Dupilumab in the treatment of moderate-to-severe atopic dermatitis

References

• 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;132(5):1132–1138.
   PubMed Web of Science ®Google Scholar
• Harrop J, Chinn S, Verlato G, et al. Eczema, atopy and allergen exposure in adults: a population-based study. Clin Exp Allergy. 2007;37(4):526–535.
   PubMed Web of Science ®Google Scholar
• Plunkett A, Merlin K, Gill D, et al. The frequency of common nonmalignant skin conditions in adults in central Victoria, Australia. Int J Dermatol. 1999;38(12):901–908.
   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;124(6):1251–1258.
   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;131(1):67–73.
   PubMed Web of Science ®Google Scholar
• Schultz LF, Diepgen T, Svensson A. The occurrence of atopic dermatitis in north Europe: an international questionnaire study. J Am Acad Dermatol. 1996;34(5 Pt 1):760–764.
   PubMed Web of Science ®Google Scholar
• Bannister MJ, Freeman S. Adult-onset atopic dermatitis. Australas J Dermatol. 2000;41:225–228.
   PubMedGoogle Scholar
• Williams HC, Strachan DP. The natural history of childhood eczema: observations from the British 1958 birth cohort study. Br J Dermatol. 1998;139(5):834–839.
   PubMed Web of Science ®Google Scholar
• Margolis JS, Abuabara K, Bilker W, et al. Persistence of mild to moderate atopic dermatitis. JAMA Dermatol. 2014;150(6):593–600.
   PubMed Web of Science ®Google Scholar
• Spergel JM, Paller AS. Atopic dermatitis and the atopic march. J Allergy Clin Immunol. 2003;112(6 Suppl):S118–27.
   PubMed Web of Science ®Google Scholar
• Garg N, Silverberg JI. Epidemiology of childhood atopic dermatitis. Clin Dermatol. 2015;33(3):281–288.
   PubMed Web of Science ®Google Scholar
• Jackson KD, Howie LD, Akinbami LJ. Trends in allergic conditions among children: Unied States, 1997–2011. NCHS Data Brief. 2013;121:1–8.
   PubMedGoogle Scholar
• Hansen TE, Evjenth B, Holt J. Increasing prevalence of asthma, allergic rhinoconjunctivitis and eczema among schoolchildren: three surveys during the period 1985–2008. Acta Paediatr. 2013;102(1):47–52.
   PubMed Web of Science ®Google Scholar
• Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483–1494.
   PubMed Web of Science ®Google 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
• Boguniewicz M, Leung DY. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233–246.
   PubMed Web of Science ®Google Scholar
• Williams MR, Gallo RL. The role of the skin microbiome in atopic dermatitis. Curr Allergy Asthma Rep. 2015;15(11):65.
   PubMed Web of Science ®Google Scholar
• Cabanillas B, Novak N. Atopic dermatitis and filaggrin. Curr Opin Immunol. 2016;42:1–8.
   PubMed Web of Science ®Google Scholar
• Mansouri Y, Guttman-Yassky E. Immune pathways in atopic dermatitis, and definition of biomarkers through broad and targeted therapeutics. J Clin Med. 2015;4(5):858–873.
   PubMed Web of Science ®Google Scholar
• Brandt EB, Sivaprasad U. Th2 cytokines and atopic dermatitis. J Clin Cell Immunol. 2011;2(3):pii: 110.
   PubMedGoogle Scholar
• Williams HC. Clinical practice. Atopic dermatitis. N Engl J Med. 2005;352(22):2314–2324.
   PubMed Web of Science ®Google Scholar
• Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116–132.
   PubMed Web of Science ®Google Scholar
• Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014;71(2):327–349.
   PubMed Web of Science ®Google Scholar
• Ring J, Alomar A, Bieber T, et al. Guidelines for treatment of atopic eczema (atopic dermatitis) Part II. J Eur Acad Dermatol Venereol. 2012;26(9):1176–1193.
   PubMed Web of Science ®Google Scholar
• Saeki H, Nakahara T, Tanaka A, et al. Clinical practice guidelines for the management of atopic dermatitis 2016. J Dermatol. 2016;43(10):1117–1145.
   PubMed Web of Science ®Google Scholar
• Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218–1233.
   PubMed Web of Science ®Google Scholar
• Ring J, Alomar A, Bieber T, et al. Guidelines for treatment of atopic eczema (atopic dermatitis) part I. J Eur Acad Dermatol Venereol. 2012 Aug;26(8):1045–1060.
   PubMed Web of Science ®Google Scholar
• Heratizadeh A, Werfel T. Anti-inflammatory therapies in atopic dermatitis. Allergy. 2016;71(12):1666–1675.
