FDA Approves Apremilast for Plaque Psoriasis, Regardless of Severity Level


The drug is the first and only oral therapy approved for the treatment of adult patients who are candidates for either phototherapy or systemic therapy.

The FDA has approved apremilast (Otezla, Amgen) for adult patients with plaque psoriasis who are candidates for either phototherapy or systemic therapy.

With approximately 8 million individuals diagnosed with plaque psoriasis in the United States, 5 million of whom have mild to moderate disease, this expanded indication for apremilast makes it the first and only oral treatment approved for adult patients with plaque psoriasis at all severity levels.

"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," David M. Reese, MD, executive vice president of research and development at Amgen, said in a statement.

"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,” he said.

The FDA approval is based on the results from the phase 3 ADVANCE trial assessing response in patients with mild to moderate plaque psoriasis. During this trial, 5 times as many adults with mild to moderate plaque psoriasis administered apremilast at 30 mg twice daily were found to achieve the primary endpoint of the Static Physician's Global Assessment (sPGA) response at week 16 compared with those in the placebo group (21.6% versus 4.1%, p<0.0001).

Apremilast also was found to show statistically significant improvements in key symptom assessment areas, such as the Scalp Physician's Global Assessment (ScPGA) response (44% versus 16.6%) and the Whole Body Itch Numeric Rating Scale (NRS) response (43.2% versus 18.6%), at week 16 compared with the placebo. As early as week 2, the investigators observed these improvements in the ScPGA, sPGA response, and Whole Body Itch NRS responses, with these improvements maintained through week 32.

During the trial, investigators observed adverse events (AEs) in patients that were consistent with the known safety profile of apremilast. Specifically, the most common treatment-emergent AEs (≥5%) were diarrhea, headache, nasopharyngitis, and nausea.

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

Following this expanded indication, apremilast has been approved for 3 indications in the United States that include adult patients with active psoriatic arthritis, adult patients with oral ulcers associated with Behçet disease, and adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Although treatment advancements have been made in recent years, patients with plaque psoriasis continue to have a significant unmet need, particularly among those with mild to moderate plaque psoriasis or among those who experience persistent symptoms even after administering a topical treatment.

"Plaque psoriasis often affects patients more severely than can be measured by Body Surface Area 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,” Stacie Bell, PhD, chief scientific and medical officer at the National Psoriasis Foundation, said in the statement. "It's welcome news to finally have an oral systemic option with a well-established safety profile available for all adult plaque psoriasis patients."


FDA approves Otexla® (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of severity level. Amgen. News release. December 20, 2021. Accessed December 22, 2021.


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