FDA expands indication for tralokinumab to adolescents with atopic dermatitis
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Key takeaways:
- The FDA expanded an indication for tralokinumab to include children aged 12 to 17 years with atopic dermatitis.
- Trial data show the safety profile in children was comparable to adults.
The FDA approved an expanded indication for tralokinumab-ldrm to include children aged 12 to 17 years with moderate to severe atopic dermatitis not adequately controlled with topical therapies, according to a press release from Leo Pharma.
Tralokinumab-ldrm (Adbry) is the first and only FDA-approved biologic that specifically binds to and inhibits the interleukin-13 cytokine, one of the key drivers of AD signs and symptoms, according to the release. The FDA first approved tralokinumab-lrdm in May 2021.
"This is an important milestone on our path towards making a fundamental difference for those who need it most,” Brian Hilberdink, president, region North America, LEO Pharma, said in the release. “This critical patient group now has access to a much-needed additional treatment option to manage their atopic dermatitis. We are delighted to be able to offer Adbry, a highly targeted treatment, to both adult and pediatric patients in the U.S. This debilitating disease can have a particularly strong impact on pediatric patients, who often feel socially isolated because of their condition. We are incredibly proud of the progress we have made to date, and we will continue to work hard to address unmet needs in additional patient populations.”
An initial loading dose of 300 mg, followed by a 150 mg dose every 2 weeks, is approved for children aged 12 to 17 years.
The approval is based on data from the phase 3 ECZTRA 6 trial. As Healio previously reported, the trial demonstrated tralokinumab at doses of 150 mg or 300 mg was associated with improvements compared with placebo in a number of efficacy outcomes at 16 weeks and 52 weeks in adolescents with moderate to severe atopic dermatitis.
Of the 289 patients included in the final analysis, 98 received tralokinumab 150 mg, 97 received tralokinumab 300 mg and 94 received placebo. The median age of the patients was 15 years, and 51.6% of participants were boys.
At 16 weeks, 21.4% of patients in the low-dose tralokinumab group reached an IGA score of 0 or 1 without rescue medication, while 17.5% of patients in the high-dose group reached this endpoint compared with 4.3% in the placebo group (P < .001 for 150 mg; P = .002 for 300 mg).
For the EASI 75 endpoint, 28.6% of patients in the tralokinumab 150 mg group reached this outcome without rescue medication compared with 6.4% in the placebo group (P < .001). Similarly, 27.8% of patients in the tralokinumab 300 mg group reached and Eczema Area and Severity Index score of 75 (P < .001).
Overall, positive results were reported for key secondary endpoints involving Adolescent Worst Pruritus Numeric Rating Scale, SCORing AD and Children’s Dermatology Life Quality Index.
Findings from 52 weeks showed that tralokinumab efficacy persisted in more than half of patients who met the primary endpoints at week 16.
The safety of Adbry, assessed through the initial treatment period of 16 weeks and the long-term period of 52 weeks, was comparable to the safety profile from trials in adults with atopic dermatitis. In the ECZTRA 1, 2, and ECZTRA 3 adult trials, the most common adverse events (incidence 1%) were upper respiratory tract infections (mainly reported as the common cold), conjunctivitis, injection site reactions and eosinophilia.
“We know the symptoms associated with moderate-to-severe atopic dermatitis can have an impact on pediatric patients, which is why it’s so important to have treatment options with demonstrated efficacy in itch reduction and skin clearance,” Amy Paller, MD, chair of the department of dermatology at Northwestern University Feinberg School of Medicine and the international coordinating investigator for ECZTRA 6, said in the release. “Clinical trial results that provide this evidence are invaluable to clinicians evaluating the safety and efficacy of treatment options for their pediatric patients.”