Safety update of etanercept treatment for moderate to severe plaque psoriasis

References

• Goff KL, Karimkhani C, Boyers LN, et al. The global burden of psoriatic skin disease. Br J Dermatol. 2015;172(6):1665–1668.
   PubMed Web of Science ®Google Scholar
• Sarac G, Koca TT, Baglan T. A short summary of clinical types of psoriasis. North Clin Istanbul. 2016;3(1):79–82.
   PubMed Web of Science ®Google Scholar
• Biasi D, Caramaschi P. Psoriatic Arthritis. Best Pract Res Clin Rheumatol. 2012;26(1):147–156.
   PubMed Web of Science ®Google Scholar
• Veale DJ, Fearon U. The pathogenesis of psoriatic arthritis. Lancet. 2018;2(391):2273–2284.
   Google Scholar
• Ganzetti G, Campanati A, Molinelli E, et al. Psoriasis, non-alcoholic fatty liver disease, and cardiovascular disease: three different diseases on a unique background. World J Cardiol. 2016;8(2):120–131.
   PubMed Web of Science ®Google Scholar
• Bacchetti T, Campanati A, Ferretti G, et al. Oxidative stress and psoriasis: the effect of antitumour necrosis factor-(alpha) inhibitor treatment. Br J Dermatol. 2013;168(5):984–989.
   PubMed Web of Science ®Google Scholar
• Marra M, Campanati A, Testa R, et al. Effect of Etanercept on insulin sensitivity in nine patients with psoriasis. Int J Immunopathol Pharmacol. 2007;20(4):731–736.
   PubMed Web of Science ®Google Scholar
• Gisondi P, Cazzaniga S, Chimenti S, et al. Metabolic abnormalities associated with initiation of systemic treatment for psoriasis: evidence from the Italian Psocare Registry. J Eur Acad Dermatol Venereol. 2013;27(1):30–41.
   PubMed Web of Science ®Google Scholar
• Giannoni M, Consales V, Campanati A, et al. Homocysteine plasma levels in psoriasis patients: our experience and review of the literature. J Eur Acad Dermatol Venereol. 2015;29(9):1781–1785.
   PubMed Web of Science ®Google Scholar
• Xu X, Zhang HY. The immunogenetics of psoriasis and implications for drug repositioning. Int J Mol Sci. 2017;18(12):2650.
   Web of Science ®Google Scholar
• Orciani M, Campanati A, Salvolini E, et al. The mesenchymal stem cell profile in psoriasis. Br J Dermatol. 2011;165(3):585–592.
   PubMed Web of Science ®Google Scholar
• Alwan W, Nestle FO. Pathogenesis and treatment of psoriasis: exploiting pathophysiological pathways for precision medicine. Clin Exp Rheumatol. 2015;33(5 suppl 93):S2S6.
   Web of Science ®Google Scholar
• Rendon A, Schäkel K. Psoriasis pathogenesis and treatment. Int J Mol Sci. 2019;20(6):1475.
   PubMed Web of Science ®Google Scholar
• Albanesi C. Immunology of psoriasis. In: Clinical immunology: principles and practice. 4th ed. Elsevier Inc. 2012. p. 775–781.
   Google Scholar
• Lubberts E. The IL-23-IL-17 axis in inflammatory arthritis. Nat Rev Rheumatol. 2015;11(7):415–429.
   PubMed Web of Science ®Google Scholar
• Eer G, Kolch W, Scheurich P. Ligands working as receptors: reverse signaling by members of the TNF superfamily enhance the plasticity of the immune system. Cytokine Growth Factor Rev. 2004;15(5):353–366.
   PubMed Web of Science ®Google Scholar
• Yost J, Gudjonsson JE. The role of TNF inhibitors in psoriasis therapy. Med Rep. 2009;1:30.
   Google Scholar
• Rossi R, Calzavara-Pinton PG, Giannetti A, et al. Italian guidelines and therapeutic algorithm for actinic keratoses. G Ital Dermatol Venereol. 2009 Dec cited 2015 Jul 3;144(6):713–723. [Internet]. [];():. Available from.: http://www.ncbi.nlm.nih.gov/pubmed/19907409
   PubMed Web of Science ®Google Scholar
• Diotallevi F, Campanati A, Radi G, et al. Ixekizumab for treatment of moderate to severe plaque psoriasis: real world clinical experience. G Ital Dermatol Venereol. 2018 Nov 9 Epub ahead of print. DOI:10.23736/S0392-0488.18.06094-7
   Google Scholar
• Rønholt K, Iversen L. Old and new biological therapies for psoriasis. Int J Mol Sci. 2017;18:11.
