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Apremilast Now Available in US for Pediatric Plaque Psoriasis
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Amgen announces new FDA-approved oral treatment option for children and adolescents with moderate to severe plaque psoriasis.
Amgen has announced the availability of apremilast (Otezla) in the United States for pediatric use, following approval by the FDA earlier this year.1 This marks the first oral treatment option for children and adolescents aged 6 years and older with moderate to severe plaque psoriasis.
"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 a statement. "In the last decade, Otezla has been prescribed to over 1 million adults worldwide, and today's announcement represents the potential for Otezla to offer relief to many younger patients."
The FDA approval was based on results from the phase 3, multicenter, randomized, placebo-controlled, double-blind SPROUT (NCT03701763) study, which investigated the efficacy and safety of apremilast in patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy.
Earlier this year, findings from the study were presented at the 2024 American Academy of Dermatology Annual Meeting, March 8 to March 12 in San Diego, CA.2
"For the first time, we have a full year of data on a potential oral treatment for children and adolescents with moderate to severe plaque psoriasis, who currently lack any approved oral treatment options," said Loretta Fiorillo, MD, FRCPC, clinical professor of pediatrics, University of Alberta, in a statement. "At 52 weeks, more than half of patients achieved clear or almost clear skin. Otezla showed increased efficacy beyond that seen at the week 16 primary endpoint, with a durable maintenance of response – an important finding for families living with this chronic inflammatory disease."
The primary endpoint was the static Physicians Global Assessment (sPGA) score of “clear” (0) or “almost clear” (1) with at least a 2-point reduction from baseline at week 16.1 Of the patients assigned to the treatment arm of the study, 33.1% met the primary endpoint compared with only 10.8% in the placebo group (95% CI, 12.2-32.4; P < .0001).
Additionally, adverse events reported during the study were consistent with the known safety profile of apremilast in adult patients. The most common adverse events were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.
Weight loss was also observed in some patients, with body weight loss of 5% to 10% occurring in 12% of patients treated with apremilast compared with 2.5% in the placebo group. Moreover, body weight loss of 10% and more occurred in 1% of pediatric patients treated with apremilast compared with 0% with placebo, suggesting that growth (height and weight) be closely monitored in pediatric patients treated with apremilast.
The recommended dose is 20 mg twice daily for pediatric patients weighing 44 lbs to less than 110.2 lbs, and 30 mg twice daily for those who weigh at least 110.2 lbs.
"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 a statement. "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."
References
1. Otelza (apremilast) now available in the US for moderate to severe pediatric plaque psoriasis. News release. Amgen. August 20, 2024. Accessed August 20, 2024. https://www.prnewswire.com/news-releases/otezla-apremilast-now-available-in-the-us-for-moderate-to-severe-pediatric-plaque-psoriasis-302225697.html#financial-modal
2. Amgen presents new research on Otezla (apremilast) at AAD 2024. News release. Amgen. August 20, 2024. Accessed August 20, 2024. https://www.prnewswire.com/news-releases/amgen-presents-new-research-on-otezla-apremilast-at-aad-2024-302084594.html
