TY - JOUR
T1 - Tezepelumab, an anti–thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis
T2 - A randomized phase 2a clinical trial
AU - Simpson, Eric L.
AU - Parnes, Jane R.
AU - She, Dewei
AU - Crouch, Sarah
AU - Rees, William
AU - Mo, May
AU - van der Merwe, René
N1 - Publisher Copyright:
© 2018 American Academy of Dermatology, Inc.
PY - 2019/4
Y1 - 2019/4
N2 - Background: Tezepelumab (AMG 157/MEDI9929), a first-in-class monoclonal antibody, targets thymic stromal lymphopoietin, a cytokine that is implicated in the pathogenesis of atopic dermatitis (AD). Objective: We sought to evaluate the efficacy and safety of tezepelumab in adults with moderate to severe AD. Methods: In this phase 2a study (NCT02525094), 113 patients were randomized 1:1 to subcutaneous tezepelumab 280 mg or placebo every 2 weeks, plus class 3 topical corticosteroids (TCS). The primary endpoint was the week 12 response rate for a ≥50% reduction in the Eczema Area and Severity Index (EASI50). Secondary endpoints including EASI75, Investigator's Global Assessment, SCORAD 50, SCORAD 75, pruritus numeric rating and 5-D itch scales, and exploratory endpoints (including EASI90) were assessed at weeks 12, and 16 (post hoc). Results: A numerically greater percentage of tezepelumab plus TCS-treated patients achieved EASI50 (64.7%) versus placebo plus TCS (48.2%; P =.091). Numerical improvements over placebo were demonstrated for week 12 secondary and exploratory endpoints, with further improvements at week 16. Treatment-emergent adverse events were similar between treatment groups. Limitations: Greater than expected response rates in placebo-treated patients were possibly attributable to TCS. Conclusion: Although not statistically significant, numerical improvements over placebo for all week 12 endpoints were demonstrated, with greater week 16 responses.
AB - Background: Tezepelumab (AMG 157/MEDI9929), a first-in-class monoclonal antibody, targets thymic stromal lymphopoietin, a cytokine that is implicated in the pathogenesis of atopic dermatitis (AD). Objective: We sought to evaluate the efficacy and safety of tezepelumab in adults with moderate to severe AD. Methods: In this phase 2a study (NCT02525094), 113 patients were randomized 1:1 to subcutaneous tezepelumab 280 mg or placebo every 2 weeks, plus class 3 topical corticosteroids (TCS). The primary endpoint was the week 12 response rate for a ≥50% reduction in the Eczema Area and Severity Index (EASI50). Secondary endpoints including EASI75, Investigator's Global Assessment, SCORAD 50, SCORAD 75, pruritus numeric rating and 5-D itch scales, and exploratory endpoints (including EASI90) were assessed at weeks 12, and 16 (post hoc). Results: A numerically greater percentage of tezepelumab plus TCS-treated patients achieved EASI50 (64.7%) versus placebo plus TCS (48.2%; P =.091). Numerical improvements over placebo were demonstrated for week 12 secondary and exploratory endpoints, with further improvements at week 16. Treatment-emergent adverse events were similar between treatment groups. Limitations: Greater than expected response rates in placebo-treated patients were possibly attributable to TCS. Conclusion: Although not statistically significant, numerical improvements over placebo for all week 12 endpoints were demonstrated, with greater week 16 responses.
KW - EASI
KW - IGA
KW - T 2
KW - biologics
KW - biomarkers
KW - pruritus
KW - topical corticosteroids
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U2 - 10.1016/j.jaad.2018.11.059
DO - 10.1016/j.jaad.2018.11.059
M3 - Article
C2 - 30550828
AN - SCOPUS:85061431990
SN - 0190-9622
VL - 80
SP - 1013
EP - 1021
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 4
ER -