FDA Approves Apremilast for All Psoriasis Severities

With this expanded indication, apremilast (Otezla; Amgen) is now the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate, and severe.

Amgen announced that the FDA has approved apremilast (Otezla; Amgen) for the treatment of patients 18 and older with plaque psoriasis who are candidates for phototherapy or systemic therapy.1 With this news, apremilast became the first and only oral drug approved in adult patients with plaque psoriasis across all severities, including mild, moderate, and severe, according to the release.

"Plaque psoriasis can place a significant burden on the lives of patients, regardless of the severity of skin involvement. A substantial unmet need remains for mild to moderate plaque psoriasis patients for whom topical therapies may not be sufficient, especially for those with difficult-to-treat areas, like the scalp," said David M. Reese, MD, executive vice president of research and development at Amgen, Ventura County, California. "With this expanded indication for Otezla, patients across all levels of disease severity now have an oral, systemic option that has already been used by more than 650,000 people worldwide and has no lab monitoring requirement."

"Given that psoriasis is a systemic inflammatory disease, some patients may need more than surface level relief," said Linda Stein Gold, director of Dermatology Clinical Research at Henry Ford Health System, Detroit, Michigan and ADVANCE study investigator. "For the first time, dermatologists can offer patients struggling with plaque psoriasis of any degree an effective oral treatment with an established safety profile."

The FDA approval is based on findings from the Phase 3 ADVANCE trial (NCT03721172), in which 5 times as many adults with mild to moderate plaque psoriasis receiving oral apremilast 30 mg twice daily achieved the primary endpoint of Static Physician's Global Assessment (sPGA) response at week 16 compared to placebo (21.6% versus 4.1%, p<.0001), the release explains. Also, it was demonstrated that apremilast had statistically significant improvements in key symptoms, such as Whole Body Itch NRS response (43.2% versus 18.6%), and a difficult-to-treat area, the scalp, measured by Scalp Physician's Global Assessment (ScPGA) response (44% versus 16.6%), at week 16 compared to placebo, the release continued. Improvements in sPGA response, Whole Body Itch NRS and ScPGA response were observed as early as week 2 and maintained through week 32.1

The adverse events (AEs) observed in the trial were consistent with the known safety profile with the most reported (greater than 5%) treatment-emergent AEs with apremilast treatment were diarrhea, headache, nausea and nasopharyngitis.

"Plaque psoriasis often affects patients more severely than can be measured by Body Surface Area (BSA) alone, particularly for those with manifestations in difficult-to-treat areas like the scalp. The location of plaques may make the area sensitive to topical treatments or challenging to apply them," said Stacie Bell, PhD, chief scientific and medical officer at the National Psoriasis Foundation, Denver, Colorado. "It's welcome news to finally have an oral systemic option with a well-established safety profile available for all adult plaque psoriasis patients."

Reference:

1. FDA approves Otezla (Apremilast) for the treatment of adult patients with plaque psoriasis, regardless of severity level. Published December 21, 2021. Accessed December 23, 2021. https://www.prnewswire.com/news-releases/fda-approves-otezla-apremilast-for-the-treatment-of-adult-patients-with-plaque-psoriasis-regardless-of-severity-level-301448542.html