   Web of Science ®Google Scholar
• Radi G, Campanati A, Diotallevi F, et al. Skin involvement in patients with psoriatic arthritis: preliminary results of treatment with apremilast in real world setting. G Ital Dermatol Venereol. 2019;154(2):166–169.
   PubMed Web of Science ®Google Scholar
• Vergou T, Moustou AE, Sfikakis PP, et al. Pharmacodynamics of TNF-α inhibitors in psoriasis. Expert Rev Clin Pharmacol. 2011;4(4):515–523.
   PubMedGoogle Scholar
• Campanati A, Orciani M, Gorbi S, et al. Effect of biologic therapies targeting tumour necrosis factor-α on cutaneous mesenchymal stem cells in psoriasis. Br J Dermatol. 2012;167(1):68–76.
   PubMed Web of Science ®Google Scholar
• Piaserico S, Cazzaniga S, Chimenti S, et al. Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian psocare registry. J Am Acad Dermatol. 2014;26(4):319–324.
   Google Scholar
• Campanati A, Orciani M, Lazzarini R, et al. TNF-α inhibitors reduce the pathological Th1–Th17/Th2 imbalance in cutaneous mesenchymal stem cells of psoriasis patients. Exp Dermatol. 2017;26(4):319–324.
   PubMed Web of Science ®Google Scholar
• Campanati A, Paolinelli M, Diotallevi F, et al. Pharmacodynamics OF TNF α inhibitors for the treatment of psoriasis. Expert Opin Drug Metab Toxicol. 2019;8(2):120–131.
   Google Scholar
• Peppel K, Crawford D, Beutler B. A tumor necrosis factor (TNF) receptor-IgG heavy chain chimeric protein as a bivalent antagonist of TNF activity. J Exp Med. 1991;174(6):1483–1489.
   PubMed Web of Science ®Google Scholar
• Tyring S, Gordon KB, Poulin Y, et al. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007;143(6):719–726.
   PubMed Web of Science ®Google Scholar
• Alwawi EA, Krulig E, Gordon KB. Long-term efficacy of biologics in the treatment of psoriasis: what do we really know? Dermatol Ther. 2009;22(5):431–440.
   PubMed Web of Science ®Google Scholar
• Gatti J, Lindstrom JA, Beitz J. Reconsideration of 2008 decision: food and Drug Administration approval of etanercept for systemic treatment of moderate to severe pediatric psoriasis. Pediatr Dermatol. 2018;35(5):688–689.
   PubMed Web of Science ®Google Scholar
• Thomson A, Chrisp P. Etanercept in psoriasis: the evidence of its therapeutic impact. Core Evid. 2007;2(1):51–62.
   PubMedGoogle Scholar
• Murdaca G, Spanò F, Contatore M, et al. Pharmacogenetics of etanercept: role of TNF-α gene polymorphisms in improving its efficacy. Expert Opin Drug Metab Toxicol. 2014;10(12):17.
   Web of Science ®Google Scholar
• Goffe B, Cather JC. Etanercept: an overview. J Am Acad Dermatol. 2003;49(2):105–111.
   PubMed Web of Science ®Google Scholar
• Murdaca G, Gulli R, Spanò F, et al. TNF-α gene polymorphisms: association with disease susceptibility and response to anti-TNF-α treatment in psoriatic arthritis. J Invest Dermatol. 2014;134(10):25.
   Web of Science ®Google Scholar
• Kerensky TA, Gottlieb AB, Yaniv S, et al. Etanercept: efficacy and safety for approved indications. Expert Opin Drug Saf. 2012;11(1):121–139.
   PubMed Web of Science ®Google Scholar
• Tracey D, Klareskog L, Sasso EH, et al. Tumor necrosis factor antagonist mechanisms of action: a comprehensive review. Pharmacol Ther. 2008;117(2):244–279.
   PubMed Web of Science ®Google Scholar
• Tan JK, Aphale A, Malaviya R, et al. Mechanisms of action of etanercept in psoriasis. J Investig Dermatology Symp Proc. 2007;19(1):47–57.
   Google Scholar
• Tobin AM, Kirby B. TNFα inhibitors in the treatment of psoriasis and psoriatic arthritis. BioDrugs. 2005;19(1):47–57.
   PubMed Web of Science ®Google Scholar
• Enbrel: EPAR Product Information. European Medicine Agency. Available from: https://www.ema.europa.eu/en/documents/product-information/enbrel-epar-product-information_en.pdf
   Google Scholar
• Sánchez Carazo JL, Santos LM, Martinez VO. Safety of etanercept in psoriasis: a critical review. Drug Saf. 2006;29(8):675–685.
