Officials with the FDA have granted approval to ixekizumab (Taltz, Eli Lilly) injection, 80 mg/mL for the treatment of pediatric patients with moderate-to-severe plaque psoriasis, according to a press release.
With this approval, ixekizumab is the first interleukin 17A (IL-17A) available for the treatment of this population, according to Eli Lilly.
Ixekizumab was first approved by the FDA in March 2016 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Ixekizumab received subsequent approvals for adults with active psoriatic arthritis and active ankylosing spondylitis.
This expanded pediatric indication was based on data from a phase 3 study that included 171 patients aged 6 to under 18 years old with moderate-to-severe plaque psoriasis.
Patients received either placebo or ixekizumab at varying doses dependent on weight: 20 mg for <25 kg, 40 mg for 25 to 50 kg, or 80 mg for >50 kg through week 12, with 40 mg, 80 mg, or 160 mg starting doses, respectively. The co-primary endpoints of the study were the proportion of patients achieving a 75% 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.
At 12 weeks:
- Eighty-nine percent of patients treated with ixekizumab achieved PASI 75 compared with 25% of patients treated placebo.
- Eighty-one percent of patients treated with ixekizumab achieved sPGA 0,1 compared with 11% of patients treated with placebo.
Additionally, ixekizumab met all major secondary endpoints of the study (P<0.001), which included the proportion of patients achieving PASI 90, sPGA (0) and PASI 100 at week 12, and at least a 4-point improvement in Itch Numeric Rating Scale (Itch NRS ≤4) among patients with baseline Itch NRS ≥4 at week 12, as well as PASI 75 and sPGA 0,1 at week 4.
The safety profile observed in pediatric patients with plaque psoriasis treated with ixekizumab every 4 weeks is consistent with the safety profile in adult patients, with the exception of conjunctivitis, influenza, and uriticaria. Over the 12-week study period, Crohn disease occurred at a greater frequency in the ixekizumab-treated group (0.9%) than the placebo group (0%).
Ixekizumab should not be used in patients with previous serious hypersensitivity to ixekizumab or any of the excipients.
“As I have often seen in my clinic, psoriasis is particularly challenging for children and adolescents, resulting in itchy and painful symptoms that can feel especially embarrassing for pediatric patients during a crucial developmental period in their young lives,” Jennifer Cather, MD, Modern Research Associates, Dallas, Texas, said in a statement. “In the phase 3 pediatric study, half of patients treated with ixekizumab achieved achieved completely clear skin after only 12 weeks of treatment. These results and the subsequent FDA approval make a strong case for Taltz as an effective treatment option for doctors to consider for pediatric patients with moderate to severe plaque psoriasis.”
1. Lilly’s Taltz (ixekizumab) Receives US FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis [news release]. Eli Lilly’s website. https://investor.lilly.com/news-releases/news-release-details/lillys-taltzr-ixekizumab-receives-us-fda-approval-treatment-1. Accessed April 6, 2020.