Pediatric patients weighing 20 kg to <50 kg should take 20 mg of apremilast twice daily and children weighing at least 50 kg should take 30 mg twice daily.
Apremilast (Otezla; Amgen Inc) is currently available in the US for the treatment of moderate to severe plaque psoriasis among children and adolescents aged 6 to 17 years following its FDA approval that was granted earlier this year. The approval marked apremilast as the first approved medication to treat this patient population, according to study authors.1
Psoriasis impacts around 125 million individuals worldwide as a chronic disease that causes skin cells to build up quickly, resulting in red, discolored, scaly and itchy patches on the skin. However, about 80% of individuals with psoriasis have plaque psoriasis and one-third of those individuals are under 18 years old, according to study authors.1 Individuals with a mild to moderate form of the disease often experience more localized plaques that can be treated with topical corticosteroids as individuals with moderate to severe disease are commonly treated with systemic medications.2 While the trigger is unknown, certain foods, drinks, prescription medications, dry skin, and emotion stress can contribute to a flare-up.3
"Children living with moderate to severe plaque psoriasis often experience uncomfortable and highly visible symptoms, such as itchy, dry lesions that may bleed or cause pain. However, treatment options for this chronic immune-mediated disease are limited," Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, said in a news release. "Until now, FDA-approved systemic treatment options for youth have been injections or infusions. The addition of an oral treatment option with a well-established safety profile is great news for children with this disease and their families."1
Trial Name: Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT03701763
Sponsor: Amgen
Completion Date: March 2023
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4, specific for cyclic adenosine monophosphate, according to study authors. The approval for apremilast was based on findings from the phase 3 multicenter, randomized, placebo-controlled, double-blind SPROUT (NCT03701763) study that assessed the efficacy and safety of the drug among pediatrics with moderate to severe plaque psoriasis.1
The study authors noted that the primary endpoint of static Physician's Global Assessment (sPGA)was met at week 16 with a 33.1% sPGA response for apremilast, compared to 10.8% for the placebo.1
"For the first time, children and adolescents with moderate to severe plaque psoriasis and their caregivers have an oral option to treat this chronic disease, with its highly visible, uncomfortable symptoms," Murdo Gordon, executive vice president of Global Commercial Operations at Amgen, said in a news release. "In the last decade, Otezla has been prescribed to over one million adults worldwide, and today's announcement represents the potential for Otezla to offer relief to many younger patients."1
Adverse events (AEs) for apremilast were constant with the known safety profile for adults treated with the drug. However, the most common AEs reported were diarrhea, nausea, upper respiratory tract infection, tension headache and headache.1
The study authors noted that pediatric patients that weigh 20 kg to <50 kg should take 20 mg of apremilast twice daily and children who weigh at least 50 kg should take 30 mg twice daily.1