   PubMed Web of Science ®Google Scholar
• Damjanov N, Karpati S, Kemeny L, et al. Efficacy and safety of etanercept and psoriatic arthritis in the PRESTA study: analysis in patients from Central and Eastern Europe. J Dermatolog Treat. 2018 Feb;29(1):8–12.
   PubMed Web of Science ®Google Scholar
• Papp KA, Barber K, Bissonnette R, et al. A randomized, blinded assessor study to evaluate the efficacy and safety of etanercept 50 mg once weekly plus as needed topical agent vs. Etanercept 50 mg twice weekly in patients with moderate to severe plaque psoriasis (REFINE). J Eur Acad Dermatol Venereol. 2015;29(2):361–366.
   PubMed Web of Science ®Google Scholar
• Pariser DM, Leonardi CL, Gordon K, et al. Integrated safety analysis: short- and long-term safety profiles of etanercept in patients with psoriasis. J Am Acad Dermatol. 2012;67(2):245–256.
   PubMed Web of Science ®Google Scholar
• Gottlieb AB, Leonardi CL, Goffe BS, et al. Etanercept monotherapy in patients with psoriasis: a summary of safety, based on an integrated multistudy database. J Am Acad Dermatol. 2006;54(3SUPPL. 2):92–100.
   Google Scholar
• US Food and Drug administration (FDA): Silver spring, Maryland, USA. Enbrel: HIGHLIGHTS OF PRESCRIBING INFORMATION. 2015. [Internet]; 1998. p. 1–28. Available from: http://www.accessdata.fda
   Google Scholar
• FDA Guidance for industry labeling for human prescription drug and biological products – implementing the plr content and format requirements; 2013 Feb. p. 301–827. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm%0Ahttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
   Google Scholar
• Clelland S, Hunek JR. Etanercept injection site reaction. Dermatol Nurs. 2005;17(5):375.
   PubMedGoogle Scholar
• Fleischmann R, Iqbal I, Nandeshwar P, et al. Safety and efficacy of disease-modifying anti-rheumatic agents: focus on the benefits and risks of etanercept. Drug Saf. 2002;25(3):173–197.
   PubMed Web of Science ®Google Scholar
• Zeltser R, Valle L, Tanck C, et al. Clinical, histological, and immunophenotypic characteristics of injection site reactions associated with etanercept: a recombinant tumor necrosis factor α receptor: Fc fusion protein. Arch Dermatol. 2001;137(7):893–899.
   PubMed Web of Science ®Google Scholar
• Matsui T, Umetsu R, Kato Y, et al. Age-related trends in injection site reaction incidence induced by the tumor necrosis factor-α (TNF-α) inhibitors etanercept and adalimumab: the food and drug administration adverse event reporting system, 2004–2015. Int J Med Sci. 2017;14(2):102–109.
   PubMed Web of Science ®Google Scholar
• Galvão VR, Castells MC. Hypersensitivity to biological agents-updated diagnosis, management, and treatment. J Allergy Clin Immunol Pract. 2015;3(2):175–185.
   PubMed Web of Science ®Google Scholar
• Sendur OF, Turan Y, Berkit IK, et al. Angio-oedema in a patient treated with etanercept for rheumatoid arthritis. Basic Clin Pharmacol Toxicol. 2009;104(6):488–490.
   PubMed Web of Science ®Google Scholar
• Umegaki N, Kira M, Horiuchi T, et al. Etanercept is safely used for treating psoriatic arthritis in a patient complicated with type 1 hereditary angioedema. Mod Rheumatol. 2012;22(6):928–930.
   PubMed Web of Science ®Google Scholar
• Rottem M, Mader R. Successful use of etanercept in acquired angioedema in a patient with psoriatic arthritis. J Rheumatol. 2010;37(1):209.
   PubMed Web of Science ®Google Scholar
• Kimball AB, Pariser D, Yamauchi PS, et al. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013;78(5):756–764.
   Google Scholar
• Tubach F, Salmon D, Ravaud P, et al. Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: the three-year prospective French research axed on tolerance of biotherapies registry. Arthritis Rheum. 2009;60(1884):94.
   Google Scholar
• Krueger JG, Ferris LK, Menter A, et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2015;136(1):116–124.
   PubMed Web of Science ®Google Scholar
• Van Der Heijde D, Zack D, Wajdula J, et al. Rates of serious infections, opportunistic infections, inflammatory bowel disease, and malignancies in subjects receiving etanercept vs. Controls from clinical trials in ankylosing spondylitis: a pooled analysis. Scand J Rheumatol. 2014;43(1):49–53.
