TY - JOUR
T1 - Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities
AU - Paller, Amy S
AU - Soong, Weily
AU - Boguniewicz, Mark
AU - Geng, Bob
AU - Thyssen, Jacob P
AU - Bennike, Niels
AU - Schneider, Shannon
AU - Wollenberg, Andreas
N1 - Copyright © 2025. Published by Elsevier Inc.
PY - 2025/10
Y1 - 2025/10
N2 - BACKGROUND: Atopic dermatitis (AD) is known to be associated with other atopic comorbidities that all involve type 2 immune dysregulation. Tralokinumab is a monoclonal antibody that specifically targets interleukin-13. As comorbid atopic disease could indicate a more severe AD phenotype, it is important to assess the effect of tralokinumab treatment in patients with these comorbidities.OBJECTIVE: To assess the efficacy and safety of tralokinumab treatment for AD in adult and adolescent patients with moderate-to-severe AD with and without a patient-reported history of atopic comorbidities at baseline, using data from the placebo-controlled trials (ECZema TRAlokinumab) ECZTRA 1, ECZTRA 2, ECZTRA 3, and ECZTRA 6.METHODS: In this post hoc analysis, subgroups were defined by a history of patient-reported asthma, food allergy, hay fever, and/or allergic conjunctivitis. End points included greater than or equal to 75% improvement in Eczema Area and Severity Index-75, Investigator's Global Assessment score of 0 or 1, and adverse events at week 16.RESULTS: At baseline, patients with a history of at least 1 atopic comorbidity exhibited more severe disease than patients with no atopic comorbidities. At week 16, higher proportions of adult and adolescent patients receiving tralokinumab vs placebo achieved Eczema Area and Severity Index-75 and Investigator's Global Assessment score of 0 or 1, regardless of the presence of atopic comorbidities at baseline. Most adverse events were of mild or moderate severity.CONCLUSION: Regardless of the presence or number of self-reported atopic comorbidities, 16 weeks of tralokinumab treatment improved AD severity in adults and adolescents.TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: ECZTRA 1 (NCT03131648); ECZTRA 2 (NCT03160885); ECZTRA 3 (NCT03363854); and ECZTRA 6 (NCT03526861).
AB - BACKGROUND: Atopic dermatitis (AD) is known to be associated with other atopic comorbidities that all involve type 2 immune dysregulation. Tralokinumab is a monoclonal antibody that specifically targets interleukin-13. As comorbid atopic disease could indicate a more severe AD phenotype, it is important to assess the effect of tralokinumab treatment in patients with these comorbidities.OBJECTIVE: To assess the efficacy and safety of tralokinumab treatment for AD in adult and adolescent patients with moderate-to-severe AD with and without a patient-reported history of atopic comorbidities at baseline, using data from the placebo-controlled trials (ECZema TRAlokinumab) ECZTRA 1, ECZTRA 2, ECZTRA 3, and ECZTRA 6.METHODS: In this post hoc analysis, subgroups were defined by a history of patient-reported asthma, food allergy, hay fever, and/or allergic conjunctivitis. End points included greater than or equal to 75% improvement in Eczema Area and Severity Index-75, Investigator's Global Assessment score of 0 or 1, and adverse events at week 16.RESULTS: At baseline, patients with a history of at least 1 atopic comorbidity exhibited more severe disease than patients with no atopic comorbidities. At week 16, higher proportions of adult and adolescent patients receiving tralokinumab vs placebo achieved Eczema Area and Severity Index-75 and Investigator's Global Assessment score of 0 or 1, regardless of the presence of atopic comorbidities at baseline. Most adverse events were of mild or moderate severity.CONCLUSION: Regardless of the presence or number of self-reported atopic comorbidities, 16 weeks of tralokinumab treatment improved AD severity in adults and adolescents.TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: ECZTRA 1 (NCT03131648); ECZTRA 2 (NCT03160885); ECZTRA 3 (NCT03363854); and ECZTRA 6 (NCT03526861).
KW - Adolescent
KW - Adult
KW - Antibodies, Monoclonal/therapeutic use
KW - Asthma/epidemiology
KW - Comorbidity
KW - Conjunctivitis, Allergic/epidemiology
KW - Dermatitis, Atopic/drug therapy
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Interleukin-13/antagonists & inhibitors
KW - Male
KW - Middle Aged
KW - Severity of Illness Index
KW - Treatment Outcome
KW - Young Adult
UR - http://www.scopus.com/inward/record.url?scp=105011091226&partnerID=8YFLogxK
U2 - 10.1016/j.anai.2025.06.022
DO - 10.1016/j.anai.2025.06.022
M3 - Journal article
C2 - 40555305
SN - 1081-1206
VL - 135
SP - 425-433.e4
JO - Annals of Allergy, Asthma, & Immunology
JF - Annals of Allergy, Asthma, & Immunology
IS - 4
ER -