Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study

References

• Boguniewicz M, Alexis AF, Beck LA, et al. Expert perspectives on management of moderate-to-severe atopic dermatitis: a multidisciplinary consensus addressing current and emerging therapies. J Allergy Clin Immunol Pract. 2017;5(6):1519–1531.
   PubMed Web of Science ®Google Scholar
• Katayama I, Aihara M, Ohya Y, Japanese Society of Allergology, et al. Japanese guidelines for atopic dermatitis 2017. Allergol Int. 2017;66(2):230–247.
   PubMed Web of Science ®Google Scholar
• Wollenberg A, Barbarot S, Bieber T, 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), 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;32(6):850–878.
   PubMed Web of Science ®Google Scholar
• Sidbury R, Davis DM, Cohen DE, American Academy of Dermatology, 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
• Simpson EL, Bruin-Weller M, Flohr C, et al. When does atopic dermatitis warrant systemic therapy? Recommendations from an expert panel of the International Eczema Council. J Am Acad Dermatol. 2017;77(4):623–633.
   PubMed Web of Science ®Google Scholar
• Macdonald LE, Karow M, Stevens S, et al. Precise and in situ genetic humanization of 6 Mb of mouse immunoglobulin genes. Proc Natl Acad Sci USA. 2014;111(14):5147–5152.
   PubMed Web of Science ®Google Scholar
• Murphy AJ, Macdonald LE, Stevens S, et al. Mice with megabase humanization of their immunoglobulin genes generate antibodies as efficiently as normal mice. Proc Natl Acad Sci U S A. 2014;111(14):5153–5158.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. DUPIXENT® (dupilumab). Summary of product characteristics. [cited 2020 Dec 01]. Available from: https://ec.europa.eu/health/documents/community-register/2019/20190801145601/anx_145601_en.pdf.
   Google Scholar
• US Food and Drug Administration. DUPIXENT® (dupilumab). Highlights of prescribing information. [cited 2020 Dec 01]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s014lbl.pdf.
   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;375(24):2335–2348.
   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
• de Bruin-Weller M, Gooderham M, Cather JC, et al. Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to cyclosporine A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFÉ). Br J Dermatol. 2018;178(5):1083–1101.
   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.
   PubMed Web of Science ®Google Scholar
• Beck LA, Thaçi D, Deleuran M, et al. Dupilumab provides favorable safety and sustained efficacy for up to 3 years in an open-label study of adults with moderate-to-severe atopic dermatitis. Am J Clin Dermatol. 2020;21(4):567–577.
   PubMed 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;182(5):1120–1135.
   PubMed Web of Science ®Google Scholar
• Siegfried EC, Simpson EL, Paller AS, et al. Laboratory safety findings for dupilumab in adolescent patients with moderate-to-severe atopic dermatitis inadequately controlled by or ineligible for topical therapy. Am J Clin Dermatol. 2021; in press.
   Google Scholar
• Wollenberg A, Siegfried E, Thaçi D, et al. Laboratory safety of dupilumab in pediatric patients aged ≥6 to < 12 years with severe atopic dermatitis: results from a phase 3 trial (LIBERTY AD PEDS). Poster presented at the 29th Congress of the European Academy of Dermatology and Venereology; Virtual meeting; 29–31 October, 2020.
   Google Scholar
• U.S. Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE); version 5.0. November 27, 2017. [cited 2020 Dec 01]. Available from: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf.
   Google Scholar
• Nordic MPN Study Group. Guidelines for the diagnosis and treatment of eosinophilia. 3rd version. May 2018. [cited 2020 Dec 01]. Available from: http://www.nmpn.org./index.php/guidelines/18-care-program-for-the-diagnosis-and-treatment-of-eosinophilia-3rd-version-may-2018/file.
   Google Scholar
• Thijs J, Krastev T, Weidinger S, et al. Biomarkers for atopic dermatitis: a systematic review and meta-analysis. Curr Opin Allergy Clin Immunol. 2015;15(5):453–460.
   PubMed Web of Science ®Google Scholar
• Simpson EL, Villarreal M, Jepson B, et al. Patients with atopic dermatitis colonized with Staphylococcus aureus have a distinct phenotype and endotype. J Invest Dermatol. 2018;138(10):2224–2233.
   PubMed Web of Science ®Google Scholar
• Mukai H, Noguchi T, Kamimura K, et al. Significance of elevated serum LDH (lactate dehydrogenase) activity in atopic dermatitis. J Dermatol. 1990;17(8):477–481.
   PubMedGoogle Scholar
• Kou K, Aihara M, Matsunaga T, et al. Association of serum interleukin-18 and other biomarkers with disease severity in adults with atopic dermatitis. Arch Dermatol Res. 2012;304(4):305–312.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration 2017. JAKAFI® (ruxolitinib). Highlights of prescribing information. [cited 2020 Dec 01]. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf.
   Google Scholar
• US Food and Drug Administration 2018. XELJANZ® (tofacitinib). Highlights of prescribing information. [cited 2020 Dec 01]. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2018/203214s018lbl.pdf.
   Google Scholar
• US Food and Drug Administration 2017. OLUMIANT® (baricitinib). Highlights of prescribing information. [cited 2020 Dec 01]. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2018/207924s000lbl.pdf.
   Google Scholar