   PubMed Web of Science ®Google Scholar
• Downey C. Serious infection during etanercept, infliximab and adalimumab therapy for rheumatoid arthritis: a literature review. Int J Rheum Dis. 2016;19(6):536–550.
   PubMed Web of Science ®Google Scholar
• Loomba R, Liang TJ. Hepatitis B reactivation associated with immune suppressive and biological modifier therapies: current concepts, management strategies, and future directions. Gastroenterology. 2017;152(6):1297–1309.
   PubMed Web of Science ®Google Scholar
• Strangfeld A, Listing J, Herzer P, et al. Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-α agents. J Am Med Assoc. 2009;301(7):737–744.
   PubMed Web of Science ®Google Scholar
• Bardazzi F, Magnano M, Campanati A, et al. Biologic therapies in HIV-infected patients with psoriasis: an Italian experience. Acta Derm Venereol. 2017 Aug 31;97(8):989–990.
   PubMed Web of Science ®Google Scholar
• Romero-Maté A, García-Donoso C, Córdoba-Guijarro S. Efficacy and safety of etanercept in psoriasis/psoriatic arthritis: an updated review. Am J Clin Dermatol. 2007;8(3):143–155.
   PubMed Web of Science ®Google Scholar
• Chen Y, Sun J, Yang Y, et al. Malignancy risk of anti-tumor necrosis factor alpha blockers: an overview of systematic reviews and meta-analyses. Clin Rheumatol. 2016;35(1):1–18.
   PubMed Web of Science ®Google Scholar
• Dommasch ED, Abuabara K, Shin DB, et al. The risk of infection and malignancy with tumor necrosis factor antagonists in adults with psoriatic disease: a systematic review and meta-analysis of randomized controlled trials. J Am Acad Dermatol. 2011;64(6):1035–1050.
   PubMed Web of Science ®Google Scholar
• Brimhall AK, King LN, Licciardone JC, et al. Safety and efficacy of alefacept, efalizumab, etanercept and infliximab in treating moderate to severe plaque psoriasis: a meta-analysis of randomized controlled trials. Br J Dermatol. 2008;159(2):274–285.
   PubMed Web of Science ®Google Scholar
• Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008;58(5):851–864.
   PubMed Web of Science ®Google Scholar
• Bongartz T, Sutton AJ, Sweeting MJ, et al. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. J Am Med Assoc. 2006;295(19):2275–2285.
   PubMed Web of Science ®Google Scholar
• Lebrec H, Ponce R, Preston BD, et al. Tumor necrosis factor, tumor necrosis factor inhibition, and cancer risk. Curr Med Res Opin. 2015;31(3):557–574.
   PubMed Web of Science ®Google Scholar
• Sharief MK, Hentges R. Association between tumor necrosis factor-α and disease progression in patients with multiple sclerosis. N Engl J Med. 1991;325(7):467–472.
   PubMed Web of Science ®Google Scholar
• Kemanetzoglou E, Andreadou E. CNS Demyelination with TNF-α Blockers. Curr Neurol Neurosci Rep. 2017;17(4):36.
   PubMed Web of Science ®Google Scholar
• Mohan N, Edwards ET, Cupps TR, et al. Demyelination occurring during anti-tumor necrosis factor alpha therapy for. Arthritis Rheum. 2001. DOI:10.1002/1529-0131(200112)44:12<2862::AID-ART474>3.0.CO;2-W
   PubMedGoogle Scholar
• Barcellos LF, Kamdar BB, Ramsay PP, et al. Clustering of autoimmune diseases in families with a high-risk for multiple sclerosis: a descriptive study. Lancet Neurol. 2006;5(11):924–931.
   PubMed Web of Science ®Google Scholar
• Dyment DA, Sadovnick AD, Willer CJ, et al. An extended genome scan in 442 Canadian multiple sclerosis-affected sibships: a report from the Canadian collaborative study group. Hum Mol Genet. 2004;13(10):1005.
   PubMed Web of Science ®Google Scholar
• Coletta AP, Clark AL, Banarjee P, et al. Clinical trials update: RENEWAL (RENAISSANCE and RECOVER) and ATTACH. Eur J Heart Fail. 2002;4(4):459–461.
   Web of Science ®Google Scholar
• Chung ES, Packer M, Lo KH, et al. Randomized, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-α, in patients with moderate-to-severe heart failure: results of the anti-TNF therapy against congestive heart failure (ATTACH). Circulation. 2003;107(25):3133–3140.
