FDA Approves Tralokinumab for Adolescents With Atopic Dermatitis

FDA Approval Illustration | Image Credit: bakhtiarzein - stock.adobe.com

Originally approved in December 2021 for adults with atopic dermatitis (AD), LEO Pharma, announced that tralokinumab-ldrm (Adbry) is now FDA-approved for pediatric patients aged 12 to 17 years old.

The chronic inflammatory skin disease leaves patients with eczematous lesions, followed by intense itching. The approval of tralokinumab gives hope to pediatric patients with AD since this would be the first form of treatment targeting the interleukin (IL)-13 cytokine, the main source of AD symptoms. The medication was the first ever IL-13 inhibitor to receive FDA approval. The drug works by binding to IL-13 cytokines to prevent interactions with the IL-13 receptor α1 subunit of the Type 2 receptor and ultimately inhibits subsequent downstream IL-13 signaling.

The FDA approval was influenced by the eczema tralokinumab (ECZTRA) 6 trial analyzing tralokinumab’s efficacy and safety in comparison to a placebo in pediatric patients with moderate to severe atopic dermatitis between 12 and 17 years old. The randomized, double-blind, placebo-controlled, parallel-group was a multinational 52-week experiment among a total of 289 patients, 195 of whom received tralokinumab and 94 were administered placebos.

Results showed 5 times as many patients administered tralokinumab had “clear” or “almost clear” skin compared to the placebo group. The Investigator’s Global Assessment (IGA) scored 21% of patients on tralokinumab a 0 (“clear”) or 1 (“almost clear”) when compared to the 4% taking the placebo. Evaluation of the Eczema Area and Severity Index scores (EASI-75) revealed that 29% of pediatric patients taking tralokinumab achieved a 75% disease improvement, achieved by only 6% of the placebo population. Results showed that 3% of the placebo group experienced reduced itching compared with 23% of the tralokinumab group, according to scores from the Adolescent Worst Pruritis Numerical Rating Scale. Overall, the ECZTRA-6 trial demonstrated that more pediatric patients on tralokinumab experienced at least a 90% improvement in their EASI-90 scores compared with the placebo group.

Known outside of the United States as Adtralza, the prescribed subcutaneous injection is approved in adults and pediatrics in Canada, European Union, United Arab Emirates, United Kingdom, and Republic of Korea. Tralokinumab can be administered in conjunction with or without topical corticosteroids.

Common side effects of tralokinumab include upper respiratory tract infections, eye/eyelid inflammation, injection site reactions, and high white blood cell count. In potentially severe reactions, anaphylaxis presents itself in patients. The drug is not known to have beneficial effects on children under 12 years old. It is strongly suggested Adbry is not used in patients allergic to tralokinumab or any of its ingredients.

Julie Block, president and CEO of the National Eczema Association stated, “Such advances in the atopic dermatitis treatment landscape provide much-needed hope for pediatric patients seeking long-term treatment option that could work for them.”

Reference

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old. News release. FDA; October 5, 2018. Accessed November 14, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm622715.htm