FDA Approves Secukinumab for Pediatric Plaque Psoriasis

The US Food and Drug Administration (FDA) has approved secukinumab (Cosentyx) as a treatment for moderate to severe plaque psoriasis in pediatric patients at least 6 years old who are candidates for systemic therapy or phototherapy.

The approval, awarded to Novartis, was based on the data from a pair of phase 3 studies evaluating the treatment in patients between 6-18 years old with plaque psoriasis.

The Studies

In the first study, researchers tested the treatment in a 52-week, randomized, double-blind, placebo- and active-controlled study involving 162 patients with severe plaque psoriasis.

Secukinumab dosing resulted in reduced psoriasis severity at week 12 compared to placebo.

The treatment ultimately resulted in improvements in Psoriasis Area Severity Index (PASI) 75 response (55% 75 mg vs 10% placebo, 86% 150 mg vs 19% placebo, 70% total secukinumab vs 15% total placebo and Investigator’s Global Assessment modified 2011 (IGA) “clear” or “almost clear” skin response (32% 75 mg vs 5% placebo, 81% 150 mg vs 5% placebo, 56% total secukinumab vs 5% total placebo), co-primary endpoints of the study.

In the second study, the researchers conducted a randomized open-label, 208-week trial involving 84 patients with moderate to severe plaque psoriasis.

The Drug

Secukinumab is the only fully human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

The indication is for 75 mg or 150 mg dosing, based on the patient’s weight at the time of dosing and is administered by subcutaneous injection every 4 weeks after an initial loading regimen.

Following initial counseling and proper training in injection technique, the treatment can be administered by an adult caregiver through a single-dose prefilled syringe or Sensoready pen.

“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, in a statement. “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.”