Amgen’s Otezla Shines Again in Psoriasis

Amgen’s oral drug candidate for genital psoriasis delivered positive topline results from its Phase III trial, with both primary and secondary endpoints met.

DISCREET, a multi-center, randomized, double-blind, placebo-controlled study, evaluated the efficacy of Otezla (apremilast) in adults who have been diagnosed with moderate to severe plaque psoriasis and moderate to severe genital psoriasis. Some of the 289 participants were given 30 mg of Otezla twice a day, while the others received a placebo drug for 16 weeks. After which, all the participants either switched or continued using the medicine up to the 32nd week.

Success in moderate to severe plaque psoriasis was defined as having a static Physicians Global Assessment of Genitalia (sPGA-G) score of ≥ 3, while it meant a modified sPGA-G score of ≥ 3 for moderate to severe genital psoriasis. The study is still ongoing and is expected to be completed by the first half of 2022.

As of week 16, the trial demonstrated a statistically significant improvement versus the placebo, achieving its primary endpoint of a modified static sPGA-G response of clear (0) or almost clear (1), with at least a two-point reduction from the baseline. Its secondary endpoints were also met, namely a significant improvement in the Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response (at least a four-point reduction from baseline and a score of ≥ 4), a change in the Dermatology Life Quality Index, a change in the affected body surface area (BSA), and an sPGA response of clear or almost clear, with least a two-point drop from the baseline.

Adverse events were observed consistent with Otezla’s profile and affected around 5% of the participants who reported nausea, diarrhea, nasopharyngitis and headache.

“The results from the DISCREET trial further add to the growing body of evidence on the safety and effectiveness of Otezla in moderate to severe plaque psoriasis, including manifestations with high unmet medical needs, such as genital psoriasis,” said David M. Reese, M.D., executive vice president of research and development at Amgen, in a statement.

Psoriasis is a chronic and serious inflammatory disease that causes red, raised and scaly patches on the skin. Around 125 million people are diagnosed with it worldwide, with more than 7.5 million living in the U.S. Around 80% of people living with psoriasis have plaque psoriasis, while some 63% also have the disease in the genital area at some point during its course.

In the U.S., Otezla has already been approved since 2014 for the treatment of adults with moderate to severe plaque psoriasis and is the candidate for systemic therapy or phototherapy. It is also indicated for use in adults with oral ulcers linked with Behçet’s disease and those with active psoriatic arthritis. Amgen will present these week-16 results at an upcoming medical conference that’s yet to be announced.