Effectiveness and Safety of Tralokinumab in Atopic Dermatitis: 1-year Results From a Real-world Multicentre Study

Authors

  • Laura Calabrese Dermatology Unit, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy; Institute of Dermatology, Catholic University of the Sacred Heart, Rome, Italy
  • Elisa Cinotti Dermatology Unit, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy
  • Martina D’Onghia Dermatology Unit, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy
  • Alessandra Cartocci Dermatology Unit, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy
  • Pietro Rubegni Dermatology Unit, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy
  • François Maccari Cabinet médical, Saint-Maur-des-Fossés, France; Department of Dermatology, Hôpital d’Instruction des Armées Begin, Saint Mandé, France
  • Claire Boulard Department of Dermatology, Centre Hospitalier du Havre, Le Havre, France
  • Ziad Reguiai Department of Dermatology, Polyclinique Courlancy, Reims-Bezannes, France
  • Pierre-André Becherel Dermatology and clinical Immunology unit, Antony Hospital, Antony, France
  • Caroline Jacobzone Department of Dermatology, Centre Hospitalier Bretagne Sud, Lorient, France
  • Edouard Begon Department of Dermatology, Centre Hospitalier René Dubos, Pontoise, France
  • Charlotte Fite Department of Dermatology, Hôpital Saint Joseph, Paris, France
  • Beatrice Walls Department of Dermatology, Hôpital Saint Joseph, Paris, France
  • Anne Laure Liegeon Department of Dermatology, Centre Hospitalier regional Metz-Thionville, Thionville, France
  • Josiane Parier Cabinet médical, Saint-Maur-des-Fossés, France
  • Guillaume Chaby Department of Dermatology, CHU Amiens-Picardie, Amiens, France
  • Jean-Luc Perrot Department of Dermatology, CHU Saint Etienne, Saint Etienne, France

DOI:

https://doi.org/10.2340/actadv.v105.42275

Keywords:

Tralokinumab, antibodies, monoclonal, clinical effectiveness, patient-relevant outcomes, atopic dermatitis

Abstract

Tralokinumab is a monoclonal antibody selectively targeting IL-13, approved for moderate-to-severe atopic dermatitis (AD), for which real-world data are scarce. This prospective, observational, multicentric study aimed to assess the long-term effectiveness and safety of tralokinumab in patients with AD in a real-world setting. Primary outcomes included 50%, 75%, and 90% improvement in Eczema Area and Severity Index score (EASI50, EASI75, EASI90, respectively) and improvements in Dermatology Life Quality Index (DLQI) at 1 year. A total of 136 patients with AD were enrolled in the study; data at 1-year follow-up were available for 111 patients. After 1 year, 68.5% and 33.3% of patients achieved an EASI75 and EASI90, respectively. A significantly higher percentage of patients with than without foot involvement achieved EASI50 (p = 0.009) and EASI75 (p = 0.022). Similarly, hand involvement was significantly associated with higher EASI50 response (p = 0.005). Median DLQI score decreased from 9.00 (interquartile range (IQR): 6.00, 13.75) to 1.00 (IQR: 0.00, 4.00) after 1 year of treatment. Adverse events included blepharitis (n = 10), conjunctivitis (n = 6), and injection-site reactions (n = 2). Tralokinumab can be an effective and safe treatment for patients with moderate-to-severe AD. Involvement of certain body areas, such as hands and feet, might positively predict a clinical response to tralokinumab.

Downloads

Download data is not yet available.

References

Silverberg JI. Public health burden and epidemiology of atopic dermatitis. Dermatol Clin 2017; 35: 283–289.

https://doi.org/10.1016/j.det.2017.02.002 DOI: https://doi.org/10.1016/j.det.2017.02.002

Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet 2020; 396: 345–360.

https://doi.org/10.1016/S0140-6736(20)31286-1 DOI: https://doi.org/10.1016/S0140-6736(20)31286-1

Chiricozzi A, Maurelli M, Calabrese L, Perris K, Girolomoni G. Overview of atopic dermatitis in different ethnic groups. J Clin Med 2023; 12: 2701.

https://doi.org/10.3390/jcm12072701 DOI: https://doi.org/10.3390/jcm12072701

Silverberg NB. Typical and atypical clinical appearance of atopic dermatitis. Clin Dermatol 2017; 35: 354–359.

