Amgen announces positive top-line results from Otezla phase-III Discreet study in moderate-to-severe genital psoriasis
Otezla resulted in clinically and statistically significant improvements in measures of genital psoriasis at week 16 compared with placebo
Amgen recently announced positive top-line results from the Discreet trial, a phase-III, multi-centre, randomised, 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 four-point reduction from baseline in GPI-NRS item score within the Genital Psoriasis symptoms for subjects with a baseline score of ≥ 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 two-point reduction from baseline) at week 16 with Otezla versus placebo.
“Genital psoriasis is associated with a high level of stigmatisation and burden of disease, and can be experienced in up to 63 per cent of psoriasis patients over the course of their disease. Despite the use of topical therapies for the treatment of genital psoriasis, many patients still have challenges managing their disease, prompting experts to recommend the use of systemic therapies,” said David M Reese, MD, Executive Vice President, Research and Development, Amgen.
Reese added, “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.”
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 five per cent of patients in either treatment group were diarrhoea, 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.
Detailed results from the 16-week double-blind phase of the study will be submitted for presentation at an upcoming medical conference.
In the US, Otezla is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet’s Disease. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 650,000 patients worldwide with moderate-to-severe plaque psoriasis, active psoriatic arthritis or Behçet’s Disease.