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J Am Acad Dermatol. 2019 Apr;80(4):1013-1021. doi: 10.1016/j.jaad.2018.11.059. Epub 2018 Dec 12.

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

Author information

1
Oregon Health and Science University, Portland, Oregon. Electronic address: simpsone@ohsu.edu.
2
Amgen Inc, Thousand Oaks, California.
3
MedImmune, Gaithersburg, Maryland.
4
MedImmune, Cambridge, United Kingdom.

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.

KEYWORDS:

EASI; IGA; T(H)2; biologics; biomarkers; pruritus; topical corticosteroids

PMID:
30550828
DOI:
10.1016/j.jaad.2018.11.059
[Indexed for MEDLINE]
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