   PubMed Web of Science ®Google Scholar
• Papp KA. The safety of etanercept for the treatment of plaque psoriasis. Ther Clin Risk Manag. 2007;3(2):245–258.
   PubMedGoogle Scholar
• Yang X, Zhu LJ, Yu XQ. Anti-TNF-α therapies in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:465898. doi: 10.1155/2010/465898.
   Google Scholar
• Watts RA. Musculoskeletal and systemic reactions to biological therapeutic agents. Curr Opin Rheumatol. 2000;12(1):49–52.
   PubMed Web of Science ®Google Scholar
• Jonsdottir T, Forslid J, Van Vollenhoven A, et al. Treatment with tumour necrosis factor α antagonists in patients with rheumatoid arthritis induces anticardiolipin antibodies. Ann Rheum Dis. 2004;73(9):1075–1078.
   Google Scholar
• Bardazzi F, Odorici G, Virdi A, et al. Autoantibodies in psoriatic patients treated with anti-TNF-α therapy. J Dtsch Dermatol Ges. 2014;12(5):401–406.
   PubMed Web of Science ®Google Scholar
• Postal M, Appenzeller S. The role of tumor necrosis factor-alpha (TNF-α) in the pathogenesis of systemic lupus erythematosus. Cytokine. 2011;56(3):537–543.
   PubMed Web of Science ®Google Scholar
• Pirowska MM, Goździalska A, Lipko-Godlewska S, et al. Original paper autoimmunogenicity during anti-TNF therapy in patients with psoriasis and psoriatic arthritis. Adv Dermatol Allergol. 2015;4:250–254.
   Google Scholar
• Pink AE, Fonia A, Allen MH, et al. Antinuclear antibodies associate with loss of response to antitumour necrosis factor-α therapy in psoriasis: a retrospective, observational study. Br J Dermatol. 2010;172(4):780–785.
   Google Scholar
• Emi Aikawa N, De Carvalho JF, Artur Almeida Silva C, et al. Immunogenicity of anti-TNF-α agents in autoimmune diseases. Clin Rev Allergy Immunol. 2010;38(2–3):82–89.
   PubMed Web of Science ®Google Scholar
• Hsu L, Snodgrass BT, Armstrong AW. Antidrug antibodies in psoriasis: a systematic review. Br J Dermatol. 2014;170(1):261–273.
   PubMedGoogle Scholar
• De Simone C, Amerio P, Amoruso G, et al. Immunogenicity of anti-TNFα therapy in psoriasis: a clinical issue? Expert Opin Biol Ther. 2013;13(12):1673–1682.
   PubMed Web of Science ®Google Scholar
• Scott LJ. Etanercept: a review of its use in autoimmune inflammatory diseases. Drugs. 2014;74(12):1379–1410.
   PubMed Web of Science ®Google Scholar
• Korzenik J, Larsen MD, Nielsen J, et al. Increased risk of developing Crohn’s disease or ulcerative colitis in 17 018 patients while under treatment with anti-TNFα agents, particularly etanercept, for autoimmune diseases other than inflammatory bowel disease. Aliment Pharmacol Ther. 2019;50(3):289–294.
   PubMed Web of Science ®Google Scholar
• O’Toole A, Lucci M, Korzenik J. inflammatory bowel disease provoked by etanercept: report of 443 possible cases combined from an IBD referral center and the FDA. Dig Dis Sci. 2016;61(6):1–3.
   PubMed Web of Science ®Google Scholar
• Whitlock SM, Enos CW, Armstrong AW, et al. Management of psoriasis in patients with inflammatory bowel disease: from the medical board of the national psoriasis foundation. J Am Acad Dermatol. 2018;78(2):383–394.
   PubMed Web of Science ®Google Scholar
• Becker H, Willeke P, Domschke W, et al. Etanercept tolerance in a patient with previous infliximab-induced hepatitis. Clin Rheumatol. 2008;27(12):1597–1598.
   PubMed Web of Science ®Google Scholar
• Research center for drug evaluation and “therapeutic biologic applications (BLA)—etanercept product approval information—licensing action 12/2/98.” WebContent. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandAppr
   Google Scholar
• Ghabril M, Bonkovsky HL, Kum C, et al. Liver injury from tumor necrosis factor-α antagonists: analysis of thirty-four cases. Clin Gastroenterol Hepatol. 2013;11(5):558–564.
   PubMed Web of Science ®Google Scholar
• Rösner S, Schad A, Kittner J, et al. Drug-induced liver injury with an autoimmune phenotype following anti-TNF therapy - Presentation of cases and review of literature. Z Gastroenterol. 2014;52(1):58–63.
