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Tezepelumab, an anti–thymic stromal lymphopoietin monoclonal antibody, in the treatment of moderate to severe atopic dermatitis: A randomized phase 2a clinical trial - 14/03/19

Doi : 10.1016/j.jaad.2018.11.059 
Eric L. Simpson, MD a, , Jane R. Parnes, MD b, Dewei She, PhD c, Sarah Crouch, BA (Hons) d, William Rees, PhD c, May Mo, MS b, René van der Merwe, MBChB d
a Oregon Health and Science University, Portland, Oregon 
b Amgen Inc, Thousand Oaks, California 
c MedImmune, Gaithersburg, Maryland 
d MedImmune, Cambridge, United Kingdom 

Reprint requests: Eric L. Simpson, MD, Oregon and Science University, 3303 SW Bond Ave, CH16D, Portland, OR 397225.Oregon and Science University3303 SW Bond Ave, CH16DPortlandOR397225

Abstract

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.

Le texte complet de cet article est disponible en PDF.

Key words : biologics, biomarkers, EASI, IGA, pruritus, TH2, topical corticosteroids

Abbreviations used : AD, CCL17/TARC, DPP-4, EASI, IGA, IgE, IL, ITT, NRS, OR, SCORAD, SE, TCS, TEAE, TESAE, TH2, TSLP


Plan


 This study was cosponsored by MedImmune, a member of the AstraZeneca Group, and Amgen.
 Dr Simpson has received consultancy fees from AbbVie, Eli Lilly, GlaxoSmithKline, LEO Pharma, Menlo Therapeutics, Pfizer, and Regeneron Pharmaceuticals; has received fees as an advisory board member for AbbVie and Regeneron Pharmaceuticals; and has received research support for acting as a principal investigator from AbbVie, Eli Lilly, GlaxoSmithKline, Leo Pharma, Novartis, Regeneron Pharmaceuticals, Tioga, and VANDA Pharmaceuticals. Dr Parnes is an employee of Amgen Inc and owns stock and stock options in Amgen Inc. Ms Crouch is an employee of MedImmune and holds shares in AstraZeneca. Ms Mo is an employee of Amgen Inc and owns stock in Amgen Inc. Dr van der Merwe is an employee of MedImmune and hold shares in AstraZeneca.
 Drs She and Rees were employees of MedImmune at the time the study was conducted and are currently affiliated with Viela Bio, Gaithersburg.


© 2018  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 80 - N° 4

P. 1013-1021 - avril 2019 Retour au numéro
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