Positive Long-Term Safety Data for Tralokinumab in Patients with AD

Data from the 5-year extension trial ECZTEND indicated that the overall safety profile of tralokinumab was consistent with the previous ECZTRA trials.

LEO Pharma presented the longest-term safety data in atopic dermatitis for tralokinumab, a biologic that targets interleukin 13 (IL-13) in affected patients, this weekend at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston, MA.

The 3.5-year interim analysis, ECZTEND, was an open-label, 5-year extension trial that indicated that the overall safety profile of tralokinumab was consistent with the previous ECZTRA trials, with no new safety signals being observed.

A sustained improvement was observed in the analysis in relation to the extent and severity of the disease, itch severity, and quality of life in adult patients.

Additionally, among the 616 patients who received the therapy for 3 years, 85.1% achieved at least a 75% improvement in the Eczema Area and Severity Index score (EASI-75).

“With some patients with over 3 years of use on continuous tralokinumab, we're seeing continued efficacy, very nice maintenance of responses, if you will, without any additional safety signals, we're not seeing new things arise with longer treatment,” said Andrew Blauvelt, MD, President of Oregon Medical Research Center. “So for me, the bottom line is, this drug does very well over time in patients with moderate to severe AD and keeping their disease, in my view, either absent or at a minimum in a safe manner. And we need that kind of drug, we need drugs that are safe and effective over the long term.”

The ECZTEND trial built upon the success of the previous 8 ECZTRA parent trials, one of which evaluated the effectiveness of tralokinumab as a combination therapy.

In the analysis, the safety profile of tralokinumab 300 mg was consistent with previous data when paired with optional corticosteroids. However, Blauvelt noted that data regarding tralokinumab remains limited.

“In my experience, patients are using topical therapy (for) lesions here and there, maybe a particularly bad area that they're having trouble with,” he said. “They're not using it all over as their primary treatment for their AD as they would if they weren't on a systemic agent. So, when we see topical steroid use it's always pretty minimal…it's not like those patients are using heavy amounts when it's combined with a systemic agent like tralokinumab.”

As with previous parents trials, adverse events (AE) were recorded in the ECZTEND trial, with discontinuation rates due to AEs being 2.4%. Among these events were headaches, upper respiratory infections, and conjunctivitis.

Despite this, Blauvelt noted that the safety profile of tralokinumab remained positive and was superior to other biologics such as dupilumab.

“I think there's a lower percentage of patients having conjunctivitis, less than 10% and again, my view of the data and experience with dupilumab is that number is over 10% both in the literature and with my personal experience,” Blauvelt said. “So, I think by targeting IL-13 alone and not IL-4 for an IL-13 like we are doing with dupilumab that perhaps we're gaining a little bit of a safety improvement in terms of the percentage of patients who get conjunctivitis.”