Press release
AMGEN PRESENTS NEW RESEARCH ON OTEZLA® (APREMILAST) AT AAD 2024
SPROUT 52-Week Data Demonstrate Durable Response and Consistent Safety Profile of Oral Otezla in Children with Moderate to Severe Plaque Psoriasis
About this update from Amgen Inc.
[{"type":"text","content":"SPROUT 52-Week Data Demonstrate Durable Response and Consistent Safety Profile of Oral Otezla in Children with Moderate to Severe Plaque Psoriasis\nLate-Breaking Phase 3 Study of Otezla in Palmoplantar Pustulosis Achieves Primary and Secondary Endpoints at 16 Weeks\nTHOUSAND OAKS, Calif., March 9, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new, 52-week results from the Phase 3 SPROUT study examining the use of Otezla® (apremilast) in children and adolescents aged 6 to 17 years with moderate to severe plaque psoriasis. These data, along with findings from a Phase 3 late-breaking study on Otezla in palmoplantar pustulosis, will be presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting, March 8-12 in San Diego. \n\"These data reflect Amgen's commitment to exploring new ways to treat inflammatory skin disease,\" said Ponda Motsepe-Ditshego, vice president, Global Medical, at Amgen. \"A decade after the launch of Otezla, we continue to study how this oral therapy can help improve care and reduce disease burden in underserved patient populations.\" \nSPROUT Phase 3 StudyResults from SPROUT, a multicenter, randomized, placebo-controlled, double-blind study, demonstrated 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. Continued Otezla use resulted in sustained improvements in psoriasis severity and skin involvement in patients for up to one year. The safety profile was consistent with previous Otezla studies. These findings add to the published 16-week results.1 \n\"For the first time, we have a full year of data on a potential oral treatment for children and adolescents with moderate to severe plaque psoriasis, who currently lack any approved oral treatment options,\" said Loretta Fiorillo, M.D., FRCPC, clinical professor of pediatrics, University of Alberta. \"At 52 weeks, more than half of patients achieved clear or almost clear skin. Otezla showed increased efficacy beyond that seen at the week 16 primary endpoint, with a durable maintenance of response – an important finding for families living with this chronic inflammatory disease.\" \nAll patients in the study received Otezla for a 36-week extended active treatment period following the 16-week randomized placebo-contro...