   PubMed Web of Science ®Google Scholar
• Pérez-Alvarez R, Díaz-Lagares C, García-Hernández F, et al. Hepatitis B virus (HBV) reactivation in patients receiving tumor necrosis factor (TNF)-targeted therapy: analysis of 257 cases. Medicine (Baltimore). 2011;90(6):359–371.
   PubMed Web of Science ®Google Scholar
• Cassano N, Mastrandrea V, Principi M, et al. Anti-tumor necrosis factor treatment in occult hepatitis B virus infection: a retrospective analysis of 62 patients with psoriatic disease. J Biol Regul Homeost Agents. 2011;25(2):285–289.
   PubMed Web of Science ®Google Scholar
• Kim YJ, Bae SC, Sung YK, et al. Possible reactivation of potential hepatitis B virus occult infection by tumor necrosis factor-α blocker in the treatment of rheumatic diseases. J Rheumatol. 2010;37(2):346–350.
   PubMed Web of Science ®Google Scholar
• Cho YT, Chen CH, Chiu HY, et al. Use of anti-tumor necrosis factor-α therapy in hepatitis B virus carriers with psoriasis or psoriatic arthritis: a case series in Taiwan. J Dermatol. 2012;39(3):269–273.
   PubMed Web of Science ®Google Scholar
• Martinez Montiel P, Antonio Solis J, Antonio Chirinos J, et al. Hepatitis B virus reactivation during therapy with etanercept in an HBsAg-negative and anti-HBs-positive patient [2]. Liver Int. 2008;28(5):718–720.
   PubMed Web of Science ®Google Scholar
• Etanercept. In: LiverTox: clinical and research information on drug-induced liver injury [Internet] Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012. Etanercept [Updated 2017 Feb 10]. 2017.
   Google Scholar
• French JB, Bonacini M, Ghabril M, et al. Hepatotoxicity associated with the use of anti-TNF-α agents. Drug Saf. 2016;39(3):199–208.
   PubMed Web of Science ®Google Scholar
• Pescitelli L, Lazzeri L, Tripo L, et al. Safety and efficacy of HCV eradication during etanercept treatment for severe psoriasis. Dermatol Ther. 2018;31(4):e12614.
   PubMed Web of Science ®Google Scholar
• Zein NN. Etanercept as an adjuvant to interferon and ribavirin in treatment-naive patients with chronic hepatitis C virus infection: a phase 2 randomized, double-blind, placebo-controlled study. J Hepatol. 2005;42(3):315–322.
   PubMed Web of Science ®Google Scholar
• Iannone F, La Montagna G, Bagnato G, et al. Safety of etanercept and methotrexate in patients with rheumatoid arthritis and hepatitis C virus infection: a multicenter randomized clinical trial. J Rheumatol. 2014;41(2):286–292.
   PubMed Web of Science ®Google Scholar
• Teixeira LCL, Fonseca C, Sousa S, et al. Safety of etanercept in the treatment of rheumatic disease patients with Hepatitis C virus infection. Acta Reumatol Port. 2018;2018(2):159–160.
   Google Scholar
• Murdaca G, Negrini S, Pellecchio M, et al. Update upon the infection risk in patients receiving TNF alpha inhibitors. Expert Opin Drug Saf. 2019;18(3):219–229.
   PubMed Web of Science ®Google Scholar
• Brunasso AMG, Puntoni M, Gulia A, et al. Safety of anti-tumour necrosis factor agents in patients with chronic hepatitis C infection: a systematic review. Rheumatology. 2011;50(9):1700–1711.
   PubMed Web of Science ®Google Scholar
• Smith CH, Anstey AV, Barker JN, et al. British Association of Dermatologists’ guidelines for biologic interventions for psoriasis 2009. Br J Dermatol. 2009;161(5):981–1019.
   Web of Science ®Google Scholar
• Campanati A, Ganzetti G, A DS, et al. The effect of etanercept on hepatic fibrosis risk in patients with non-alcoholic fatty liver disease, metabolic syndrome, and psoriasis. J Gastroenterol. 2013;48(7):839–846.
   PubMed Web of Science ®Google Scholar
• Boetticher NC, Peine CJ, Kwo P, et al. A Randomized, Double-Blinded, Placebo-Controlled Multicenter Trial of Etanercept in the Treatment of Alcoholic Hepatitis. Gastroenterology. 2008;135(6):1956–1960.
   Web of Science ®Google Scholar
• Wu JJ, Feldman SR, Lebwohl MG. Therapy for severe psoriasis. 2016. p. 1–195.
