Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis

Key Points Question What is the efficacy and safety of lebrikizumab in combination with background topical corticosteroid (TCS) therapy in adolescents and adults with moderate-to-severe atopic dermatitis (AD)? Findings In a randomized, placebo-controlled, phase 3 clinical trial studying 211 patients (adolescents and adults) with moderate-to-severe AD, lebrikizumab was associated with improved physician-reported signs of AD and patient-reported outcomes of pruritus and quality of life compared with TCS alone, over 16 weeks of treatment. Meaning Lebrikizumab, a monoclonal antibody inhibiting interleukin-13, combined with TCS was associated with reduced overall disease severity of moderate-to-severe AD in adolescents and adults, and had a safety profile consistent with previous lebrikizumab AD studies.

[1]  S. Heegaard,et al.  IL‐4 and IL‐13 both contribute to the homeostasis of human conjunctival goblet cells in vitro , 2022, Allergy.

[2]  C. Flohr,et al.  Systemic Immunomodulatory Treatments for Atopic Dermatitis , 2022, JAMA dermatology.

[3]  M. Worm,et al.  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) * , 2021, The British journal of dermatology.

[4]  K. Drerup,et al.  A new era has begun: Treatment of atopic dermatitis with biologics , 2021, Allergologie select.

[5]  S. Shumack,et al.  Treat-to-Target in Atopic Dermatitis: An International Consensus on a Set of Core Decision Points for Systemic Therapies , 2021, Acta dermato-venereologica.

[6]  S. Langan,et al.  Atopic dermatitis , 2020, The Lancet.

[7]  A. Armstrong,et al.  Efficacy and Safety of Lebrikizumab, a High-Affinity Interleukin 13 Inhibitor, in Adults With Moderate to Severe Atopic Dermatitis , 2020, JAMA dermatology.

[8]  T. Bieber.  Interleukin‐13: Targeting an underestimated cytokine in atopic dermatitis , 2020, Allergy.

[9]  James T. Elder,et al.  Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. , 2019, The Journal of investigative dermatology.

[10]  M. Moyle,et al.  Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches , 2019, Experimental dermatology.

[11]  W. Liao,et al.  A review of dupilumab in the treatment of atopic diseases , 2019, Human vaccines & immunotherapeutics.

[12]  J. Krueger,et al.  Atopic dermatitis endotypes and implications for targeted therapeutics. , 2019, The Journal of allergy and clinical immunology.

[13]  J. Silverberg,et al.  Epidemiology of adult atopic dermatitis. , 2018, Clinics in dermatology.

[14]  D. Margolis,et al.  Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. , 2018, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[15]  A. Muraro,et al.  Consensus‐based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part II , 2018, Journal of the European Academy of Dermatology and Venereology : JEADV.

[16]  A. Muraro,et al.  Consensus‐based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I , 2018, Journal of the European Academy of Dermatology and Venereology : JEADV.

[17]  C. Flohr,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) , 2018, Journal of the American Academy of Dermatology.

[18]  J. Silverberg,et al.  Burden of skin pain in atopic dermatitis. , 2017, Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology.

[19]  G. Yancopoulos,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 , 2017, The Lancet.

[20]  L. Naldi,et al.  Prevalence of contact allergy in the general population in different European regions , 2016, The British journal of dermatology.

[21]  P. Polgreen,et al.  Opportunistic infections and biologic therapies in immune-mediated inflammatory diseases: consensus recommendations for infection reporting during clinical trials and postmarketing surveillance , 2015, Annals of the rheumatic diseases.

[22]  S. Feldman,et al.  Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents. , 2014, Journal of the American Academy of Dermatology.

[23]  S. Feldman,et al.  Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. , 2014, Journal of the American Academy of Dermatology.

[24]  Christiane,et al.  World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. , 2013, JAMA.

[25]  A. Pession,et al.  Atopic dermatitis in adolescence , 2011, Dermatology reports.

[26]  Alexandru D. P. Papoiu,et al.  What causes itch in atopic dermatitis? , 2008, Current allergy and asthma reports.

[27]  D. Gíslason,et al.  Eczema, atopy and allergen exposure in adults: a population‐based study , 2007, Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology.

[28]  H. Fujita,et al.  Prevalence of atopic dermatitis determined by clinical examination in Japanese adults , 2006, The Journal of dermatology.