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Drug Profile

A critical evaluation of suitability of tralokinumab for treatment of moderate-to-severe atopic dermatitis in adolescents and adults

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Pages 255-266 | Received 21 Aug 2023, Accepted 10 Nov 2023, Published online: 27 Nov 2023
 

ABSTRACT

Introduction

Atopic dermatitis (AD) is a chronic, intensely pruritic disease associated with significant patient burden. Recent advancements in AD pathogenesis have expanded its therapeutics pipeline. Tralokinumab is a fully human monoclonal antibody that binds specifically Interleukin (IL)-13, inhibiting the downstream IL-13 signaling. Phase 3 clinical trials and some real-world studies showed that tralokinumab, as monotherapy or in combination with topical corticosteroids, is efficacious and safe in adult patients with moderate-to-severe AD. Similar results were reported in a phase 3 trial in adolescents (aged ≥12 years).

Areas covered

We review the role of IL-13 in AD and discuss the value of tralokinumab for treating moderate-to-severe AD, comparing efficacy and safety results derived from clinical trials and real-life data.

Expert opinion

The role of IL-13 in AD supports a targeted therapeutic approach. Tralokinumab has proven efficacious and well-tolerated in a large proportion of patients confirming its value for treating moderate-to-severe AD from age 12 years onwards; it quickly improves itching and can maintain a high-level of response over time; it can be administered with flexible dosing schedules. Future studies will further clarify the role of IL-13 pathway and which patients would be best suited to tralokinumab, shifting AD treatment into an era of precision medicine.

Article highlights

  • IL-13 is a driver cytokine in AD, contributing to barrier dysfunction and skin dysbiosis. It induces itch and plays a homeostatic role in maintaining filled goblet cells in the conjunctiva.

  • Tralokinumab, whether used as monotherapy or in combination with topical corticosteroids, has proven to be efficacious and well-tolerated for treating moderate-to-severe AD across all patient age groups, from adolescence onward. It offers a sustained therapeutic response in a significant proportion of patients and can be administered with flexibility in dosage.

  • Future studies will undoubtedly contribute to the evolving understanding of AD pathogenesis, particularly in terms of the IL-13 pathway’s role. This will enable a more precise selection of patients who are optimally suited for tralokinumab treatment, ushering in an era of precision medicine.

Declaration of interest

E Pezzolo has been consultant and speaker for Sanofi Genzyme, Leo Pharma, Novartis, and is a speaker for Sanofi Genzyme and Leo Pharma. L Naldi has been consultant and speaker for Abbie, Almirall, Bristol Myers Squibb, Jansen, Leo Pharma, Novartis and Sanofi.

Reviewer disclosures

One reviewer has participated as PI/Si and/or invited speaker and/or advisor for Sanofi, Leo, Abbvie, Galderma, Pfizer. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded.

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