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Amgen Announces Positive Top-Line Results From Otezla® (apremilast) Phase 3 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 Safety and
About this update from Amgen Inc.
[{"type":"text","content":"Otezla Resulted in Clinically and Statistically Significant Improvements in Measures of Genital Psoriasis at Week 16 Compared With Placebo\n Safety and Tolerability Data Were Consistent With Known Safety Profile of Otezla\n\n\nTHOUSAND OAKS, Calif., Dec. 1, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced positive top-line results from the DISCREET trial, a Phase 3, 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. \nIn 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 ≥ 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.\n\"Genital psoriasis is associated with a high level of stigmatization and burden of disease and can be experienced in up to 63% 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, M.D., executive vice president of Research and Development at Amgen. \"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.\"\nThe type and rate of adverse events obse...