Therapeutic Potential of Tralokinumab in the Treatment of Atopic Dermatitis: A Review on the Emerging Clinical Data

Abstract

Atopic dermatitis (AD) is a chronic inflammatory skin disease that greatly impacts patient quality of life. Type 2 cytokine interleukin (IL)-13 is integral to the pathogenesis of AD. Tralokinumab is a fully human IgG4 monoclonal antibody that specifically targets IL-13, preventing downstream signaling of inflammatory pathways that may contribute to AD. Tralokinumab was US Food and Drug administration (FDA) recently approved for the treatment of moderate to severe AD on December 28, 2021. In our review, we will explore the efficacy and adverse effects (AEs) of tralokinumab for the treatment of patients with moderate to severe AD. A PubMed search for key articles on the emerging clinical data of tralokinumab was performed. Six randomized controlled trials of tralokinumab identified improvements in disease severity measures, including Investigator’s Global Assessment (IGA) scores and Eczema Area Severity Index 75 (EASI75) scores. Four of these studies demonstrated improvements in quality of life measures with tralokinumab, including pruritus scores, sleep interference scores, Dermatology Life Quality Index, SCORing Atopic Dermatitis (SCORAD), Patient Oriented Eczema Measure, and The Short Form 36 Health Survey (SF-36v2) scores. One study identified a similar immune response in patients taking tralokinumab to those taking the Tdap and meningococcal vaccines. Upper respiratory infection, conjunctivitis, and headaches were the most common adverse events. The varying criteria to assess changes in AD disease severity across different studies is a limitation of this review. Tralokinumab is another promising biologic option for the treatment of moderate to severe AD, which may reduce disease burden and improve patient quality of life.

Cendakimab in Patients With Moderate to Severe Atopic Dermatitis

“…21,26,27 Despite differences in dosing regimens and treatment duration, the proportion of patients achieving EASI-75, vIGA 0 or 1, and P-NRS-4 were overall similar to proportions from previous studies with biologics that block IL-13 function. 9,10 Treatment with cendakimab, an anti-IL-13 monoclonal antibody that blocks the interaction of IL-13 with IL-13Rα1 and IL-13Rα2, also decreased inflammatory biomarkers in this study. Specifically, cendakimab decreased levels of key inflammatory and remodeling biomarkers (eotaxin-3, periostin, and MMP-12) during 16 weeks of treatment.…”

“…Safety findings from this study were similar to findings in other phase 2 studies of biologic agents targeting IL-4 and IL-13 for treating moderate to severe AD. 9,10,22,23,26,29 TEAEs were similar across treatment groups, with most events reported as mild or moderate. Rates of serious AEs were similar across groups.…”

“…In particular, targeted biologic therapies are often required to treat moderate to severe AD. Biologics currently approved by the US Food and Drug Administration for first-line systemic therapy in moderate to severe AD include dupilumab and tralokinumab, which are anti–interleukin (IL)–4 receptor alpha (Rα) and anti–IL-13 monoclonal antibodies, respectively . Janus kinase inhibitors are an approved alternative for patients with moderate to severe AD who experienced an inadequate response to other biologic or systemic therapies, but these require laboratory monitoring and periodic safety monitoring …”

Long-Term Effectiveness and Safety of Biologic and Small Molecule Drugs for Moderate to Severe Atopic Dermatitis: A Systematic Review

“…The reduction in the frequency of application and the total consumption (measured in grams) of topical corticosteroids as an adjuvant to new systemic therapies would be interesting. Tralokinumab is currently the only drug that has recorded this aspect, showing a reduction in both variables [ 15 ].…”

Immunopathogenesis of Atopic Dermatitis: Focus on Interleukins as Disease Drivers and Therapeutic Targets for Novel Treatments

“…A review of the therapeutic potential of tralokinumab in the treatment of AD published by Kelly et al [133] revealed improvements in disease severity measures (including IGA scores and EASI-75 scores), and in quality of life (including pruritus scores; sleep interference scores; DLQI; SCORing Atopic Dermatitis, SCORAD; Patient Oriented Eczema Measure; and The Short Form 36 Health Survey).…”