LEO Pharma marks 1 year of Adtralza in Korea with long-term data showing gains in hard-to-treat atopic dermatitis

Nearly a year after launching Adtralza (tralokinumab) in Korea with reimbursement backing, LEO Pharma returned to the podium with new data it hopes will cement the drug’s role in moderate-to-severe atopic dermatitis -- particularly in hard-to-treat regions like the head and neck.

Adtralza, approved in May 2024 for patients 12 and older who are not adequately controlled on topical treatments, is a monoclonal antibody that targets interleukin 13 (IL-13), a cytokine that drives inflammation in atopic dermatitis.

At a press conference Tuesday in Seoul, held to mark the one-year anniversary of the drug’s launch, medical experts presented updated findings from the long-term ECZTEND study and the global TRACE real-world trial.

The data, they said, confirmed Adtralza’s staying power on efficacy, safety, and quality-of-life -- and marked clear gains in visible lesion areas often linked to emotional and social strain.

“Long-term efficacy and safety remain key unmet needs in treating atopic dermatitis,” said Professor Lee Dong-hun of Dermatology at Seoul National University Hospital, citing six-year follow-up data from ECZTEND. “Adtralza has shown it can meet those needs, with strong real-world evidence from Korean clinical experience.”

By week 248 in the ECZTEND trial, 93 percent of patients reached EASI-75, a benchmark for clinical response, while 67 percent achieved “clear” or “almost clear” skin on the Investigator’s Global Assessment (IGA) scale, Lee said. He added that more than 70 percent maintained low disease activity (EASI ≤7) for over 80 percent of the treatment period, and fewer than 1 percent experienced paradoxical facial erythema -- an inflammatory flare-up in the face that runs counter to the drug’s anti-inflammatory purpose.

Professor Lee Ji-hyun of Dermatology at Seoul St. Mary’s Hospital emphasized the importance of Adtralza’s performance in head and neck lesions -- an area she said impacts 72 percent of moderate-to-severe patients and often triggers greater psychosocial burden.

In TRACE, 67 percent of patients had head and neck involvement at baseline, falling to 52 percent by month nine. Over the same period, the share of patients reporting improved quality of life rose from 58 percent to 74 percent. Korean data, presented alongside global results, showed a similar trajectory, Lee of Seoul St. Mary’s Hospital said.

LEO is also pursuing phase 3 trials in hand eczema and pediatric patients aged two and older. A pen-type injector is under development to streamline administration and support long-term use.