Efficacy and Safety of Ixekizumab in a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Paediatric Patients with Moderate-to-Severe Plaque Psoriasis (IXORA-PEDS).

BACKGROUND: Plaque psoriasis affects children and adults, but treatment options for paediatric psoriasis are limited. OBJECTIVES: Evaluate the efficacy and safety of ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, for moderate-to-severe paediatric psoriasis. METHODS: In a randomised, double-blind, placebo-controlled, Phase 3 study (IXORA-PEDS), patients (age 6 to /=75% improvement in the Psoriasis Area and Severity Index (PASI 75) and a static Physician's Global Assessment score of 0 or 1 (sPGA 0,1). RESULTS: IXE was superior (p<0.001) to placebo for both co-primary endpoints (PASI 75: IXE Q4W, 89%; placebo, 25% and sPGA [0,1]: IXE Q4W, 81%; placebo, 11%) and all gated secondary endpoints, including PASI 75 and sPGA (0,1) at Week 4, improvement in itch, and complete skin clearance. IXE Q4W provided significant (p<0.001) improvements versus placebo in quality of life and clearance of scalp and genital psoriasis. Responses at Week 12 were sustained or further improved through Week 48. Through Week 12, 45% (placebo) and 56% (IXE) of patients reported treatment-emergent adverse events. One serious adverse event was reported (IXE), one patient discontinued due to an adverse event (placebo), and no deaths were reported. CONCLUSIONS: IXE was superior to placebo in the treatment of moderate-to-severe paediatric psoriasis and the safety profile was generally consistent with that observed in adults.