For patients with moderate-to-severe atopic dermatitis, two years of tralokinumab treatment is safe and efficacious, according to a study published online July 18 in the Journal of the American Academy of Dermatology .

Andrew Blauvelt, M.D., from Oregon Medical Research Center in Portland, and colleagues examined the safety and efficacy of up to two years of tralokinumab treatment in a post hoc interim analysis. The safety analysis included 1,174 adult patients from completed parent trials enrolled in an ongoing five-year extension trial (ECZTEND), regardless of tralokinumab exposure duration. Efficacy analyses included adults in ECZTEND treated with tralokinumab for one or more years; subgroup analyses included 345 patients on tralokinumab for two years (one year from parent trial and one year in ECZTEND).

The researchers found that the exposure-adjusted rate of adverse events was 237.8/100 patient-years exposure for participants on tralokinumab in the safety analysis. For common adverse events, exposure-adjusted incidence rates were comparable to those in parent trials, although the rates were lower. Improvements in the extent and severity of atopic dermatitis were sustained with two years of tralokinumab, with a 75 percent improvement in the Eczema Area and Severity Index reported in 82.5 percent of participants.

"These data support specific inhibition of interleukin-13 with tralokinumab as a safe and efficacious option for the long-term treatment of moderate-to-severe atopic dermatitis," the authors write.

Several authors disclosed financial ties to biopharmaceutical companies, including LEO Pharma, which manufactures tralokinumab and sponsored the ECZTEND clinical trial.

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