Apremilast Now Available for Pediatric Use in the US

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Amgen announced in a news release today that apremilast (Otezla; Amgen) is now available in the US for pediatric use. Earlier this year, the FDA approved apremilast for the treatment of moderate to severe plaque psoriasis in children and adolescents aged 6 years and older, who weigh at least 20 kg (44 pounds) and are candidates for phototherapy or systemic therapy. This marks a significant development for young patients with psoriasis as there are currently no other FDA-approved oral medications for the condition.¹

"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," said Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, in the 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."

The FDA approval was based on results from SPROUT (NCT03701763), a phase 3, multicenter, randomized, placebo-controlled trial that assessed apremilast’s efficacy and safety in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis. According to the release, these patients had inadequate control or intolerance to topical therapies. The primary endpoint of the trial —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—was achieved with a 33.1% response rate for apremilast compared to 10.8% for placebo (95% CI: 12.2%, 32.4%; P<0.0001). The release stated that the adverse events observed during the trial were consistent with the known safety profiles of apremilast in adults. This includes diarrhea, nausea, upper respiratory tract infections, tension headaches, and headaches.

The key study findings from SPROUT included:

• 56.3% of patients who received apremilast through week 52 achieved the study’s primary end point of a sPGA response (score of ≥3)
• 52.5% of patients who switched from placebo to apremilast achieved a sPGA response at week 52
• 71.4% of patients who received apremilast through week 52 achieved a secondary end point of Psoriasis Area and Severity Index (PASI)-75
• 75.4% of patients who switched from placebo to apremilast achieved PASI-75 at week 52²

According to the release, apremilast will be administered for pediatric patients in doses of either 20 mg or 30 mg twice daily after an initial titration period, depending on weight. The recommended dosage is 20 mg twice daily for those weighing 20 kg to less than 50 kg, and 30 mg twice daily for those weighing 50 kg or more.

"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," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen, in the 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."

Amgen stated they are committed to supporting plaque psoriasis patients to ensure that appropriate patients have affordable access to apremilast. For more information, interested parties can visit Otezla.com.

Apremilast is also indicated for the treatment of:

• Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
• Pediatric patients aged 6 years and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• Adult patients with active psoriatic arthritis
• Adult patients with oral ulcers associated with Behçet's Disease

References

1. Otezla (apremilast) now available in the US for moderate to severe pediatric plaque psoriasis. Amgen. August 20, 2024. Accessed August 20, 2024. https://investors.amgen.com/news-releases/news-release-details/otezlar-apremilast-now-available-us-moderate-severe-pediatric 
2. Bader K. Apremilast demonstrates consistent safety and efficacy in children with moderate to severe plaque psoriasis at 52 weeks. Dermatology Times. April 9, 2024. Accessed August 20, 2024. https://www.dermatologytimes.com/view/apremilast-demonstrates-consistent-safety-and-efficacy-in-children-with-moderate-to-severe-plaque-psoriasis-at-52-weeks