Positive new data from Otezla studies, SPROUT ,for pediatric plaque psoriasis and DISCREET for genital psoriasis

SPROUT study in pediatric moderate to severe plaque psoriasis: The SPROUT study 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 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<0.0001). the major secondary endpoint was also met: a greater proportion of patients achieving a 75% or more reduction in the psoriasis area and severity index (pasi 75) score, with 45.4% for otezla versus 16.1% for placebo (95% ci: 17.8%, 40.9%; p><0.0001).the adverse events were consistent with the known safety profile of otezla. the most commonly reported (in at least 5% of patients) adverse events were diarrhea (20.2%), nausea (19.6%), abdominal pain (19.6%), vomiting (17.8%), headache (10.4%), pyrexia (6.7%), nasopharyngitis (6.1%) and upper abdominal pain (5.5%).

"The SPROUT data are extremely encouraging and could provide a valuable new alternative option for children, who currently only have access to a few therapeutic options that have been studied and approved to treat moderate-to-severe pediatric plaque psoriasis," said Anna Belloni Fortina, MD, co-author of the study and Head of the Pediatric Dermatology Unit, Department of Medicine, University of Padua Medical School. "We are grateful to the patients, families and clinicians who have contributed to this study as we look to deliver a new therapeutic option for children with unmet need in moderate to severe plaque psoriasis."

DISCREET study in moderate to severe genital psoriasis. 16-week data from the DISCREET study in adult patients with moderate to severe genital psoriasis, demonstrated a clinically meaningful and statistically significant improvement in genital psoriasis, with twice as many patients achieving the primary endpoint of a clear (0) or almost clear (1) score on the Physician Global Assessment of Genitalia (sPGA-G) scale when receiving Otezla, when compared with placebo (38.7% for Otezla versus 19.1% for placebo; P = 0.0003). The secondary endpoints of the study were also met. The data showed improvements in sPGA response, with 21.5% responding for Otezla versus 7.2% for placebo (95% CI: 6.0, 22.5; P = 0.0007), and Genital Psoriasis Itch Numeric Rating Scale response (GPI-NRS), at 46.0% for Otezla versus 19.6% for placebo (95% CI: 14.5, 38.0; P < 0.0001).

Additionally, data showed greater reduction in affected body surface area (BSA), with a 4.12% mean reduction with Otezla versus 0.79% with placebo (95% CI: -5.18, -1.47; P = 0.0005); a Dermatology Life Quality Index (DLQI) burden score reduction of 5.3 for Otezla versus 2.6 for placebo (95% CI: -4.2, -1.1; P = 0.0008); a Genital Psoriasis Symptoms Scale (GPSS) reduction in mean score of 20.5 for Otezla versus 5.3 for placebo (95% CI: -20.3, -10.0; P < 0.0001); and a reported improvement in sexual health impacted by psoriasis with Otezla. The adverse events were consistent with the known safety profile of Otezla, with the most commonly reported (in at least 5% of patients) in either treatment group being diarrhea, headache, nausea and nasopharyngitis.