Research showing the effectiveness and safety of tralokinumab for the treatment of atopic dermatitis in adolescents

Atopic dermatitis (AD), or eczema, is a chronic disease causing painful, dry, itchy skin, which can negatively affect sleep, quality of life, and school performance. AD is caused by a combination of weakened skin barrier, altered immune system response, and imbalance in the common bacteria living on the skin surface. Tralokinumab is a medication targeting interleukin (IL)-13, a protein that drives the overactive immune response in AD. The ECZTRA 6 clinical trial tested the ability of tralokinumab to improve AD severity in adolescents.

Research Methods

Adolescents with moderate-to-severe AD received tralokinumab or nonactive drug (placebo). Patients meeting a threshold of improvement in AD severity after 16 weeks either continued treatment or received less frequent dosing for 8 additional months. Patients not meeting the target response (“non-responders”), received tralokinumab with optional use of topical corticosteroids. The medical team monitored patients and evaluated changes in AD symptoms and severity.

Key Takeaways

• At week 16, more patients treated with tralokinumab, compared to placebo, achieved clear/almost clear skin (Investigator’s Global Assessment score of 0 or 1 [IGA 0/1]), and experienced at least 75% improvement in the severity of AD (Eczema Area and Severity Index [EASI-75]).
• More patients treated with tralokinumab reported improvement in itch, sleep, and quality of life.
• Tralokinumab showed a long-lasting effect with a majority of patients (63%) who achieved clear/almost clear skin (IGA 0/1) at week 16 maintaining it at week 52.
• Additionally, 33% of Week 16 non-responders who then received tralokinumab with topical corticosteroids achieved clear/almost clear skin (IGA 0/1) at week 52.
• Most side effects were mild or moderate; the most common were upper respiratory tract infection (for example, common cold), dermatitis atopic (worsening of AD), injection-site reaction, asthma, and headache.

Conclusion

ECZTRA 6 was the first trial to demonstrate that tralokinumab improves AD and is well tolerated in adolescent patients. These findings support tralokinumab as an important long-term treatment option for adolescents with moderate-to-severe AD.