Tralokinumab Linked to Overall Quality of Life Improvements in Adolescents with AD

February 7, 2022
Armand Butera

Armand Butera is the assistant editor for HCPLive. He attended Fairleigh Dickinson University and graduated with a degree in communications with a concentration in journalism. Prior to graduating, Armand worked as the editor-in-chief of his college newspaper and a radio host for WFDU. He went on to work as a copywriter, freelancer, and human resources assistant before joining HCPLive. In his spare time, he enjoys reading, writing, traveling with his companion and spinning vinyl records. Email him at abutera@mjhlifesciences.com.

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.


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