Long-Term Tralokinumab Safe, Effective After 6 Years for Atopic Dermatitis

Credit: Andrew Blauvelt, MD, MBA

Credit: Maui Derm

There are no new safety signals identified in adults and adolescent patients aged 12 years and over with moderate-to-severe atopic dermatitis treated for up to 6 years with tralokinumab-ldrm (Adbry), according to new long-term data presented at the 2024 Fall Clinical Dermatology Conference in Las Vegas.^1,2

These new data also indicate that long-term tralokinumab-ldrm therapy demonstrated sustained efficacy after up to 6 years, as suggested through the drug’s reduction of at least 75% in patients’ Eczema Area and Severity Index scores (EASI-75). These findings were all the result of the 5-year, phase 3 extension study known as ECZTEND.

“These long-term findings are crucial for clinical practice, providing healthcare professionals with the data needed to prescribe tralokinumab-ldrm for sustained use confidently,” Andrew Blauvelt, MD, MBA, an International Coordinating Investigator of ECZTEND, said in a statement. “Ultimately, these comprehensive results will help improve their ability to manage this debilitating condition and enhance patient care.”¹

Atopic dermatitis is a chronic, inflammatory skin condition characterized by intense pruritus as well as eczematous lesions, resulting from chronic inflammation among patients. Type 2 cytokines such as interleukin (IL)-13 are known to be involved in the key elements of the skin disease’s pathophysiology.

Tralokinumab-ldrm was developed as a high-affinity fully human monoclonal antibody that binds to and inhibits the aforementioned IL-13 cytokine. Once it binds to the cytokine, the treatment thereby inhibits interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2).

The phase 3 ECZTEND study was designed as a long-term, open-label, multi-center trial assessing the prolonged safety and efficacy of tralokinumab-ldrm among those with moderate-to-severe atopic dermatitis who are aged 12 and older. There were 1672 ECZTEND participants who had completed prior treatment with tralokinumab-ldrm in 1 of 9 initial analyses and were invited to take part.

In earlier interim analyses from the study, tralokinumab-ldrm was shown to be both safe and efficacious for individuals on the therapy observed up to 4.5 years.

In the latest findings, covering up to a year in the parent studies and nearly 5 in ECZTEND, there were no new safety concerns and the safety profile of the medication was shown by the investigators to be consistent with that observed during the initial placebo-controlled phases of the earlier studies. Additionally, adverse events were generally found to be mild or moderate and occurred at lower rates during the extension trial.

In terms of long-term efficacy, findings indicated that after up to 6 years of treatment with tralokinumab-ldrm, 92.9% of subjects succeeded in achieving at least EASI-75 by the 248-week mark. In addition, the research team concluded that 66.7% of participants succeeded in achieving a score of 0 or 1 on the Investigator's Global Assessment (IGA), suggesting clear or almost clear skin.¹

Lastly, the investigators noted that subjects treated with the medication also reported significant improvements in relief from itch, in sleep, and in overall quality of life.

"With the release of the final results from the ECZTEND open-label extension study, we are pleased to present robust evidence further supporting the long-term safety and efficacy of tralokinumab-ldrm in the treatment of moderate-to-severe atopic dermatitis," Brian Hilberdink, EVP and president of Region North America at LEO Pharma, said in a statement.¹

References

1. ^{LEO Pharma Presents Final Results of ECZTEND Long-Term Adbry® Trial (tralokinumab-ldrm) in Patients with Moderate-to-Severe Atopic Dermatitis (AD) at Fall Clinical 2024. LEO Pharma. October 25, 2024. https://www.businesswire.com/news/home/20241025193860/en/LEO-Pharma-Presents-Final-Results-of-ECZTEND-Long-Term-Adbry%C2%AE-Trial-tralokinumab-ldrm-in-Patients-with-Moderate-to-Severe-Atopic-Dermatitis-AD-at-Fall-Clinical-2024. Date accessed: October 25, 2024.}
2. ^{Blauvelt A, Laquer V, Langley RG, et al. Long-term safety and efficacy of tralokinumab in adults and adolescents with moderate-to-severe atopic dermatitis treated for up to 6 years. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.}