he use of Adbry in adolescent patients aged 12-17 is currently under clinical investigation and the safety and efficacy have not been fully evaluated by the U.S. FDA.

Leo Pharma’s Adbry (tralokinumab-ldrm) significantly reduced the abundance of Staphylococcus aureus in the lesional and non-lesional skin of adolescents with atopic dermatitis (AD) after 16 weeks, according to new data presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting. 

At Week 16 of the ECZTRA 6, 49 percent of patients receiving Adbry 150 mg (n=81) and 43 percent of patients receiving Adbry 300 mg (n=82) went from testing positive for S. aureus to negative in lesional skin, compared to the 14 percent receiving placebo (n=80). Similar reductions were seen in Adbry-treated patients with S. aureus positive non-lesional skin.

Adbry was approved for adults with moderate-to-severe atopic dermatitis by the U.S. Food and Drug Administration (FDA) in December 2021. The use of Adbry in adolescent patients aged 12-17 is currently under clinical investigation and the safety and efficacy have not been fully evaluated by the U.S. FDA.

“Patients with atopic dermatitis are often colonized with high levels of S. aureus,” says Prof. Lisa Beck, Department of Dermatology, University of Rochester Medical Center, and the lead investigator on this analysis, in a news release.  “These data demonstrate the impact of Adbry’s IL-13 neutralization in effectively reducing S. aureus abundance in adolescents, an important factor in the aggravation of skin lesions and skin infections.”

Additional data in adolescent patients from ECZTRA 6 demonstrated that 16 weeks of treatment with Adbry showed an improvement in skin gene expression from a lesional to a non-lesional skin profile. The improvement occurred in 29 percent (n=29) and 41 percent (n=27) of the differentially expressed genes in lesional skin in patients treated with Adbry (for the 150 mg and 300 mg groups, respectively), compared to a 4 percent improvement in the placebo group (n=27). At Week 8, Adbry 150 mg and 300 mg led to 35 percent (n=29) and 33 percent  (n=27) improvement respectively in gene expression, compared to a 10 percent (n=27) improvement with placebo.2

All participants who completed the ECZTRA 6 trial were eligible to enter the ongoing ECZTEND open-label extension trial. An interim analysis of this trial, also presented at AAD, evaluated the long-term safety and efficacy of Adbry among adolescents from ECZTRA 6 who moved into ECZTEND.

The results of the analysis showed that the long-term safety profile of Adbry for up to three years in the adolescent population (n=127) was consistent with that of the ECZTEND adult population, with no new safety issues identified. The pattern of frequently reported adverse events (AEs) in ECZTEND was similar to that observed with Adbry in the parent trial, although at lower rates. The most frequently reported AEs in the ECZTEND adolescent population were viral upper respiratory tract infection (11.9 events per 100 patient years of exposure (PYE)), dermatitis atopic (7.4 events per 100 PYE), and upper respiratory tract infections (4.5 events per 100 PYE).3 Of note, was the lower frequency rate of conjunctivitis observed in patients being treated with Adbry compared to those in the placebo group. Of the AEs of special interest, no events of keratitis or keratoconjunctivitis, eczema herpeticum skin infections requiring systemic treatment, or malignancies were reported.

Additionally, approximately eight out of 10 patients had at least a 75% improvement in the extent and severity of AD (EASI-75) at two years of treatment with Adtralza (84.4% AO (n=109), 78.7% mNRI (n=127), 78.7% LOCF (n=127), the study showed.

“These new insights from the ECZTRA 6 study further develop our understanding of how Adbry works in adolescent patients and its effect on the spread of S. aureus colonization, a common and significant issue that can exacerbate skin infections,” says Jörg Möller, Executive Vice President, Global Research & Development, LEO Pharma. “In addition, the latest analysis of data from adolescents in the ECZTEND study shows the long-term safety and efficacy profile of Adbry. Our goal is to use these findings to better inform disease management strategies for healthcare providers and their patients.”

Adbry is marketed outside of the U.S. under the tradename Adtralza and is approved for the treatment of adults and adolescents with moderate-to-severe AD in Canada, the European Union, and Great Britain. Adtralza is approved for use in adults with moderate-to-severe AD in the U.S., United Arab Emirates, Switzerland, and Japan.