Baricitinib for the treatment of atopic dermatitis

References

• Deckers IA, McLean S, Linssen S, et al. Investigating international time trends in the incidence and prevalence of atopic eczema 1990-2010: a systematic review of epidemiological studies. PLoS One. 2012;7(7):e39803.
   PubMed Web of Science ®Google Scholar
• Bieber T. Atopic dermatitis. N Engl J Med. 2008;358(14):1483–1494.
   PubMed Web of Science ®Google Scholar
• Williams H. Atopic dermatitis: the epidemiology, causes and prevention of atopic eczema. Cambridge: Cambridge University Press, pp.25–38. 2000.
   Google Scholar
• Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(Suppl 1):8–16.
   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;35(1):161–183.
   PubMed Web of Science ®Google Scholar
• Ozkaya E. Adult-onset atopic dermatitis. J Am Acad Dermatol. 2005;52(4):579–582.
   PubMed Web of Science ®Google Scholar
• Bannister MJ, Freeman S. Adult-onset atopic dermatitis. Australas J Dermatol. 2000;41(4):225–228.
   PubMedGoogle Scholar
• Silverberg JI. Comorbidities and the impact of atopic dermatitis. Ann Allergy Asthma Immunol. 2019;123(2):144–151.
   PubMed Web of Science ®Google Scholar
• Drucker AM, Wang AR, Li WQ, et al. The burden of atopic dermatitis: Summary of a report for the national eczema association. J Invest Dermatol. 2017;137(1):26–30.
   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.; American Academy of Dermatology. 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
• Flohr C, Irvine AD. Systemic therapies for severe atopic dermatitis in children and adults. J Allergy Clin Immunol. 2013;132(3):774–7e6.
   PubMed Web of Science ®Google Scholar
• Weidinger S, Baurecht H, Schmitt J. A 5-year randomized trial on the safety and efficacy of pimecrolimus in atopic dermatitis: a critical appraisal. Br J Dermatol. 2017;177(4):999–1003.
   PubMed Web of Science ®Google Scholar
• Barnes L, Kaya G, Rollason V. Topical corticosteroid-induced skin atrophy: a comprehensive review. Drug Saf. 2015;38(5):493–509.
   PubMed Web of Science ®Google Scholar
• Levin E, Gupta R, Butler D, et al. Topical steroid risk analysis: differentiating between physiologic and pathologic adrenal suppression. J Dermatolog Treat. 2014;25(6):501–506.
   PubMed Web of Science ®Google Scholar
• Weidinger S, Beck LA, Bieber T, et al. Atopic dermatitis. Nat Rev Dis Primers. 2018;4(1):1.
   PubMed Web of Science ®Google Scholar
• Nakahara T, Morimoto H, Murakami N, et al. Mechanistic insights into topical tacrolimus for the treatment of atopic dermatitis. Pediatr Allergy Immunol. 2018;29(3):233–238.
   PubMed Web of Science ®Google Scholar
• Ashcroft DM, Dimmock P, Garside R, et al. Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: Meta-analysis of randomised controlled trials. BMJ. 2005;330(7490):516.
   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 I. 2018. May. Report No.: 0926-9959 Contract No.: 5.
   Google Scholar
• Simon D, Bieber T. Systemic therapy for atopic dermatitis. Allergy. 2014;69(1):46–55.
   PubMed Web of Science ®Google Scholar
• Roekevisch E, Spuls PI, Kuester D, et al. Efficacy and safety of systemic treatments for moderate-to-severe atopic dermatitis: a systematic review. J Allergy Clin Immunol. 2014;133(2):429–438.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Barbarot S, Bieber T, et al.; European Dermatology Forum (EDF), the European Academy of Dermatology and Venereology (EADV), the European Academy of Allergy and Clinical Immunology (EAACI), the European Task Force on Atopic Dermatitis (ETFAD), European Federation of Allergy and Airways Diseases Patients’ Associations (EFA), the European Society for Dermatology and Psychiatry (ESDaP), the European Society of Pediatric Dermatology (ESPD), Global Allergy and Asthma European Network (GA2LEN) and the European Union of Medical Specialists (UEMS). Consensus-based european guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II. J Eur Acad Dermatol Venereol. 2018;32(6):850–878.
   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;389(10086):2287–2303.
   PubMed Web of Science ®Google Scholar
• Ferreira S, Torres T. Dupilumab for the treatment of atopic dermatitis. Actas Dermosifiliogr (Engl Ed)). 2018;109(3):230–240.
   PubMed Web of Science ®Google Scholar
• Kalamaha K, Reis E, Newton S, et al. Atopic dermatitis: a review of evolving targeted therapies. Expert Rev Clin Immunol. 2019;15(3):275–288.