https://doi.org/10.1016/j.clindermatol.2017.03.007 DOI: https://doi.org/10.1016/j.clindermatol.2017.03.007

Ali F, Vyas J, Finlay AY. Counting the burden: atopic dermatitis and health-related quality of life. Acta Derm Venereol 2020; 100: adv00161.

https://doi.org/10.2340/00015555-3511 DOI: https://doi.org/10.2340/00015555-3511

Silverberg JI, Gelfand JM, Margolis DJ, Boguniewicz M, Fonacier L, Grayson MH, 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: 340–347.

https://doi.org/10.1016/j.anai.2018.07.006 DOI: https://doi.org/10.1016/j.anai.2018.07.006

Drucker AM, Wang AR, Qureshi AA. Research gaps in quality of life and economic burden of atopic dermatitis: the National Eczema Association Burden of Disease Audit. JAMA Dermatol 2016; 152: 873–874.

https://doi.org/10.1001/jamadermatol.2016.1978 DOI: https://doi.org/10.1001/jamadermatol.2016.1978

European Medicines Agency. Dupilumab (Dupixent): summary of product characteristics; 2017. [accessed March 9, 2024] Available from: https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf

Faiz S, Giovannelli J, Podevin C, Jachiet M, Bouaziz J-D, Reguiai Z, et al. Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort. J Am Acad Dermatol 2019; 81: 143–151.

https://doi.org/10.1016/j.jaad.2019.02.053 DOI: https://doi.org/10.1016/j.jaad.2019.02.053

Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med 2016; 375: 2335–2348.

https://doi.org/10.1056/NEJMoa1610020 DOI: https://doi.org/10.1056/NEJMoa1610020

European Medicines Agency. Tralokinumab (Adtralza): summary of product characteristics; 2021. [accessed January 28, 2024] Available from: https://www.ema.europa.eu/en/documents/product-information/adtralza-epar-product-information_en.pdf

Silverberg JI, Toth D, Bieber T, Alexis AF, Elewski BE, Pink AE, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol 2021; 184: 450–463.

https://doi.org/10.1111/bjd.19573 DOI: https://doi.org/10.1111/bjd.19573

Gutermuth J, Pink AE, Worm M, Soldbro M, Bjerregård Øland C, Weidinger S, 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). Br J Dermatol 2022; 186: 440–452.

https://doi.org/10.1111/bjd.20832 DOI: https://doi.org/10.1111/bjd.20832

Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour J-P, et al. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol 2021; 184: 437–449.

https://doi.org/10.1111/bjd.19574 DOI: https://doi.org/10.1111/bjd.19574

Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol 2001; 10: 11–18.

https://doi.org/10.1034/j.1600-0625.2001.100102.x DOI: https://doi.org/10.1034/j.1600-0625.2001.100102.x

Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol 2008; 159: 997–1035.

https://doi.org/10.1111/j.1365-2133.2008.08832.x DOI: https://doi.org/10.1111/j.1365-2133.2008.08832.x

Jenkinson C, Layte R. Development and testing of the UK SF-12 (short form health survey). J Health Serv Res Policy 1997; 2: 14–18.

https://doi.org/10.1177/135581969700200105 DOI: https://doi.org/10.1177/135581969700200105

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220–233.

https://doi.org/10.1097/00005650-199603000-00003 DOI: https://doi.org/10.1097/00005650-199603000-00003

Food and Drug Administration. Tralokinumab (Adtralza): summary of product characteristics; 2017. [accessed January 28, 2024] Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf

Pezzolo E, Naldi L. Tralokinumab in the treatment of resistant atopic dermatitis: an open-label, retrospective case series study. J Eur Acad Dermatol Venereol 2023; 37: e644–e645.

https://doi.org/10.1111/jdv.18753 DOI: https://doi.org/10.1111/jdv.18753

Schlosser AR, Shareef M, Olydam J, Nijsten TEC, Jan Hijnen D. Tralokinumab treatment for patients with moderate-to-severe atopic dermatitis in daily practice. Clin Exp Dermatol 2023; 48: 510–517.

