Secukinumab (Cosentyx, Novartis) has received FDA approval for the treatment of children and adolescents with moderate to severe plaque psoriasis.
The FDA has approved secukinumab (Cosentyx, Norvartis) for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are also candidates for systemic therapy or phototherapy.1
The is the first approval from the FDA that secukinumab has received to treat pediatric patients. There are 5 years of adult data showing the long-term efficacy and a consistent safety profile for treatment of moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing.
“Treating moderate to severe plaque psoriasis in children can be complicated, as we need to balance the ability of a treatment to provide symptom relief while considering the safety profile as the top priority,” said John Browning, MD, FAAD, FAAP, MBA, clinical trial investigator, adjunct associate professor of pediatrics and dermatology at the University of Texas Health, San Antonio, Texas. “In the pediatric pivotal study, the majority of patients treated with Cosentyx were able to achieve clear or almost clear skin with a safety profile consistent with previous clinical trials in adults. Due to the systemic nature of the disease, Cosentyx is a welcome addition as a treatment option for families dealing with this challenging condition.”
The approved dosing for secukinumab is 75 mg or 150 mg depending on patient weight and is administered by skin injection every 4 weeks after initial dose. Once trained by the physician and given proper counseling, an adult caregiver can administer dosage.
“The impact of psoriasis on children is much deeper than skin and can potentially lead to life course impairment. Today’s FDA approval further demonstrates our commitment to reimagine medicine for pediatric plaque psoriasis patients,” said Angelika Jahreis MD, PhD, global head development unit immunology, hepatology & dermatology at Novartis, Basel, Switzerland..“With more than 400,000 patients treated in over 100 countries worldwide, we continue to build on the established safety and efficacy profile of Cosentyx, with plans to expand to 10 indications over the next 10 years.”
The approval is based on 2 phase 3 studies that demonstrated both low-dose and high-dose secukinumab were effective and safe.
In the first study, which was a 52 week randomized, double-blind, placebo- and active-controlled trial, data showed secukinumab reduced psoriasis severity at week 12 compared with placebo. Psoriasis Area Severity Index (PASI) 75 response 55% of patients dosed at 75 mg vs 10% placebo and 86% of patients dosed at 150 mg vs 19%. In total, 70% total secukinumab patients vs 15% placebo total achieved PASI 75. The Investigator’s Global Assessment modified 2011 (IGA) skin response showed that 32% of the patients in the 75 mg secukinumab treatment arm and 81% of the 150 mg treatment arm achieved IGA 0/1.1
The second phase 3 study’s, a randomized open-label, 208-week trial, primary objective was safety was of 84 subjects six years of age and older with moderate to severe plaque psoriasis.
“Living with psoriasis is challenging, and can be highly stressful for children and adolescents,” said Randy Beranek, president and CEO, National Psoriasis Foundation, Portland, Oregon. “Having expanded treatment options for this patient population is a step in the right direction to help reduce the burden of plaque psoriasis.”
1. Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2021.