Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2025
Effect of tralokinumab on moderate-to-severe atopic dermatitis in patients with atopic comorbidities.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Paller Amy S, Soong Weily, Boguniewicz Mark, Geng Bob, Thyssen Jacob P, Bennike Niels, Schneider Shannon, Wollenberg Andreas
Аннотация
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).
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).