The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Previously, the product had only been approved for adults.
Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. The approval was based on data from a multicenter, double-blind, placebo-controlled phase 3 study (IXORA-Peds) that evaluated the efficacy and safety of ixekizumab in 171 patients aged 6 to less than 18 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients were randomized to receive either Taltz or placebo with dosing stratified by weight.
The co-primary end points at week 12 were Psoriasis Area and Severity Index (PASI 75) response, defined as a patient that achieved a 75% reduction from baseline in the PASI score, as well as Static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with ≥2 point improvement from baseline. Key secondary end points included PASI 90, PASI 100, sPGA of 0, and an improvement of itch severity as measured by a reduction of ≥4 points on an 11-point itch Numeric Rating Scale (NRS).
Findings from the study showed that ixekizumab demonstrated superiority to placebo, with a significantly greater proportion of patients achieving the co-primary end points of PASI 75 (89% vs 25%) and sPGA of 0 or 1 (81% vs 11%) at week 12 (P <.001). Additionally, a significantly greater proportion of patients treated with ixekizumab met all secondary end points at week 12 compared with placebo, including PASI 90 (78% vs 5%), PASI 100 (50% vs 2%), sPGA of 0 (52% vs 2%), and ≥4 point improvement on itch NRS (71% vs 20%).
The safety profile of ixekizumab was consistent with that seen in previous studies with the exception of the frequencies of conjunctivitis (2.6%), influenza (1.7%), and urticaria (1.7%). In the pediatric trial, Crohn disease occurred at a greater frequency in the ixekizumab group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period; Crohn disease occurred in a total of 4 ixekizumab-treated patients (2.0%) in the clinical trial.
Taltz is also approved for the treatment of active psoriatic arthritis and active ankylosing spondylitis in adults.
The product is available as an 80mg/mL single-dose prefilled autoinjector and as an 80mg/mL single-dose prefilled syringe. Taltz doses of 20mg or 40mg must be prepared and administered by a healthcare professional; the 80mg/mL prefilled syringe should be used to prepare the prescribed 20mg and 40mg pediatric dose.
For more information visit taltz.com.