The FDA has approved secukinumab to treat patients over the age of 6 who have moderate to severe plaque psoriasis and are eligible for systemic therapy or phototherapy, according to a release from the manufacturer.
The approval follows five years of adult data showing the treatment provides long-lasting efficacy and a reliable safety profile for patients with moderate to severe psoriasis, psoriatic arthritis, and ankylosing spondylitis. The approval was based on results of two phase 3 studies evaluating children between the ages of 6 and 18 with plaque psoriasis.
A 52-week study evaluating the safety and efficacy of secukinumab included 162 patients with severe plaque psoriasis. Data from the trial showed the treatment reduced psoriasis severity at week 12 compared with placebo in several key endpoints, including PASI 75 response: 55% for patients treated with 75 mg vs. 10% on placebo and 86% on the 150 mg dose vs. 19% on placebo. Overall, 70% of all the patients treated with secukinumab achieved “clear” or “almost clear” skin response on the Investigator’s Global Assessment, compared to 15% of all the patients on placebo.
The second phase 3 study, which included 84 patients over the age of six, assessed the safety of the treatment, with the release noting the findings were similar to what has been seen with adult patients.
“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 clinical trial investigator John Browning, MD, MBA, FAAD, FAAP, of Texas Dermatology. “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 approval includes doses of 75 mg or 150 mg depending on the child’s weight at the time of the dosing. The treatment is administered by a subcutaneous injection every four weeks after an initial loading regimen. It can be given to the patient by an adult caregiver without the need to go to a provider’s office.