Otezla for Treatment of Pediatric Plaque Psoriasis Now Available in US
The approval of apremilast to treat plaque psoriasis in children and adolescents aged 6 years and older was based on data from the phase 3 SPROUT trial.
Apremilast (Otezla) for the treatment of moderate to severe plaque psoriasis in children and adolescents aged 6 years and older who weigh at least 44 pounds is now available for use in the United States, biotechnology company Amgen announced in a release.1 The treatment is intended for patients who are candidates for phototherapy or systemic therapy.
Otezla for Treatment of Pediatric Plaque Psoriasis Now Available in US / MichaelVi - stock.adobe.com
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate, although the specific mechanisms by which it exerts its therapeutic action are not completely understood. The therapy, which was initially approved in 2014 for the treatment of active psoriatic arthritis in adults, received FDA approval for the new indication in April 2024.2
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"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,” Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, said in a release.1 “However, treatment options for this chronic immune-mediated disease are limited. 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."
The approval of apremilast to treat plaque psoriasis in children and adolescents was based on data from the SPROUT (NCT03701763) trial. SPROUT was a multicenter, randomized, placebo-controlled, double-blind phase 3 study that evaluated the efficacy and safety of apremilast in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy.
The primary study endpoint was the percentage of patients with a Static Physician Global Assessment (sPGA) response at week 16. Key secondary endpoints included the percentage of patients who achieved at least a 75% reduction in Psoriasis Area Severity Index (PASI-75) from baseline to week 16, percentage of patients who achieved at least a 50% reduction in PASI-50 from baseline to week 16, and percentage change from baseline in total PASI score at week 16.
The study cohort included 245 patients who randomly received either apremilast or placebo for 16 weeks. All of the patients then received the therapy during a 36 week extension phase for a total of 52 weeks. The patients who received apremilast were given either 20 mg or 30 mg twice daily depending on weight. Of the 245 initial patients, 221 completed the double blind phase portion of the study.3
Investigators found that 56.3% of patients who received apremilast through week 52 achieved sPGA response, and 52.5% of patients who switched from placebo to apremilast achieved sPGA response at week 52. Additionally, 71.4% of patients who received the therapy through week 52 achieved PASI-75, and 75.4% of patients who switched from placebo achieved PASI-75 at week 52.4
The safety profile of apremilast in children and adolescents was consistent with what has been seen in adult patients. The most common adverse events were nausea, diarrhea, abdominal pain, vomiting, and headache.4
"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 release.1 "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."
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