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The phase III DISCREET trial of Otezla achieves meaningful improvements in moderate to severe genital psoriasis and moderate to severe plaque psoriasis.

Read time: 1 mins
Published:2nd Dec 2021
Amgen announced positive top-line results from the DISCREET trial, a Phase III, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis.

The study showed that oral Otezla 30 mg twice daily achieved a clinically meaningful and statistically significant improvement, compared with placebo, in the primary endpoint of the modified static Physician's Global Assessment of Genitalia (sPGA-G) response (defined as an sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16.

In addition, all secondary endpoints were also met with meaningful and significant improvements in Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response (defined as at least a 4-point reduction from baseline in GPI-NRS item score within the Genital Psoriasis Symptoms for subjects with a baseline score of at least 4); affected body surface area (BSA) change from baseline; Dermatology Life Quality Index (DLQI) change from baseline; and static Physician's Global Assessment (sPGA) response (defined as sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16 with Otezla versus placebo.

The type and rate of adverse events observed in this trial were consistent with the known safety profile of Otezla. The most commonly reported adverse events that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea and nasopharyngitis. Patients completing the double-blind phase of the trial 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.

Condition: Psoriasis
Type: drug

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