Tralokinumab improves symptoms for adolescents with moderate to severe atopic dermatitis

Treatment with tralokinumab significantly improved symptoms among adolescents with moderate to severe atopic dermatitis, according to a study presented at the Western Society of Allergy, Asthma & Immunology Annual Scientific Meeting.

“We’ve always known that atopic dermatitis (AD) is a big risk factor for the development of allergies, including allergic rhinitis, asthma and food allergies,” Weily Soong, MD, chief medical officer at AllerVie Health, told Healio.

After discovering that IL-13 cytokines drive type 2 inflammation, which in turn drives cutaneous barrier dysfunction, inflammation and dysbiosis in AD, the researchers developed tralokinumab (Adbry, LEO Pharma), which they called the first fully human, monoclonal antibody designed to bind with and neutralize IL-13.

AD can significantly impact quality of life for adolescents, the researchers said, with negative effects on school performance, social relationships and participation in sports. Also, adolescents with AD have increased rates of anxiety, depression and suicidal ideation, according to the researchers.

Weily Soong

“In my experience, a lot of adults have developed coping strategies for their AD — the constant itching and all the lesions. And they also probably have coping strategies to hide their lesions,” said Soong, who also is medical director of the Clinical Research Center of Alabama. “Adolescents have a harder time handling AD.”

The FDA has approved tralokinumab for adults with moderate to severe AD whose AD is not adequately controlled with topical prescriptions or when those therapies are not advisable. However, adolescents currently rely on creams, lotions and anti-itching medication such as antihistamines, which Soong said are not very effective.

“Primary care providers and pediatricians sometimes underappreciate the huge quality-of-life impact that AD has. A lot of people tell this group of adolescents they should just put more cream on, and adolescents are trying really hard and get frustrated,” Soong said.

“It also places a lot of burden on these patients, trying to constantly use creams and lotions,” Soong continued. “Now with the advent of biologics, and with tralokinumab targeting IL-13, we actually now have new ways to treat this and really make a huge impact on adolescents’ lives and peoples’ lives.”

The randomized, double-blind, placebo-controlled, parallel-group multicenter study examined patients aged 12 to 17 years who had AD for a year or longer. Researchers randomly assigned patients to receive 150 mg (n = 98) or 300 mg (n = 97) of tralokinumab or placebo (n = 94) as a monotherapy every 2 weeks for 16 weeks.

After 16 weeks, more patients on tralokinumab than placebo saw an improvement of four points or more in their adolescent worst daily pruritus numerical rating scale (150 mg: 23.2%; 300 mg: 25%; placebo, 3.3%; P < .001 for both).

Compared with 15.9% of patients assigned placebo, more patients on tralokinumab saw an improvement of six points or more in Children’s Dermatology Life Quality Index (150 mg: 31%; P = .029; 300 mg: 39.5%; P < .001).

Also, a greater proportion of those assigned tralokinumab compared with placebo achieved an improvement of six points or more on the Patient Oriented Eczema Measure (150 mg: 38.7%; 300 mg: 46.8%; placebo, 10.5%; P < .001 for both).

Further, the researchers found both doses of tralokinumab yielded greater improvements in eczema-related sleep numerical rating scale, and the 300 mg dose yielded improvements on the Hospital Anxiety and Depression Scale compared with placebo.

“Tralokinumab was very effective in adolescents with their lesions, quality-of-life measurements and itching,” Soong said. “So, there is another biologic that can be used in this population with moderate to severe AD.”

Soong said that the study’s results matched his expectations.

“I personally felt like it would do very well in the adolescent population. But again, that’s the reason why you do clinical trials — to prove your theory,” Soong said.

“The adolescents going through the study were just very happy to see the improvements in their lesions, itching and quality of life. They’re very satisfied,” he added.

The ongoing study has now surpassed 52 weeks, Soong said, and will continue into the next couple of years so the researchers can evaluate the treatment’s safety and efficacy. Trials for patients aged 6 to 12 years also are being developed, Soong said, adding that he believes we are entering a “golden age” of AD treatment.

“It’s been a long journey in watching these children, adolescents and adults suffering from atopic dermatitis. It has always been heartbreaking, because the treatments have been very limited at the time,” he said. “Now that we have biologics like tralokinumab, it’s been a lot of fun watching patients get better.”