Positive results for Taltz in pediatric patients with moderate to severe plaque psoriasis.- Eli Lilly

Eli Lilly and Company announced that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase III study in pediatric patients with moderate to severe plaque psoriasis , demonstrating that 89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area and Severity Index score (PASI 75) and 81 percent of patients treated with Taltz achieved a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1). Results of the study are being presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.

Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis. The co-primary endpoints of the study were the proportion of patients achieving a significant 75 percent improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1) at Week 12. Key secondary endpoints included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at Week 12, and at least a four-point improvement in Itch Numeric Rating Scale (Itch NRS greater than 4) among patients with baseline Itch NRS greater than 4 at Week 12, as well as PASI 75 and sPGA 0,1 at Week 4. The proportion of patients achieving 0 or 1 on the Children's Dermatology Life Quality Index (CDLQI, patients 6 to 16 years old) or DLQI (patients greater than 17 years old) at Week 12 was also evaluated.

A total of 201 patients aged 6 to less than 18 years of age with moderate to severe plaque psoriasis were randomized to receive Taltz (20 mg for <25 kg 40 mg for 25-50 kg or 80 mg for>50 kg through Week 12, with 40 mg, 80 mg or 160 mg starting doses, respectively) or placebo. At 12 weeks, the proportion of patients achieving the co-primary endpoints was superior to placebo with statistically significant difference (P<0.001), including: 89 percent of patients treated with taltz achieved pasi 75 compared to 25 percent of patients treated with placebo. 81 percent of patients treated with taltz achieved spga 01 compared to 11 percent of patients treated with placebo.taltz also met all major secondary endpoints in the study p><0.001). in this trial the overall safety profile of taltz was consistent with previously reported results.>