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Introduction <p>The tralokinumab pre-filled pen was developed to improve patient convenience and deliver 300&#xa0;mg tralokinumab (the recommended dose for most patients) with one injection. This study evaluated the efficacy, safety, and usability of the tralokinumab pre-filled pen autoinjector in patients with moderate-to-severe atopic dermatitis.</p> Methods <p>This 16-week, open-label, single-arm phase 3 study enrolled patients ≥ 12&#xa0;years with Investigator’s Global Assessment (IGA) score ≥ 3 and Eczema Area and Severity Index (EASI) ≥ 12. Patients received tralokinumab 300&#xa0;mg via self-administered pre-filled pen every 2&#xa0;weeks for 16&#xa0;weeks. The primary endpoints were IGA 0/1 and ≥ 75% improvement in EASI (EASI-75) at week&#xa0;16. Safety was assessed as the number of adverse events from baseline to week 16.</p> Results <p>At week 16, 28.7% (39/136) of patients achieved IGA 0/1 (28.6% [30/105] adults; 29.0% [9/31] adolescents) and 43.4% (59/136) of patients achieved EASI-75 (44.8% [47/105] adults; 38.7% [12/31] adolescents). The tralokinumab pre-filled pen was well tolerated, and the observed safety profile was comparable to the safety profile with the tralokinumab pre-filled syringe.</p> Conclusions <p>Tralokinumab formulated as a pre-filled pen was effective, well tolerated, and easy to use. The tralokinumab pre-filled pen may offer a more convenient method of tralokinumab administration with fewer injections per dose.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT05194540.</p>

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The Tralokinumab Pre-Filled Pen Improved Atopic Dermatitis Signs and Symptoms and Was Well Tolerated in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: A 16-Week, Open-Label, Single-Arm Phase 3 Study (INJECZTRA)

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  • 发表日期：

    2025年7月18日

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  • Jennifer Soung,
  • Vivian Laquer,
  • Matthew Zirwas,
  • Peter van Iperen,
  • John C. Stinson,
  • Katrine Lykke Albertsen,
  • Linda Stein Gold

摘要

Introduction

The tralokinumab pre-filled pen was developed to improve patient convenience and deliver 300 mg tralokinumab (the recommended dose for most patients) with one injection. This study evaluated the efficacy, safety, and usability of the tralokinumab pre-filled pen autoinjector in patients with moderate-to-severe atopic dermatitis.

Methods

This 16-week, open-label, single-arm phase 3 study enrolled patients ≥ 12 years with Investigator’s Global Assessment (IGA) score ≥ 3 and Eczema Area and Severity Index (EASI) ≥ 12. Patients received tralokinumab 300 mg via self-administered pre-filled pen every 2 weeks for 16 weeks. The primary endpoints were IGA 0/1 and ≥ 75% improvement in EASI (EASI-75) at week 16. Safety was assessed as the number of adverse events from baseline to week 16.

Results

At week 16, 28.7% (39/136) of patients achieved IGA 0/1 (28.6% [30/105] adults; 29.0% [9/31] adolescents) and 43.4% (59/136) of patients achieved EASI-75 (44.8% [47/105] adults; 38.7% [12/31] adolescents). The tralokinumab pre-filled pen was well tolerated, and the observed safety profile was comparable to the safety profile with the tralokinumab pre-filled syringe.

Conclusions

Tralokinumab formulated as a pre-filled pen was effective, well tolerated, and easy to use. The tralokinumab pre-filled pen may offer a more convenient method of tralokinumab administration with fewer injections per dose.

Trial Registration

ClinicalTrials.gov identifier, NCT05194540.