Amgen 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. Results 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. All patients in the study received Otezla for a 36-week extended active treatment period following the 16-week randomized placebo-controlled treatment period, providing up to 52 weeks of data.

There were 186 patients who completed the 36-week extension: 125 who continued to receive Otezla, and 61 patients switched from placebo to Otezla.  Study findings include: 56.3% of patients who received Otezla through week 52 achieved static Physician Global Assessment (sPGA) response (score of =3), an investigator assessment of overall disease severity of plaque psoriasis, the study's primary endpoint. 52.5% of patients who switched from placebo to Otezla achieved sPGA response at week 52. 71.4% of patients who received Otezla through week 52 achieved Psoriasis Area and Severity Index (PASI)-75, an investigator assessment of disease severity and skin involvement, a secondary endpoint.

75.4% of patients who switched from placebo to Otezla achieved PASI-75 at week 52. Treatment-emergent adverse events (AEs) were consistent with the known safety profile of Otezla in adults. The most common AEs (>10%) throughout the study were nausea, diarrhea, abdominal pain, vomiting and headache.

Amgen also will present late-breaking findings from a Phase 3 study evaluating the efficacy and safety of Otezla in patients with moderate to severe palmoplantar pustulosis in Japan following inadequate response to topical therapy. Palmoplantar pustulosis is a chronic inflammatory condition characterized by pustules on the palms and soles. The condition can be difficult to treat, with limited available treatment options.

The randomized, placebo-controlled, double-blind study included 176 patients who received Otezla (n=88) or placebo (n=88) for 16 weeks. All primary and secondary endpoints were met. Study findings include: 67.8% of patients who received Otezla achieved the primary endpoint of PPPASI 50 (>50% improvement in the Palmoplantar Pustulosis Area and Severity Index); this was a significantly greater response as compared to placebo (35.3%; P10%) throughout the study were diarrhea, soft feces, headache and nausea.