellular and molecular immunologic mechanisms in patients with atopic dermatitis. J Allergy Clin Immunol. 2016 Aug;138(2):336–349.
   PubMed Web of Science ®Google Scholar
• Esche C, de Benedetto A, Beck LA. Keratinocytes in atopic dermatitis: inflammatory signals. Curr Allergy Asthma Rep. 2004 Jul;4(4):276–284.
   PubMed Web of Science ®Google Scholar
• Bao L, Shi VY, Chan LS. IL-4 regulates chemokine CCL26 in keratinocytes through the Jak1, 2/Stat6 signal transduction pathway: implication for atopic dermatitis. Mol Immunol. 2012 Feb;50(1–2):91–97.
   PubMed Web of Science ®Google Scholar
• Chen L, Martinez O, Overbergh L, et al. Early up-regulation of Th2 cytokines and late surge of Th1 cytokines in an atopic dermatitis model. Clin Exp Immunol. 2004 Dec;138(3):375–387.
   PubMed Web of Science ®Google Scholar
• Kopf M, Le Gros G, Bachmann M, et al. Disruption of the murine IL-4 gene blocks Th2 cytokine responses. Nature. 1993 Mar 18;362(6417):245–248.
   PubMed Web of Science ®Google Scholar
• Pernis AB, Rothman PB. JAK-STAT signaling in asthma. J Clin Invest. 2002 May;109(10):1279–1283.
   PubMed Web of Science ®Google Scholar
• Yokota T, Otsuka T, Mosmann T, et al. Isolation and characterization of a human interleukin cDNA clone, homologous to mouse B-cell stimulatory factor 1, that expresses B-cell- and T-cell-stimulating activities. Proc Natl Acad Sci U S A. 1986 Aug;83(16):5894–5898.
   PubMed Web of Science ®Google Scholar
• McKenzie AN, Culpepper JA, de Waal Malefyt R, et al. Interleukin 13, a T-cell-derived cytokine that regulates human monocyte and B-cell function. Proc Natl Acad Sci U S A. 1993 Apr 15;90(8):3735–3739.
   PubMed Web of Science ®Google Scholar
• Cork MJ, Thaci D, Eichenfield LF, et al. Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: results from a phase IIa open-label trial and subsequent phase III open-label extension. Br J Dermatol. 2020 Jan;182(1):85–96.
   PubMed Web of Science ®Google Scholar
• Kovalenko P, DiCioccio AT, Davis JD, et al. Exploratory population PK analysis of dupilumab, a fully human monoclonal antibody against IL-4Ralpha, in atopic dermatitis patients and normal volunteers. CPT Pharmacometrics Syst Pharmacol. 2016 Nov;5(11):617–624.
   PubMedGoogle Scholar
• Wenzel S, Ford L, Pearlman D, et al. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013 Jun 27;368(26):2455–2466.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Oranje A, Deleuran M, et al. ETFAD/EADV Eczema task force 2015 position paper on diagnosis and treatment of atopic dermatitis in adult and paediatric patients. J Eur Acad Dermatol Venereol. 2016 May;30(5):729–747.
   PubMed Web of Science ®Google Scholar
• Thaci D, Simpson EL, Beck LA, et al. Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments: a randomised, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2016 Jan 02;387(10013):40–52.
   PubMed Web of Science ®Google Scholar
• 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 Dec 15;375(24):2335–2348.
   PubMed Web of Science ®Google Scholar
• 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.
   Web of Science ®Google Scholar
• Paller AS, Bansal A, Simpson EL, et al. Clinically meaningful responses to dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: post-hoc analyses from a randomized clinical trial. Am J Clin Dermatol. 2020;21:119–131.
   Web of Science ®Google Scholar
• Blauvelt A, Simpson EL, Tyring SK, et al. Dupilumab does not affect correlates of vaccine-induced immunity: A randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis. J Am Acad Dermatol. 2019 Jan;80(1):158–167 e1.
   PubMed Web of Science ®Google Scholar
• [updated 2020 Jul 1]. Available from: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf
   Google Scholar
• Vestergaard C, Wollenberg A, Barbarot S, et al. European task force on atopic dermatitis position paper: treatment of parental atopic dermatitis during preconception, pregnancy and lactation period. J Eur Acad Dermatol Venereol. 2019 Sep;33(9):1644–1659.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Flohr C, Simon D, et al. European task force on atopic dermatitis (ETFAD) statement on severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)-infection and atopic dermatitis. J Eur Acad Dermatol Venereol. 2020 Mar 29. DOI:10.1111/jdv.16411
   Web of Science ®Google Scholar
• Beck LA, Thaci D, Hamilton JD, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130–139.
   PubMed Web of Science ®Google Scholar
• 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 Jun 10;389(10086):2287–2303.
