The Food and Drug Administration (FDA) has expanded the approval of Otezla® (apremilast) to include treatment of plaque psoriasis across all severities in adults who are candidates for phototherapy or systemic therapy. Previously, the treatment was approved only for moderate to severe plaque psoriasis.

The approval was based on data from the multicenter, double-blind, placebo-controlled phase 3 ADVANCE trial (ClinicalTrials.gov Identifier: NCT03721172), which evaluated the efficacy and safety of apremilast, a phosphodiesterase 4 inhibitor, in 595 adults with mild to moderate plaque psoriasis. Patients were randomly assigned 1:1 to receive either apremilast 30mg orally twice daily or placebo for the first 16 weeks; all patients then received apremilast in an open-label extension phase through week 32. The primary endpoint was the proportion of patients with static Physician’s Global Assessment (sPGA) response of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at week 16.

Results showed that 21.6% of patients treated with apremilast achieved an sPGA response at week 16 compared with 4.1% of those who received placebo (treatment difference, 17.5%; 95% CI, 12.2-22.8). Statistically significant improvements were also observed with apremilast in key secondary endpoints, including Whole Body Itch Numeric Rating Scale response (43.2% vs 18.6% for placebo) and Scalp Physician Global Assessment response (44.0% vs 16.6% for placebo). These improvements were observed as early as week 2 and maintained through week 32.

The safety profile of apremilast was consistent with that seen in previous studies. The most common adverse reactions reported were diarrhea, headache, nausea, and nasopharyngitis.

“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. “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.”

Otezla tablets are available in 10mg, 20mg, and 30mg strengths.

References

  1. FDA approves Otezla® (apremilast) for the treatment of adult patients with plaque psoriasis, regardless of severity level. News release. Amgen. Accessed December 20, 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
  2. Otezla. Package insert. Amgen; 2021. Accessed December 20, 2021. https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/otezla/otezla_pi_english.ashx.