Tralokinumab therapy for moderate-to-severe atopic dermatitis: Clinical outcomes with targeted IL-13 inhibition

Allergy. 2023 Nov;78(11):2875-2891. doi: 10.1111/all.15811. Epub 2023 Jul 16.

Abstract

Atopic dermatitis (AD) is a chronic, inflammatory, intensely pruritic skin disorder associated with significant patient burden. Interleukin (IL)-13 is a cytokine that acts as a driver of immune dysregulation, skin-barrier dysfunction, and microbiome dysbiosis that characterizes AD, and is consistently overexpressed in AD skin. Tralokinumab is a fully human immunoglobulin (Ig) G4 monoclonal antibody that binds specifically to IL-13 with high affinity, thereby inhibiting subsequent downstream IL-13 signaling. Three pivotal phase 3 clinical trials demonstrated that tralokinumab 300 mg every other week, as monotherapy or in combination with topical corticosteroids as needed, provides significant improvements in signs and symptoms of moderate-to-severe AD, as measured by Investigator's Global Assessment 0/1 (clear/almost clear) and Eczema Area and Severity Index-75 at Week 16. Improvements were observed soon after tralokinumab initiation and were maintained over 52 weeks of therapy. Tralokinumab significantly improved patient-reported outcomes such as itch and sleep, and demonstrated a safety profile comparable with placebo; conjunctivitis during tralokinumab therapy was generally mild. Similar results were observed in a phase 3 adolescent trial. The role of IL-13 in the pathophysiology of AD justifies a targeted approach and a wealth of clinical data supports tralokinumab as a new therapeutic option for people with moderate-to-severe AD.

Keywords: atopic dermatitis; interleukin-13; tralokinumab.

Publication types

  • Review

MeSH terms

  • Adolescent
  • Antibodies, Monoclonal / therapeutic use
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Dermatitis, Atopic* / diagnosis
  • Dermatitis, Atopic* / drug therapy
  • Double-Blind Method
  • Humans
  • Immunoglobulin G
  • Injections, Subcutaneous
  • Interleukin-13
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • tralokinumab
  • Interleukin-13
  • Antibodies, Monoclonal, Humanized
  • Antibodies, Monoclonal
  • Immunoglobulin G

Grants and funding