   PubMed Web of Science ®Google Scholar
• Silverberg JI, Guttman-Yassky E, Gadkari A, et al. Real-world persistence with dupilumab among adults with atopic dermatitis. Ann Allergy Asthma Immunol. 2021;126(1):40–45.
   PubMed Web of Science ®Google Scholar
• Ferreira S, Guttman-Yassky E, Torres T. Selective JAK1 inhibitors for the treatment of atopic dermatitis: Focus on upadacitinib and abrocitinib. Am J Clin Dermatol. 2020;21(6):783–798.
   PubMed Web of Science ®Google Scholar
• Kontzias A, Kotlyar A, Laurence A, et al. Jakinibs: a new class of kinase inhibitors in cancer and autoimmune disease. Curr Opin Pharmacol. 2012;12(4):464–470.
   PubMed Web of Science ®Google Scholar
• Schwartz DM, Kanno Y, Villarino A, et al. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nat Rev Drug Discov. 2017;17(1):78.
   PubMed Web of Science ®Google Scholar
• Kubo S, Nakayamada S, Sakata K, et al. Janus kinase inhibitor baricitinib modulates human innate and adaptive immune system. Front Immunol. 2018;9:1510.
   PubMed Web of Science ®Google Scholar
• Kuo IH, Yoshida T, De Benedetto A, et al. The cutaneous innate immune response in patients with atopic dermatitis. J Allergy Clin Immunol. 2013;131(2):266–278.
   PubMed Web of Science ®Google Scholar
• Boguniewicz M, Leung DYM. Atopic dermatitis: a disease of altered skin barrier and immune dysregulation. Immunol Rev. 2011;242(1):233–246.
   PubMed Web of Science ®Google Scholar
• Silverberg NB, Silverberg JI. Inside out or outside in: does atopic dermatitis disrupt barrier function or does disruption of barrier function trigger atopic dermatitis? Cutis. 2015;96(6):359–361.
   PubMed Web of Science ®Google Scholar
• Leung DYM, Guttman-Yassky E. Deciphering the complexities of atopic dermatitis: shifting paradigms in treatment approaches. J Allergy Clin Immunol. 2014;134(4):769–779.
   PubMed Web of Science ®Google Scholar
• Seidenari S, Giusti G. Objective assessment of the skin of children affected by atopic dermatitis: a study of pH, capacitance and TEWL in eczematous and clinically uninvolved skin. Acta Derm Venereol. 1995;75(6):429–433.
   PubMed Web of Science ®Google Scholar
• Flohr C, England K, Radulovic S, et al. Filaggrin loss-of-function mutations are associated with early-onset eczema, eczema severity and transepidermal water loss at 3 months of age. Br J Dermatol. 2010;163(6):1333–1336.
   PubMed Web of Science ®Google Scholar
• Gupta J, Grube E, Ericksen MB, et al. Intrinsically defective skin barrier function in children with atopic dermatitis correlates with disease severity. J Allergy Clin Immunol. 2008;121(3):725–730.e2.
   PubMed Web of Science ®Google Scholar
• Leung DY. New insights into atopic dermatitis: role of skin barrier and immune dysregulation. Allergol Int. 2013;62(2):151–161.
   PubMed Web of Science ®Google Scholar
• Irvine AD, McLean WH, Leung DY. Filaggrin mutations associated with skin and allergic diseases. N Engl J Med. 2011;365(14):1315–1327.
   PubMed Web of Science ®Google Scholar
• Palmer CN, Irvine AD, Terron-Kwiatkowski A, et al. Common loss-of-function variants of the epidermal barrier protein filaggrin are a major predisposing factor for atopic dermatitis. Nat Genet. 2006;38(4):441–446.
   PubMed Web of Science ®Google Scholar
• Hvid M, Vestergaard C, Kemp K, et al. IL-25 in atopic dermatitis: a possible link between inflammation and skin barrier dysfunction? J Invest Dermatol. 2011;131(1):150–157.
   PubMed Web of Science ®Google Scholar
• Savinko T, Matikainen S, Saarialho-Kere U, et al. IL-33 and ST2 in atopic dermatitis: Expression profiles and modulation by triggering factors. J Invest Dermatol. 2012;132(5):1392–1400.
   PubMed Web of Science ®Google Scholar
• Soumelis V, Reche PA, Kanzler H, et al. Human epithelial cells trigger dendritic cell mediated allergic inflammation by producing TSLP. Nat Immunol. 2002;3(7):673–680.
   PubMed Web of Science ®Google Scholar
• Brandt EB, Sivaprasad U. Th2 cytokines and atopic dermatitis. J Clin Cell Immunol. 2011;2(3):110.
