Review of Tralokinumab in the Treatment of Atopic Dermatitis

Abstract

Objective To review pharmacokinetics, efficacy, and safety of tralokinumab in treatment of atopic dermatitis (AD). Data Sources Literature review was conducted using MEDLINE (PubMed), EMBASE, and ClinicalTrials.gov for articles published between January 2010 and May 2022. Study selection and data extraction Articles in English discussing tralokinumab in AD were included. Data synthesis In one phase 2 trial, more subjects treated with tralokinumab 150 and 300 mg achieved an Investigator’s Global Assessment (IGA) of 0/1 with minimum ≥2 point IGA reduction (23%), versus placebo (11.8%, P = 0.10). During 2 phase 3 trials, more subjects treated with tralokinumab achieved IGA success (ECZTRA 1: 15.8% and ECZTRA 2: 22.2%), versus placebo (7.1% and 10.9%, respectively; P = 0.002 and P < 0.001). During one phase 3 trial, in conjunction with topical corticosteroids (TCS), more subjects treated with tralokinumab 300 mg achieved IGA success (ECZTRA 3: 38.9%), versus placebo (26.2%, P = 0.015). During another phase 3 trial in subjects with resistance or contraindication to oral cyclosporine, more subjects treated with tralokinumab 300 mg achieved an Eczema Area Severity Index 75 (64.2%), versus placebo (50.5%, P = 0.018). Relevance to patient care and clinical practice Tralokinumab is efficacious for moderate-to-severe AD, as monotherapy, in conjunction with TCS, and resistance or contraindication to cyclosporine. Although IL-4 and IL-13 are both implicated in AD’s pathogenesis, IL-13 is overexpressed, and head-to-head trials are needed to assess efficacy of tralokinumab, versus dupilumab. Compared with upadacitinib and abrocitinib, tralokinumab is not associated with black-box warnings. Conclusions Tralokinumab is an efficacious and safe systemic treatment for moderate-to-severe AD.

The evolving landscape of biologic therapies for atopic dermatitis: Present and future perspective

“…To the best of our knowledge there are no studies published that have directly compared efficacy of the already approved biologics, tralokinumab and dupilumab. 91 However, a head to head study of IL-4 or IL-13 inhibition versus dual IL-4/IL-13 inhibition in a mouse asthma model showed that only dual blockage prevented eosinophil infiltration into lung tissue and protection from allergen-induced impairment, suggesting that blockage of both cytokines is superior. 65 However, positive clinical data showing downregulation of type 2-related biomarkers with biologics targeting IL-13, exclusively, suggest that this approach also holds therapeutic potential.…”

“…Different study designs limit the ability to compare findings and draw conclusions about biologics' efficacies relative to one another. To the best of our knowledge there are no studies published that have directly compared efficacy of the already approved biologics, tralokinumab and dupilumab 91 . However, a head to head study of IL‐4 or IL‐13 inhibition versus dual IL‐4/IL‐13 inhibition in a mouse asthma model showed that only dual blockage prevented eosinophil infiltration into lung tissue and protection from allergen‐induced impairment, suggesting that blockage of both cytokines is superior 65 .…”