Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb
| Autor: | Andreas Wollenberg, Koustubh Ranade, Jonathan I. Silverberg, Rachel Moate, Emma Guttman-Yassky, Michael D. Howell, René van der Merwe, Christopher Kell |
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| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Administration Topical Injections Subcutaneous Immunology Placebo Eczema Area and Severity Index Dermatitis Atopic 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Immunology and Allergy Humans SCORAD Adverse effect Glucocorticoids Interleukin-13 medicine.diagnostic_test business.industry Antibodies Monoclonal Dermatology Life Quality Index Atopic dermatitis Middle Aged medicine.disease 030104 developmental biology Tolerability Female business Tralokinumab |
| Zdroj: | The Journal of allergy and clinical immunology. 143(1) |
| ISSN: | 1097-6825 |
| Popis: | Background IL-13 has an important role in atopic dermatitis (AD) pathogenesis. Tralokinumab is a fully human mAb that potently and specifically neutralizes IL-13. Objective We sought to evaluate the efficacy and safety of tralokinumab in adults with moderate-to-severe AD. Methods In this phase 2b study (NCT02347176), 204 adults were randomized 1:1:1:1 to receive 45, 150, or 300 mg of subcutaneous tralokinumab, or placebo, every 2 weeks for 12 weeks with concomitant topical glucocorticoids. Coprimary end points were change from baseline in Eczema Area Severity Index score and percentage of participants with an Investigator's Global Assessment response (0/1 score and reduction of ≥2 grades from baseline) at week 12. Results At week 12, 300 mg of tralokinumab significantly improved change from baseline in Eczema Area Severity Index score versus placebo (adjusted mean difference, −4.94; 95% CI, −8.76 to −1.13; P = .01), and a greater percentage of participants achieved an Investigator's Global Assessment response (26.7% vs 11.8%). Greater responses were found in participants with greater concentrations of biomarkers of increased IL-13 activity. Participants treated with 300 mg of tralokinumab demonstrated improvements in SCORAD, Dermatology Life Quality Index, and pruritus numeric rating scale (7-day mean) scores versus placebo. Upper respiratory tract infection was the most frequent treatment-emergent adverse event reported as related to study drug in the placebo (3.9%) and pooled tralokinumab (3.9%) groups. Conclusions Tralokinumab treatment was associated with early and sustained improvements in AD symptoms and an acceptable safety and tolerability profile, thereby providing evidence for targeting IL-13 in patients with AD. |
| Databáze: | OpenAIRE |
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