   PubMedGoogle Scholar
• Margolis DJ, Kim B, Apter AJ, et al. Thymic stromal lymphopoietin variation, filaggrin loss of function, and the persistence of atopic dermatitis. JAMA Dermatol. 2014;150(3):254–259.
   PubMed Web of Science ®Google Scholar
• McGirt LY, Beck LA. Innate immune defects in atopic dermatitis. J Allergy Clin Immunol. 2006;118(1):202–208.
   PubMed Web of Science ®Google Scholar
• Ong PY, Ohtake T, Brandt C, et al. Endogenous antimicrobial peptides and skin infections in atopic dermatitis. N Engl J Med. 2002;347(15):1151–1160.
   PubMed Web of Science ®Google Scholar
• Cardona ID, Cho SH, Leung DY. Role of bacterial superantigens in atopic dermatitis : implications for future therapeutic strategies. Am J Clin Dermatol. 2006;7(5):273–279.
   PubMed Web of Science ®Google Scholar
• Fiset PO, Leung DY, Hamid Q. Immunopathology of atopic dermatitis. J Allergy Clin Immunol. 2006;118(1):287–290.
   PubMed Web of Science ®Google Scholar
• Czarnowicki T, Krueger JG, Guttman-Yassky E. Skin barrier and immune dysregulation in atopic dermatitis: an evolving story with important clinical implications. J Allergy Clin Immunol Pract. 2014;2(4):371–379. quiz 80-1.
   PubMed Web of Science ®Google Scholar
• Oliva M, Renert-Yuval Y, Guttman-Yassky E. The 'omics' revolution: redefining the understanding and treatment of allergic skin diseases. Curr Opin Allergy Clin Immunol. 2016;16(5):469–476.
   PubMed Web of Science ®Google Scholar
• Danso MO, van Drongelen V, Mulder A, et al. TNF-α and Th2 cytokines induce atopic dermatitis-like features on epidermal differentiation proteins and stratum corneum lipids in human skin equivalents. J Invest Dermatol. 2014;134(7):1941–1950.
   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
• Nograles KE, Zaba LC, Shemer A, et al. IL-22-producing "T22" T cells account for upregulated IL-22 in atopic dermatitis despite reduced IL-17-producing TH17 T cells. J Allergy Clin Immunol. 2009;123(6):1244–1252.e2.
   PubMed Web of Science ®Google Scholar
• Gutowska-Owsiak D, Schaupp AL, Salimi M, et al. IL-17 downregulates filaggrin and affects keratinocyte expression of genes associated with cellular adhesion. Exp Dermatol. 2012;21(2):104–110.
   PubMed Web of Science ®Google Scholar
• Wolk K, Witte E, Wallace E, et al. IL-22 regulates the expression of genes responsible for antimicrobial defense, cellular differentiation, and mobility in keratinocytes: a potential role in psoriasis. Eur J Immunol. 2006;36(5):1309–1323.
   PubMed Web of Science ®Google Scholar
• Hijnen D, De Bruin-Weller M, Oosting B, et al. Serum thymus and activation-regulated chemokine (TARC) and cutaneous T cell- attracting chemokine (CTACK) levels in allergic diseases: TARC and CTACK are disease-specific markers for atopic dermatitis. J Allergy Clin Immunol. 2004;113(2):334–340.
   PubMed Web of Science ®Google Scholar
• Novak N, Kraft S, Geiger E, et al. Dichotomic nature of atopic dermatitis reflected by combined analysis of monocyte immunophenotyping and single nucleotide polymorphisms of the interleukin-4/interleukin-13 receptor gene: the dichotomy of extrinsic and intrinsic atopic dermatitis. J Invest Dermatol. 2002;119(4):870–875.
   PubMed Web of Science ®Google Scholar
• He JQ, Chan-Yeung M, Becker AB, et al. Genetic variants of the IL13 and IL4 genes and atopic diseases in at-risk children. Genes Immun. 2003;4(5):385–389.
   PubMed Web of Science ®Google Scholar
• Lesiak A, Kuna P, Zakrzewski M, et al. Combined occurrence of filaggrin mutations and IL-10 or IL-13 polymorphisms predisposes to atopic dermatitis. Exp Dermatol. 2011;20(6):491–495.
   PubMed Web of Science ®Google Scholar
• Namkung JH, Lee JE, Kim E, et al. Association of polymorphisms in genes encoding IL-4, IL-13 and their receptors with atopic dermatitis in a korean population. Exp Dermatol. 2011;20(11):915–919.
   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. 2009;124(3):R7–r12. Suppl 2.
