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Taltz® Receives Pediatric Indication

FDA Approves Taltz® for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

Every year, roughly 20,000 children under 10 years of age are diagnosed with psoriasis.[1] Despite that, there remains an unmet need for pediatric psoriasis treatments. However, a new biologic treatment option is on the horizon. On March 30, 2020, the U.S. Food and Drug Administration approved the use of Taltz® (ixekizumab) for use in pediatric patients, six years of age or older, with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy.

Taltz®, manufactured by Eli Lilly, acts by binding with a substance involved in normal inflammatory and immune responses (interleukin 17A cytokine), which is produced by T helper 17 cells (Th17, a type of immune cell), and preventing the interaction with its receptor. This action helps to stop the release of substances which can cause inflammation.[2]

“One percent of all children have psoriasis and up to about 1/4 of these are moderate to severe and require more than topical medications. Research has shown that the Th17 pathway is critical to psoriasis pathogenesis, and the Th17 pathway inhibitors have been superior in efficacy for skin disease to the TNF inhibitors in adults. This is the first study showing the efficacy of a Th17 inhibitor in the pediatric population, and indicated outstanding results for pediatric patients with moderate to severe psoriasis,” said Amy Paller, M.D., the chair of the dermatology department at Northwestern University.

In the phase 3 study, the patients, aged 6 years to younger than 18 years, were randomized to receive Taltz® (dosing was 20, 40 or 80 mg based on weight) or placebo. After 12 weeks, 89 percent of patients treated with Taltz® achieved PASI 75 (Psoriasis Area and Severity Index score) compared to 25 percent for patients who were treated with placebo. Additionally, 81 percent of patients achieved sPGA (static Physician's Global Assessment) 0,1 compared to 11 percent for patients treated with placebo.[2] 

“The approval for ixekizumab in the U.S. now provides the third approved biologic for pediatrics and only the fourth for children under the age of 12. In addition, having the backing of a large clinical trial, this helps tremendously knowing appropriate dosing guidelines. It's very exciting, as a pediatric dermatologist, to know that I may have access to a medication for my patients that can get them clear and works quickly as well as an option for patients that may have failed other treatment modalities. I hope this is a sign of further expansion of our pediatric psoriasis treatment options,” said Lara Wine Lee, M.D., a pediatric dermatologist at the Medical University of South Carolina in Charleston.

The Eli Lilly drug was previously approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as adults with active psoriatic arthritis and active ankylosing spondylitis.[2]

The National Psoriasis Foundation (NPF) is proud to be a driving force in psoriatic disease research and patient advocacy to aid in improving the health of those living with psoriatic disease. In 2016, NPF rallied patients to be heard at the FDA’s Patient-Focused Drug Development Initiative meeting about psoriasis. Over 200 people responded to the call and shared stories about the impact psoriasis had on their lives, the significant burden on daily life and about their experiences with various treatment options. One of the many reasons this meeting was exceptional was because it highlighted the unmet medical need for more treatments for pediatric patients living with psoriasis, which highlights why this new indication is so important.

Have questions about psoriatic disease treatment options? NPF’s Patient Navigation Center is available to anyone impacted by psoriatic disease to help answer questions and find solutions so patients can live their healthiest life.

Disclosure: Dr. Wine Lee was an investigator and member of the advisory board for ixekizumab for pediatric psoriasis. She was paid for these activities.   

[1] https://www.psoriasis.org/parents/about-psoriasis

[2] https://investor.lilly.com/news-releases/news-release-details/lillys-taltzr-ixekizumab-receives-us-fda-approval-treatment-1

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