SPROUT Data Show Otezla Resulted in Significant Improvements in Measures of Moderate to Severe Plaque Psoriasis at Week 16 Compared With Placebo in Children Ages 6-171
DISCREET 16-week Data Demonstrated Statistically Significant Improvements in Genital Psoriasis, Including Skin, Itch and Quality of Life, in Patients With Moderate to Severe Disease2
Adverse Events Were Consistent With Known Safety Profile of Otezla in Both Studies
THOUSAND OAKS, Calif., Sept. 8, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced results from two significant Phase 3 clinical studies of oral Otezla® (apremilast), demonstrating efficacy in pediatric patients with moderate to severe plaque psoriasis and in adults with moderate to severe genital psoriasis, at the 31st European Academy of Dermatology and Venereology (EADV) Congress, taking place in Milan, Italy, Sept. 7-10, 2022.
SPROUT study in pediatric moderate to severe plaque psoriasis
The SPROUT study1 investigated the efficacy and safety of Otezla in pediatric patients aged 6 to 17 years with moderate to severe plaque psoriasis inadequately controlled by or intolerant to topical therapy. The primary endpoint of the static Physician's Global Assessment (sPGA) response (defined as an sPGA score of clear [0] or almost clear [1] with at least a 2-point reduction from baseline) at week 16 was met with a 33.1% sPGA response for Otezla versus 11.5% for placebo (95% CI: 11.2%, 32.1%; P