FDA Approves Secukinumab for Pediatric Plaque Psoriasis

The United States 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 data from a pair of Phase 3 studies evaluating treatment in patients aged 6-18 years 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 of 162 patients with severe plaque psoriasis.

Dosage of secukinumab resulted in a reduced severity of psoriasis at week 12 compared to placebo.

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 amended 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 208-week randomized open-label study involving 84 patients with moderate to severe plaque psoriasis.

The drugs

Secukinumab is the only fully human biological agent containing interleukin-17A (IL-17A), a keystone 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 a dose of 75 mg or 150 mg, based on the patient’s weight at the time of dosing and administered by subcutaneous injection every 4 weeks after an initial loading schedule.

After initial guidance and proper training in injection technique, the treatment can be administered by an adult caregiver via a single-dose pre-filled syringe or Sensorready pen.

“Treating moderate to severe plaque psoriasis in children can be complicated as we need to balance a treatment’s ability to provide symptom relief and consider its safety profile as the top priority,” says 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 pivotal pediatric study, the majority of Cosentyx-treated patients were able to achieve clear or nearly clear skin with a safety profile consistent with previous clinical studies 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.”

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