THE EFFICACY AND SAFETY OF LEBRIKIZUMAB PLUS TOPICAL CORTICOSTEDOIDS IN MODERATETO SEVERE ATOPIC DERMATITIS.
DOI:
https://doi.org/10.48047/vwmbcr61Keywords:
Atopic dermatitis, lebrikizumab, topical corticosteroids, phase 3 trial, EASI-75Abstract
Inflammatory and chronic skin conditions such as AD have a serious impact on patients' quality of life. A phase 3 randomised, placebo-controlled trial, ADhere (NCT04250337) examined the efficacy and safety of low-to-mid potency topical corticosteroids (TCSs) that contain IL-13 monoclonal antibody in moderate and severe AD, adolescents, and adults. Combining lebrikizumab and TCS was found to have tremendous effects on skin clearance and itch intensity, sleep disturbances, and quality of life in the trial. There has already been a statistically significant increase in EASI-75 week 4 and IGA (0,1) week 8 responses. Combination therapy was highly compliant and mild or moderate adverse events were reported mainly. In addition, these findings support the use of lebrikizumab and TCS as an effective method of managing moderate and severe AD.
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Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020;396(10247):345–360.
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.
Diepgen TL, Ofenloch RF, Bruze M, et al. Prevalence of contact allergy in the general population in different European regions. Br J Dermatol. 2016;174(2):319–329.
Sacotte R, Silverberg JI. Epidemiology of adult atopic dermatitis. Clin Dermatol. 2018;36(5):595–605.
Saeki H, Tsunemi Y, Fujita H, et al. Prevalence of atopic dermatitis determined by clinical examination in Japanese adults. J Dermatol. 2006;33(11):817–819.
Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Curr Allergy Asthma Rep. 2008;8(4):306–311.
Silverberg JI, Gelfand JM, Margolis DJ, et al. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018;121(3):340–347.
Vakharia PP, Chopra R, Sacotte R, et al. Burden of skin pain in atopic dermatitis. Ann Allergy Asthma Immunol. 2017;119(6):548–552.e3.
Ricci G, Bellini F, Dondi A, Patrizi A, Pession A. Atopic dermatitis in adolescence. Dermatol Reports. 2011;4(1):e1.
Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338–351.
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.
Thibodeaux Q, Smith MP, Ly K, Beck K, Liao W, Bhutani T. A review of dupilumab in the treatment of atopic diseases. Hum Vaccin Immunother. 2019;15(9):2129–2139.
Stölzl D, Weidinger S, Drerup K. A new era has begun: Treatment of atopic dermatitis with biologics. Allergol Select. 2021;5:265–273.
Drucker AM, Morra DE, Prieto-Merino D, et al. Systemic immunomodulatory treatments for atopic dermatitis: update of a living systematic review and network meta-analysis. 2022;158(5):523–532.
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 I. J Eur Acad Dermatol Venereol. 2018;32(5):657–682.
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.
Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54–62.
Moyle M, Cevikbas F, Harden JL, Guttman-Yassky E. Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756–768.
Tsoi LC, Rodriguez E, Degenhardt F, et al. Atopic dermatitis is an IL-13-dominant disease with greater molecular heterogeneity compared to psoriasis. J Invest Dermatol. 2019;139(7):1480–1489.
Okragly A, Ryuzoji A, Daniels M, Patel C, Benschop R. Comparison of the affinity and in vitro activity of lebrikizumab, tralokinumab, and cendakimab. Paper presented at: Inflammatory Skin Disease Summit. November 06, 2021; New York, New York.
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;156(4):411–420.
Silverberg JI, Thaçi D, Seneschal J, et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: results from two phase 3, randomized, double-blinded, placebo-controlled trials. Paper presented at: American Academy of Dermatology; 2022; Boston, MA.
Pillai S, Thaci D, Guttman-Yassky E, Simpson E, Blauvelt A, et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: results from two phase 3, randomized, double-blinded, placebo-controlled trials. American Academy of Dermatology – 80th Annual Meeting. March 26, 2022; Boston, Massachusetts.
Czarnowicki T, He H, Krueger JG, Guttman-Yassky E. Atopic dermatitis endotypes and implications for targeted therapeutics. J Allergy Clin Immunol. 2019;143(1):1–11.
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–2194.
Winthrop KL, Novosad SA, Baddley JW, et al. Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance. Ann Rheum Dis. 2015;74(12):2107–2116.
De Bruin-Weller M, Biedermann T, Bissonnette R, et al. Treat-to-target in atopic dermatitis: an international consensus on a set of core decision points for systemic therapies. Acta Derm Venereol. 2021;101(2):adv00402.
Simpson EL, Flohr C, Eichenfield LF, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: a randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018;78(5):863–871.e11.
ClinicalTrials.gov. A study to evaluate the safety of lebrikizumab compared to topical corticosteroids in adult patients with atopic dermatitis. Accessed May 6, 2022.
Hansen PM, Tollenaere MAX, Hedengran A, et al. IL-4 and IL-13 both contribute to the homeostasis of human conjunctival goblet cells in vitro. Allergy. 2022;77(8):2555–2558.
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, randomized, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287–2303.
Gutermuth J, Pink AE, Worm M, Soldbro L, Bjerregård Øland C, Weidinger S. Tralokinumab plus topical corticosteroids in adults with severe atopic dermatitis and inadequate response to or intolerance of ciclosporin A: a placebo-controlled, randomized, phase III clinical trial (ECZTRA 7). Br J Dermatol. 2022;186(3):440–452.
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