   PubMed Web of Science ®Google Scholar
• Werfel T, Biedermann T. Current novel approaches in systemic therapy of atopic dermatitis: specific inhibition of cutaneous Th2 polarized inflammation and itch. Curr Opin Allergy Clin Immunol. 2015;15(5):446–452.
   PubMed Web of Science ®Google Scholar
• Beck LA, Thaçi D, Hamilton JD, et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014;371(2):130–139.
   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-4Rα, in atopic dermatitis patients and normal volunteers. CPT Pharmacometrics Syst Pharmacol. 2016;5(11):617–624.
   PubMedGoogle Scholar
• Berker M, Frank LJ, Geßner AL, et al. Allergies - A T cells perspective in the era beyond the TH1/TH2 paradigm. Clin Immunol. [cited 2016 Nov 12]. DOI:10.1016/j.clim.2016.11.001
   Google Scholar
• Mowen KA, Glimcher LH. Signaling pathways in Th2 development. Immunol Rev. 2004;202:203–222.
   PubMed Web of Science ®Google Scholar
• Hamilton JD, Ungar B, Guttman-Yassky E. Drug evaluation review: dupilumab in atopic dermatitis. Immunotherapy. 2015;7(10):1043–1058.
   PubMed Web of Science ®Google Scholar
• Howell MD, Kim BE, Gao P, et al. Cytokine modulation of atopic dermatitis filaggrin skin expression. J Allergy Clin Immunol. 2007;120(1):150–155.
   PubMed Web of Science ®Google Scholar
• Kim BE, Leung DY, Boguniewicz M, et al. Loricrin and involucrin expression is down-regulated by Th2 cytokines through STAT-6. Clin Immunol. 2008;126(3):332–337.
   PubMed Web of Science ®Google Scholar
• Zheng-Hong D, Lei M, Rui-Qun Q, et al. T Helper 1 and T Helper 2 cytokines differentially modulate expression of filaggrin and its processing proteases in human keratinocytes. Chin Med J (Engl). 2016;129(3):295–303.
   PubMed Web of Science ®Google Scholar
• Howell MD, Fairchild HR, Kim BE, et al. Th2 cytokines act on S100/A11 to downregulate keratinocyte differentiation. J Invest Dermatol. 2008;128(9):2248–2258.
   PubMed Web of Science ®Google Scholar
• Hönzke S, Wallmeyer L, Ostrowski A, et al. Influence of Th2 cytokines on the cornified envelope, tight junction proteins, and ß-defensins in filaggrin-deficient skin equivalents. J Invest Dermatol. 2016;136(3):631–639.
   PubMed Web of Science ®Google Scholar
• Hamilton JD, Suárez-Fariñas M, Dhingra N, et al. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014;134(6):1293–1300.
   PubMed Web of Science ®Google Scholar
• Thaçi 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;387(10013):40–52.
   PubMed Web of Science ®Google Scholar
• Simpson EL, Gadkari A, Worm M, et al. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): a phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD). J Am Acad Dermatol. 2016;75(3):506–515.
   PubMed Web of Science ®Google Scholar
• Simpson EL, Bieber T, Eckert L, et al. Patient burden of moderate to severe atopic dermatitis (AD): insights from a phase 2b clinical trial of dupilumab in adults. J Am Acad Dermatol. 2016;74(3):491–498.
   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 [cited 2016 Sep 30]. DOI:10.1056/NEJMoa1610020
   Web of Science ®Google Scholar
• Wenzel S, Ford L, Pearlman D, et al. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013;368(26):2455–2466.
   PubMed Web of Science ®Google Scholar
• Wenzel S, Castro M, Corren J, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388(10039):31–44.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov - A service of the U.S. National Institutes of Health [Internet]. Bethesda (MD): National Library of Medicine (US). [cited 2017 Jan 25]. Available from: https://clinicaltrials.gov
   Google Scholar
• Regeneron and sanofi announce dupilumab biologics license application accepted for priority review by U.S. FDA. Regeneron Pharmaceuticals, Inc., 2016 [cited 2016 Nov 30]. Available from: http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-dupilumab-biologics-license-application-accepted-for-priority-review-by-us-fda-300333529.html
   Google Scholar
• Pfizer receives FDA approval for EUCRISA™ (crisaborole), a novel non-steroidal topical ointment for mild to moderate atopic dermatitis (Eczema). Pfizer Inc., 2016 [cited 2017 Jan 25]. Available from: http://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_fda_approval_for_eucrisa_crisaborole_a_novel_non_steroidal_topical_ointment_for_mild_to_moderate_atopic_dermatitis_eczema
   Google Scholar
• EU Clinical Trials Register [Internet]. London: The European Medicines Agency. [cited 2017 Jan 25]. Available from: https://www.clinicaltrialsregister.eu
   Google Scholar