   Google Scholar
• FDA accepts amgen’s supplemental biologics license application for the expanded use of enbrel® (etanercept) to treat pediatric patients with chronic severe plaque psoriasis. [ cited 2019 May 15]. Available from: https//amgen.com
   Google Scholar
• Paller AS, Siegfried EC, Langley RG, et al. Etanercept Treatment for Children and Adolescents with Plaque Psoriasis. N Engl J Med. 2008;358(3):241–257.
   PubMed Web of Science ®Google Scholar
• Paller AS, Siegfried EC, Pariser DM, et al. Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis. J Am Acad Dermatol. 2016;74(2):280–287.
   PubMed Web of Science ®Google Scholar
• Cline A, Bartos GJ, Strowd LC, et al. Biologic treatment options for pediatric psoriasis and atopic dermatitis. Children. 2019;6(9):103.
   Google Scholar
• Treacy G. Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFα monoclonal antibody. Hum Exp Toxicol. 2000;19(4):226–228.
   PubMed Web of Science ®Google Scholar
• Skorpen CG, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795–810.
   PubMed Web of Science ®Google Scholar
• Yiu ZZN, Griffiths CEM, Warren RB. Safety of biological therapies for psoriasis: effects on reproductive potential and outcomes in male and female patients. Br J Dermatol. 2014;171(3):485–491.
   PubMed Web of Science ®Google Scholar
• Rademaker M, Agnew K, Andrews M, et al. Psoriasis in those planning a family, pregnant or breast-feeding. The Australasian psoriasis collaboration. Australas J Dermatol. 2018;59(2):86–100.
   PubMed Web of Science ®Google Scholar
• Carter JD, Valeriano J, Vasey FB. Tumor necrosis factor-α inhibition and VATER association: a causal relationship? J Rheumatol. 2006;33(5):1014–1017.
   PubMed Web of Science ®Google Scholar
• Carter JD, Ladhani A, Ricca LR, et al. A safety assessment of tumor necrosis factor antagonists during pregnancy: a review of the food and drug administration database. J Rheumatol. 2009;36(3):635–641.
   PubMed Web of Science ®Google Scholar
• Lim LL, Fraunfelder FW, Rosenbaum JT. Do tumor necrosis factor inhibitors cause uveitis? A registry-based study. Arthritis Rheum. 2007;36(3):465–466.
   Google Scholar
• Clowse MEB. The use of anti-TNFα medications for rheumatologic disease in pregnancy. Int J Womens Health. 2010;2:199–209.
   PubMedGoogle Scholar
• Ostensen M, Eigenmann GO. Etanercept in Breast Milk. J Rheumatol. 2004;31(5):1017–1018.
   PubMed Web of Science ®Google Scholar
• Borrego L. Etanercept in pregnancy and breast-feeding. Actas Dermosifiliogr. 2010;101(1):97–101.
   PubMedGoogle Scholar
• Puchner A, Gröchenig HP, Sautner J, et al. Immunosuppressives and biologics during pregnancy and lactation: a consensus report issued by the Austrian societies of gastroenterology and hepatology and rheumatology and rehabilitation. Wien Klin Wochenschr. 2019;131(1–2):29–44.
   PubMed Web of Science ®Google Scholar
• Vaughn CJ. Drugs and Lactation Database: lactMed. J Electron Resour Med Libr. 2012;9(4):272–277.
   Google Scholar
• Gisondi P, Del Giglio M, Cotena C, et al. Combining etanercept and acitretin in the therapy of chronic plaque psoriasis: a 24-week, randomized, controlled, investigator-blinded pilot trial. Br J Dermatol. 2008;158(6):1345–1349.
   PubMed Web of Science ®Google Scholar
• Lynde CW, Gupta AK, Guenther L, et al. A randomized study comparing the combination of nbUVB and etanercept to etanercept monotherapy in patients with psoriasis who do not exhibit an excellent response after 12 weeks of etanercept. J Dermatolog Treat. 2012;23(4):261–267.
   PubMed Web of Science ®Google Scholar
• Gambichler T, Tigges C, Scola N, et al. Etanercept plus narrowband UVB phototherapy is more effective than etanercept monotherapy at 6 weeks. Br J Dermatol. 2011;164(6):1383–1386.
   PubMed Web of Science ®Google Scholar
• Farahnik B, Patel V, Beroukhim K, et al. Combining biologic and phototherapy treatments for psoriasis: safety, efficacy, and patient acceptability. Psoriasis Targets Ther. 2016;6:105–111.
