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

Publication date: Available online 12 December 2018

Source: Journal of the American Academy of Dermatology

Author(s): Eric L. Simpson, Jane R. Parnes, Dewei She, Sarah Crouch, William Rees, May Mo, René van der Merwe

Abstract

Background

Tezepelumab (AMG 157/MEDI9929), a first-in-class monoclonal antibody, targets thymic stromal lymphopoietin, a cytokine implicated in atopic dermatitis (AD) pathogenesis.

Objective

Evaluate 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 Eczema Area and Severity Index (EASI50). Secondary endpoints including EASI75, Investigator's Global Assessment, Scoring of Atopic Dermatitis (SCORAD) 50, SCORAD75, pruritus numeric rating and 5-D itch scales, and exploratory endpoints (including EASI90) were assessed at Week 12, and Week 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.

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