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New data from the ECZTRA 6 trial noted improvements in itch, sleep interference, anxiety and more.
LEO Pharma announced new 16-week data on tralokinumab-ldrm, stating that it led to significant improvements in itch, sleep interference, anxiety and depression, and overall quality of life among adolescents aged 12-17 years old with moderate-to-severe atopic dermatitis.
The data were presented at the Western Society of Allergy, Asthma & Immunology (WSAAI) 59th Annual Scientific Session in Maui.
Tralokinumab-ldrm was previously approved by the US Food and Drugs Administration (FDA) in December 2021 for the treatment of adults with moderate-to-severe atopic dermatitis. It is the first and only FDA approved biologic that binds to and inhibits the interleukin (IL)-13 cytokine.
The most recent analysis evaluated patient-reported outcomes with the biologic compared to placebo at week 16 during the 52-week monotherapy phase 3 ECZTRA 6 trial.
A total of 100 patients received 150 mg of tralokinumab-ldrm, while 101 received 300 mg of the biologic. Investigators observed that siginificantly more adolescent patients achieved improvements with the biologic every 2 weeks compared to the 100 patients who received placebo.
A ≥4-point improvement in adolescent Worst Daily Pruritus Numeric Rating Scale (NRS) was seen in 23.2% of patients receiving tralokinumab-ldrm 150 mg (P<0.001), 25.0% of those in the tralokinumab-ldrm 300 mg group (P<0.001), and 3.3% placebo, while a ≥6-point improvement in Children’s Dermatology Life Quality Index (CDLQI) was recorded in 31.0% of patients receiving tralokinumab-ldrm 150 mg (P=0.029), 39.5% tralokinumab-ldrm 300 mg (P<0.001), and 15.9% placebo.
Additionally, a ≥6-point improvement in Patient Oriented Eczema Measure (POEM) was reported in 38.7% of the tralokinumab-ldrm 150 mg group (P<0.001), 46.8% of the tralokinumab-ldrm 300 mg group, (P<0.001), and 10.5% of the placebo group. The biologic was also associated with greater improvement than placebo in eczema-related sleep NRS.
Currently, Tralokinumab-lfrm is not FDA approved in adolescents, and its efficacy and safety have not been full evaluated.