Since around one third of psoriasis patients in the U.S. first develop the disease in childhood or adolescence, there is a need to find safe and effective treatment for children with the disease. Currently pediatric patients with mild-to-moderate psoriasis are treated with topical steroids and phototherapy. In severe cases, systemic agents may be used off-label, but can often be associated with serious adverse events.
A phase 2 multicentered open label trial recently published in the Journal of the American Academy of Dermatology examined the safety of apremilast use in children with psoriasis. The study was led by Amy Paller, M.D., at Northwestern University and was funded by Celgene.
Children between the ages of 6-17 were enrolled in the study. To be included, patients needed to have moderate-to-severe plaque psoriasis (PASI>12, BSA >10%, sPGA >3). In addition, participants had to fail conventional therapy with topical steroids and phototherapy.
Participants recruited from the U.S., Canada and Europe received apremilast for 52 weeks with a one year follow up period. Patients above 70 kg received the adult dosing of 30 mg two times per day. Children less than 70 kg received a reduced dose of 20 mg two times per day.
Paller, Amy S., et al. "Pharmacokinetics and Safety of Apremilast in Pediatric Patients With Moderate to Severe Plaque Psoriasis: Results From a Phase 2 Open-Label Study." Journal of the American Academy of Dermatology. 2019.