Apremilast (Otezla, Amgen) is now available in the U.S. for pediatric use. Earlier this year, the U.S. Food and Drug Administration (FDA) approved apremilast for the treatment of moderate to severe plaque psoriasis in children and adolescents ages 6 and older who weigh at least 20 kg (44 lb) and are candidates for phototherapy or systemic therapy.
There are currently no other FDA-approved oral medications for moderate to severe plaque psoriasis in this patient population.
The FDA approval was based on results from SPROUT, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study which investigated the efficacy and safety of Otezla in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. The primary endpoint – static Physician’s Global Assessment (sPGA) response (defined as an sPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline) – at week 16 was met with a 33.1% sPGA response for Otezla versus 10.8% for placebo. The adverse events were consistent with the known safety profile of Otezla in adult patients.
The most common side effects of Otezla include diarrhea, nausea, upper respiratory tract infection, tension headache and headache.
After the initial titration period, the maintenance dosage of Otezla in this patient group will be administered in either 20 or 30 mg doses, based on weight, twice daily. The recommended dose is 20 mg twice daily for pediatric patients weighing 20 kg to <50 kg, and 30 mg twice daily for those who weigh at least 50 kg.
“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,” says Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, 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.”
Amgen is committed to supporting plaque psoriasis patients to ensure that appropriate patients have affordable access to Otezla. For more information, visit Otezla.com.