   PubMed Web of Science ®Google Scholar
• de Bruin-weller M, Thaci D, Smith CH, et al. Dupilumab with concomitant topical corticosteroids in adult patients with atopic dermatitis who are not adequately controlled with or are intolerant to ciclosporin A, or when this treatment is medically inadvisable: a placebo-controlled, randomized phase 3 clinical trial (LIBERTY AD CAFE). Br J Dermatol. 2018 May;178(5):1083–1101..
   Web of Science ®Google Scholar
• [updated 2020 Jul 1; cited 2020 Jul 1]. Available from: https://www.sanofi.com/en/media-room/press-releases/2020/2020-05-26-17-40-00
   Google Scholar
• Cork MJ, Eckert L, Simpson EL, et al. Dupilumab improves patient-reported symptoms of atopic dermatitis, symptoms of anxiety and depression, and health-related quality of life in moderate-to-severe atopic dermatitis: analysis of pooled data from the randomized trials SOLO 1 and SOLO 2. J Dermatolog Treat. 2019;9:1–9.
   Web of Science ®Google Scholar
• Akinlade B, Guttman-Yassky E, de Bruin-weller M, et al. Conjunctivitis in dupilumab clinical trials. Br J Dermatol. 2019 Sep;181(3):459–473.
   PubMed Web of Science ®Google Scholar
• Aszodi N, Thurau S, Seegraber M, et al. Management of dupilumab-associated conjunctivitis in atopic dermatitis. J Dtsch Dermatol Ges. 2019 May;17(5):488–491.
   Web of Science ®Google Scholar
• Wollenberg A, Beck LA, Blauvelt A, et al. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol. 2020 May;182(5):1120–1135..
   Web of Science ®Google Scholar
• Senner S, Eicher L, Aszodi N, et al. Psoriasis in dupilumab-treated atopic dermatitis. Hautarzt. 2020 Mar;16(71):383–386.
   Web of Science ®Google Scholar
• Varma A, Levitt J. Dupilumab-induced phenotype switching from atopic dermatitis to psoriasis. JAAD Case Rep. 2020 Mar;6(3):217–218.
   PubMedGoogle Scholar
• Ruzicka T, Hanifin JM, Furue M, et al. Anti-interleukin-31 receptor a antibody for atopic dermatitis. N Engl J Med. 2017 Mar 02;376(9):826–835.
   PubMed Web of Science ®Google Scholar
• Kabashima K, Furue M, Hanifin JM, et al. Nemolizumab in patients with moderate-to-severe atopic dermatitis: randomized, phase II, long-term extension study. J Allergy Clin Immunol. 2018 Oct;142(4):1121–1130 e7.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Pinter A, Pulka G, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173–182.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Howell MD, Guttman-Yassky E, et al. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol. 2019 Jan;143(1):135–141.
   PubMed Web of Science ®Google Scholar
• Guttman-Yassky E, Blauvelt A, Eichenfield LF, et al. Efficacy and safety of lebrikizumab, a high-affinity interleukin 13 inhibitor, in adults with moderate to severe atopic dermatitis: a phase 2b randomized clinical trial. JAMA Dermatol. 2020 Feb;156(4):411–420.
   PubMed Web of Science ®Google Scholar
• Cotter DG, Schairer D, Eichenfield L. Emerging therapies for atopic dermatitis: JAK inhibitors. J Am Acad Dermatol. 2018 Mar;78(3 Suppl 1):S53–S62.
   PubMed Web of Science ®Google Scholar
• Simpson EL, Lacour JP, Spelman L, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol. 2020 Aug;183(2):242–255.
   Google Scholar
• Gooderham MJ, Forman SB, Bissonnette R, et al. Efficacy and safety of oral janus kinase 1 inhibitor abrocitinib for patients with atopic dermatitis: a phase 2 randomized clinical trial. JAMA Dermatol. 2019 Oct 2;156(1):104–104.
   PubMed Web of Science ®Google Scholar
• Thurmond RL. The histamine H4 receptor: from orphan to the clinic. Front Pharmacol. 2015;6:65.
   PubMed Web of Science ®Google Scholar
• Eicher L, Knop M, Aszodi N, et al. A systematic review of factors influencing treatment adherence in chronic inflammatory skin disease - strategies for optimizing treatment outcome. J Eur Acad Dermatol Venereol. 2019 Dec;33(12):2253–2263.
   PubMed Web of Science ®Google Scholar
• Spekhorst LS, Ariens LFM, van der Schaft J, et al. Two-year drug survival of dupilumab in a large cohort of difficult-to-treat adult atopic dermatitis patients compared to cyclosporine A and methotrexate: results from the BioDay registry. Allergy. 2020 Apr 17. DOI:10.1111/all.14324
   PubMed Web of Science ®Google Scholar
• Deleanu D, Nedelea I. Biological therapies for atopic dermatitis: an update. Exp Ther Med. 2019 Feb;17(2):1061–1067.
   PubMed Web of Science ®Google Scholar
• Rodrigues MA, Torres T. JAK/STAT inhibitors for the treatment of atopic dermatitis. J Dermatolog Treat. 2020 Feb;31(1):33–40.
   PubMed Web of Science ®Google Scholar