   PubMed Web of Science ®Google Scholar
• Bieber T. Atopic dermatitis. Ann Dermatol. 2010;22(2):125–137.
   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;2(3):e24137.
   PubMedGoogle Scholar
• Villarino AV, Kanno Y, O'Shea JJ. Mechanisms and consequences of Jak-STAT signaling in the immune system. Nat Immunol. 2017;18(4):374–384.
   PubMed Web of Science ®Google Scholar
• O'Shea JJ, Schwartz DM, Villarino AV, et al. The JAK-STAT pathway: impact on human disease and therapeutic intervention. Annu Rev Med. 2015;66:311–328.
   PubMed Web of Science ®Google Scholar
• Ghoreschi K, Gadina M. Jakpot! new small molecules in autoimmune and inflammatory diseases. Exp Dermatol. 2014;23(1):7–11.
   PubMed Web of Science ®Google Scholar
• Rawlings JS, Rosler KM, Harrison DA. The JAK/STAT signaling pathway. J Cell Sci. 2004;117(Pt 8):1281–1283.
   PubMed Web of Science ®Google Scholar
• Bousoik E, Montazeri Aliabadi H. "Do We Know Jack" About JAK? A Closer Look at JAK/STAT Signaling Pathway”. Front Oncol. 2018;8:287.
   PubMed Web of Science ®Google Scholar
• Gandhi NA, Bennett BL, Graham NM, et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15(1):35–50.
   PubMed Web of Science ®Google Scholar
• He H, Guttman-Yassky E. JAK inhibitors for atopic dermatitis: an update. Am J Clin Dermatol. 2019;20(2):181–192.
   PubMed Web of Science ®Google Scholar
• Di Salvo E, Ventura-Spagnolo E, Casciaro M, et al. IL-33/IL-31 axis: a potential inflammatory pathway. Mediators Inflamm. 2018;2018:3858032.
   PubMed Web of Science ®Google Scholar
• Rodrigues MA, Torres T. The changing landscape of atopic Dermatitis - Focusing on JAK inhibitors. Eur Ann Allergy Clin Immunol. 2020;52(1):45–48.
   PubMed Web of Science ®Google Scholar
• Baricitinib | C16H17N7O2S - PubChem [Internet]. [cited 2021 Apr 16]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/44205240.
   Google Scholar
• Shi JG, Chen X, Lee F, et al. The pharmacokinetics, pharmacodynamics, and safety of baricitinib, an oral JAK 1/2 inhibitor, in healthy volunteers. J Clin Pharmacol. 2014;54(12):1354–1361.
   PubMed Web of Science ®Google Scholar
• Markham A. Baricitinib: first global approval. Drugs. 2017;77(6):697–704.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Baricitinib (Olumiant): summary of product characteristics; 2017. Available from: https://www.ema.europa.eu/en/documents/product-information/olumiant-epar-product-information_en.pdf. Accessed April 25, 2021.
   Google Scholar
• Guttman-Yassky E, Silverberg JI, Nemoto O, et al. Baricitinib in adult patients with moderate-to-severe atopic dermatitis: a phase 2 parallel, double-blinded, randomized placebo-controlled multiple-dose study. J Am Acad Dermatol. 2019;80(4):913–921.e9.
   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;183(2):242–255.
   PubMed Web of Science ®Google Scholar
• Reich K, Kabashima K, Peris K, et al. Efficacy and safety of baricitinib combined with topical corticosteroids for treatment of moderate to severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. 2020;156(12):1333–1343.
   PubMed Web of Science ®Google Scholar
• Simpson EL, Forman S, Silverberg JI, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy phase 3 trial in the United States and Canada (BREEZE-AD5). J Am Acad Dermatol. 2021;85(1):62–70.
   PubMed Web of Science ®Google Scholar
• Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids in Patients with Moderate to Severe Atopic Dermatitis Not Controlled with Cyclosporine | Eli Lilly and Company [Internet]. [cited 2021 May 2]. Available from: https://investor.lilly.com/news-releases/news-release-details/lilly-and-incyte-announce-top-line-results-phase-3-study-breeze.
   Google Scholar
• Silverberg JI, Simpson EL, Wollenberg A, et al. Long-term efficacy of baricitinib in adults with moderate to severe atopic dermatitis who were treatment responders or partial responders: an extension study of 2 randomized clinical trials. JAMA Dermatol. 2021;157(6):691–699.
   PubMed Web of Science ®Google Scholar
• Bieber T, Thyssen JP, Reich K, et al. Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials. J Eur Acad Dermatol Venereol. 2021;35(2):476–485.
   PubMed Web of Science ®Google Scholar