Amgen Announces Positive Top-Line Results from Phase 3 DISCREET Study of Otezla (apremilast) in Psoriasis

Amgen Announces Positive Top-Line Results from Phase 3 DISCREET Study of Otezla (apremilast) in Psoriasis

Amgen announced the phase 3 DISCREET trial, which evaluated Otezla (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis, reached clinically and statistically significant improvements in measures of genital psoriasis at week 16 compared with placebo. In addition, all secondary endpoints were also met with meaningful and significant improvements. 

The multicenter, randomized, placebo-controlled, double-blind DISCREET enrolled 289 patients with moderate to severe genital psoriasis (defined as modified sPGA-G score ≥ 3). Patients also had moderate to severe plaque psoriasis (sPGA score ≥ 3) with BSA involvement ≥ 1% in a non-genital area and had an inadequate response or intolerance to topical therapy for psoriasis affecting the genital area. Otezla 30 mg twice daily or placebo was administered for the first 16 weeks. Following the 16-week placebo-controlled, double-blind phase of the trial, patients continued or switched to Otezla during the extension phase of the study and will be treated through week 32. The study is ongoing and is planned to complete in the first half of 2022.

Data showed that oral Otezla 30 mg twice daily ...

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