Real-World Data Highlights Effectiveness of Tralokinumab in Atopic Dermatitis

Jonathan Silverberg, MD, PhD, MPH
Credit: George Washington University

A study leveraging real-world data form patients with atopic dermatitis is shedding new light on the effects of tralokinumab among patients with and without previous treatment with advanced systemic therapy.

Results of the study, which included data from 60 patients treated with tralokinumab, suggested use of the IL-13 inhibitor provided manful improvements for clinician-assessed and patient-reported outcomes.

“In this real-world study, patients with [atopic dermatitis] experienced notable improvements in both clinician-assessed and patient-reported outcomes after 6-months of persistent tralokinumab treatment, regardless of prior AST therapy use,” wrote investigators.¹

An IL-13 inhibitor from Leo Pharma, tralokinumab received its first approval from the FDA with an indication for moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable in December 2021. Two years later, in 2023, tralokinumab received a label expansion for the same indication, but now including patients aged 12 to 17 years.^2,3

Presented at the Revolutionizing Atopic Dermatitis (RAD) 2024 annual meeting by Jonathan Silverberg, MD, PhD, MPH, director of clinical research at George Washington University’s School of Medicine and Health Sciences, the current study was launched with the intent of better understanding the effects of tralokinumab on clinician-assessed and patient-reported outcomes among adults with atopic dermatitis in real-world settings. With this in mind, investigators designed the study as an analysis of data obtained from the CorEvitas AD Registry.¹

A prospective, non-interventional registry launched in 2020 for adults with atopic dermatitis receiving care from a license dermatologist or qualified dermatology practitioner, CorEvitas provided investigators with data from 60 US adult patients who initiated therapy with tralokinumab between February 1, 2022 and May 31, 2023. For inclusion in the analysis, investigators required patient to have persistent tralokinumab use at 6 months of follow-up, which investigators defined as a visit occurring 5 to 9 months after tralokinumab.¹

The primary outcomes of interest were change from baseline in validated Investigator’s Global Assessment for atopic dermatitis (vIGA-AD), a 50% or greater and 75% or greater improvement in Eczema Area and Severity Index (EASI), a 4-point or greater improvement in Dermatology Life Quality Index (DLQI), a 3-point or greater improvement in mean weekly pruritis numerical rating scale, and mean change in Work Productivity and Activity Impairment (WPAI).¹

The 60-patient cohort identified for inclusion had a mean age of 49.1 years, 56.7% were female, 85.0% were White, 63.3% worked full-time, 73.3% were naive to advanced systemic therapy, and a mean of 15.0 years since diagnosis of atopic dermatitis. ¹

In the RAD 2024 presentation, investigators highlighted the proportion of patients experiencing improvements in clinician-assessed endpoints and PROs from baseline to 6 months, which are detailed below:¹

• Proportion with vIGA-AD less than 1 increased from 6.7% to 55.0%
• Proportion with EASI 7 or less increased from 33.3% to 85.0%
• Proportion with DLQI 5 or less increased from 38.3% to 66.7%

Investigators also highlighted 85.0% of those with an EASI of 7.1 or greater at baseline achieved EASI-50, including AST-naïve: 90.9% of the advanced systemic therapy-naive group and 57.1% advanced systemic therapy group at the 6-month follow-up. Further analysis indicated77.5% achieved EASI-75, including 84.8% of the advanced systemic therapy-naïve group and42.9% of the advanced systemic therapy at the 6-month follow-up.¹

“These findings support the therapeutic potential of tralokinumab for [atopic dermatitis] patients, highlighting the need for future studies with longer follow-up period and larger sample size,” investigators wrote.¹

References:

1. ^{Silverberg J, Balu S, Choi CJ, et al. Real-world effectiveness of persistent tralokinumab use on clinician and patient-reported outcomes in patients with atopic dermatitis in the CorEvitas atopic dermatitis registry. Abstract presented at Revolutionizing Atopic Dermatitis 2024. Chicago, Il. June 08-10, 2024.}
2. ^{Butera A. FDA approves tralokinumab-ldrm for atopic dermatitis in adults. HCP Live. December 28, 2021. Accessed June 8, 2024. https://www.hcplive.com/view/fda-approves-tralokinumab-ldrm-atopic-dermatitis-adults.}
3. ^{National Eczema Association. Leo Pharma Inc.. announces U.S. FDA approval of Adbry® (tralokinumab-LDRM) for the treatment of moderate-to-severe atopic dermatitis in pediatric patients aged 12-17 years. National Eczema Association. December 15, 2023. Accessed June 8, 2024. https://nationaleczema.org/blog/leo-121523/.}