乌鸦传媒

In a post-hoc analysis of 75 older adults, tralokinumab (Adbry) was safe, well tolerated, and efficacious in treating moderate-to-severe atopic dermatitis (AD).

A brief report describing the findings of the post-analysis appeared recently in .

Tralokinumab is an IL-13 inhibitor approved by the FDA for people ages 12 and older who have moderate-to-severe AD not adequately controlled by topical therapies or when those therapies are contraindicated.

The analysis used data for patients ages 65 or older who participated in the ECZTRA trials -- a set of three randomized, placebo-controlled, phase 3 trials conducted in the U.S., Canada, Europe, and Asia.

More patients achieved 75% or greater improvement in AD area and severity scores with tralokinumab than placebo (33.9% vs 4.8%; P<.001) in the first two ECZTRA trials; similar but statistically insignificant trends occurred in the third trial. Generally, safety and efficacy outcomes in this population were comparable to those observed in younger patients.

The following study excerpts have been edited for length and clarity.

What prompted this analysis?

Despite their greater disease burden, older adults can often be underrepresented in clinical trials. Further, treatment for moderate-to-severe disease can be challenging, as older adults can experience more active and severe disease, increased comorbidity, polypharmacy, and a higher risk of infection. Other key challenges include safety risks and low adherence to conventional therapies.

This subgroup analysis evaluated the safety and efficacy of tralokinumab in adults ages 65 or older with moderate- to-severe AD.

What did the study find about the drug's efficacy?

The trends observed suggest tralokinumab has similar efficacy among all age cohorts.

When compared to patients included in the current analysis, similar efficacy results were seen among patients ages 18-49 and 50-64. Differences between treatment effects in the different age groups were not statistically significant.

What were the findings related to safety?

Similar proportions of patients reported adverse events (AEs) in the tralokinumab and placebo groups.

Three patients (4%) in the tralokinumab arm and 3 (10.3%) in the placebo arm experienced severe AEs; 4 (5.3%) patients and 2 (6.9%) patients in the respective groups experienced AEs that led to discontinuation of the treatment.

Although more than half of older adults in the tralokinumab and placebo groups experienced AEs, only 5.3% and 6.9% of these patients, respectively, had events that led to discontinuation.

What is the key take-home message?

These findings suggest that tralokinumab is safe and effective for older adults with moderate-to-severe AD.