https://doi.org/10.1093/ced/llad038 DOI: https://doi.org/10.1093/ced/llad038

De Greef A, Ghislain PD, Bulinckx A, Coster A, de Halleux C, Damsin T, et al. Real-life experience of tralokinumab for the treatment of adult patients with severe atopic dermatitis: a multicentric prospective study. Clin Drug Investig 2023; 43: 299–306.

https://doi.org/10.1007/s40261-023-01258-7 DOI: https://doi.org/10.1007/s40261-023-01258-7

Gargiulo L, Ibba L, Vignoli CA, Facheris P, Valenti M, Constanzo A, et al. Tralokinumab rapidly improves subjective symptoms and quality of life in patients with moderate-to-severe atopic dermatitis: a real-life 16-week experience. J Dermatolog Treat 2023; 34: 2216815.

https://doi.org/10.1080/09546634.2023.2216815 DOI: https://doi.org/10.1080/09546634.2023.2216815

Pezzolo E, Schena D, Gambardella A, Rossi M, Barei F, Calzavara Pinton P, et al. Survival, efficacy and safety of tralokinumab after 32 and 52 weeks of treatment for moderate-to-severe atopic dermatitis in adults: a multicentre real-world study. J Eur Acad Dermatol Venereol 2024; 38: e11–e13.

https://doi.org/10.1111/jdv.19382 DOI: https://doi.org/10.1111/jdv.19382

García Castro R, Heras Mendaza F, Santiago Sánchez-Mateos DI, Fariña Sabrí MC, Alcaraz Leon I. First short-term effectiveness and security data of tralokinumab in severe atopic dermatitis in real clinical practice. Dermatitis 2024; 35: 301–303.

https://doi.org/10.1089/derm.2023.0030 DOI: https://doi.org/10.1089/derm.2023.0030

Pereyra-Rodriguez JJ, Herranz P, Ruiz-Villaverde R, Elosua-Gonzáles M, Galán Gutiérrez M, Figuerus-Nart I, et al. Treatment of severe atopic dermatitis with tralokinumab in clinical practice: short-term effectiveness and safety results. Clin Exp Dermatol 2023; 48: 991–997.

https://doi.org/10.1093/ced/llad153 DOI: https://doi.org/10.1093/ced/llad153

Chiricozzi A, Ferrucci SM, Di Nardo L, Gori N, Balato A, Ortoncelli M, et al. Current treatment goals are achieved by the majority of patients with atopic dermatitis treated with tralokinumab: results from a multicentric, multinational, retrospective, cohort study. Expert Opin Biol Ther 2023; 23: 1307–1315.

https://doi.org/10.1080/14712598.2023.2292627 DOI: https://doi.org/10.1080/14712598.2023.2292627

Vittrup I, Krogh NS, Larsen HHP, Elberling J, Skov L, Ibler KS, et al. A nationwide 104 weeks real-world study of dupilumab in adults with atopic dermatitis: ineffectiveness in head-and-neck dermatitis. J Eur Acad Dermatol Venereol 2023; 37: 1046–1055.

https://doi.org/10.1111/jdv.18849 DOI: https://doi.org/10.1111/jdv.18849

Paolino G, Narcisi A, Carugno A, Malagoli P, Di Nicola MR, Foti R, et al. Successful use of tralokinumab for the treatment of atopic dermatitis on the genitals. J Dermatolog Treat 2024; 35: 2351489.

https://doi.org/10.1080/09546634.2024.2351489 DOI: https://doi.org/10.1080/09546634.2024.2351489

Gori N, Ippoliti E, Ferrucci SM, Balato A, Ortoncelli M, Maurelli M, et al. Successful response to tralokinumab in patients unresponsive, intolerant or with contraindications to dupilumab and JAK inhibitors: a case series. J Eur Acad Dermatol Venereol 2024; 38: e852–854.

https://doi.org/10.1111/jdv.19929 DOI: https://doi.org/10.1111/jdv.19929

Additional Files

Published

2025-03-12

How to Cite

Calabrese, L., Cinotti, E., D’Onghia, M., Cartocci, A., Rubegni, P., Maccari , F., … Perrot, J.-L. (2025). Effectiveness and Safety of Tralokinumab in Atopic Dermatitis: 1-year Results From a Real-world Multicentre Study. Acta Dermato-Venereologica, 105, adv42275. https://doi.org/10.2340/actadv.v105.42275

Issue

Section

Articles

Categories