   PubMedGoogle Scholar
• Lee EJ, Shin MK, Kim NI. A clinical trial of combination therapy with etanercept and low dose cyclosporine for the treatment of refractory psoriasis. Ann Dermatol. 2010;22(2):138–142.
   PubMed Web of Science ®Google Scholar
• D’Angelo S, Cutro MS, Lubrano E, et al. Combination therapy with ciclosporin and etanercept in patients with psoriatic arthritis. Ann Rheum Dis. 2010;69:934–935.
   PubMed Web of Science ®Google Scholar
• Busard C, Zweegers J, Limpens J, et al. Combined use of systemic agents for psoriasis: a systematic review. JAMA Dermatol. 2014;150(11):1213–1220.
   PubMed Web of Science ®Google Scholar
• Cuchacovich R, Garcia-Valladares I, Espinoza LR. Combination biologic treatment of refractory psoriasis and psoriatic arthritis. J Rheumatol. 2012;39(1):187–193.
   PubMed Web of Science ®Google Scholar
• Heinecke GM, Luber AJ, Levitt JO, et al. Combination use of ustekinumab with other systemic therapies: a retrospective study in a tertiary referral center. J Drugs Dermatol. 2013;12(10):1098–1102.
   PubMed Web of Science ®Google Scholar
• Babalola O, Lakdawala N, Strober BE. Combined biologic therapy for the treatment of psoriasis and psoriatic arthritis: a case report. JAAD Case Rep. 2015;1(1):3–4.
   PubMedGoogle Scholar
• Gniadecki R, Bang B, Sand C. Combination of antitumour necrosis factor-α and anti-interleukin-12/23 antibodies in refractory psoriasis and psoriatic arthritis: a long-term case-series observational study. Br J Dermatol. 2016;174(5):1145–1146.
   PubMed Web of Science ®Google Scholar
• Cather JC, Crowley JJ. Use of biologic agents in combination with other therapies for the treatment of psoriasis. Am J Clin Dermatol. 2014;15(6):467–478.
   PubMed Web of Science ®Google Scholar
• Wine-Lee L, Keller SC, Wilck MB, et al. From the medical board of the national psoriasis foundation: vaccination in adult patients on systemic therapy for psoriasis. J Am Acad Dermatol. 2013;69(6):1003–1013.
   PubMed Web of Science ®Google Scholar
• Rákóczi É, Perge B, Végh E, et al. Evaluation of the immunogenicity of the 13-valent conjugated pneumococcal vaccine in rheumatoid arthritis patients treated with etanercept. Jt Bone Spine. 2016;83(6):675–679.
   PubMed Web of Science ®Google Scholar
• Fomin I, Caspi D, Levy V, et al. Vaccination against influenza in rheumatoid arthritis: the effect of disease modifying drugs, including TNFα blockers. Ann Rheum Dis. 2006;65(2):191–194.
   PubMed Web of Science ®Google Scholar
• Papp KA, Haraoui B, Kumar D, et al. Vaccination guidelines for patients with immune-mediated disorders on immunosuppressive therapies. J Cutan Med Surg. 2018;23(1):50–74.
   PubMed Web of Science ®Google Scholar
• Furer V, Rondaan C, Heijstek MW, et al. 2019 update of EULAR recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases. Ann Rheum Dis. 2020 Jan;79(1):39-52. doi: 10.1136/annrheumdis-2019-215882.
   Google Scholar
• Gisondi P, Cazzaniga S, Chimenti S, et al. Latent tuberculosis infection in patients with chronic plaque psoriasis: evidence from the Italian Psocare Registry. Br J Dermatol. 2015;24(4):305–311.
   Google Scholar
• Amerio P, Amoruso G, Bardazzi F, et al. Detection and management of latent tuberculosis infections before biologic therapy for psoriasis. J Dermatolog Treat. 2013;172(6):1613–1620.
   Google Scholar
• Campanati A, Molinelli E, Brisigotti V, et al. biologic therapy in psoriasis (part I): efficacy and safety of tumor necrosis factor- α inhibitors. Curr Pharm Biotechnol. 2018;18(12):945–963.
   Web of Science ®Google Scholar
• Campanati A, Ganzetti G, Giuliodori K, et al. biologic therapy in psoriasis: safety profile. Curr Drug Saf. 2015;11(1):4–11.
   Web of Science ®Google Scholar
• Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as Monotherapy in Patients with Psoriasis. N Engl J Med. 2003;152(6):1304–1312.
   Google Scholar
• Gordon KB, Gottlieb AB, Leonardi CL, et al. Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy. J Dermatolog Treat. 2006;17(1):9–17.
   PubMed Web of Science ®Google Scholar