FDA approves Taltz for pediatric psoriasis
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The FDA has approved a supplemental biologics license application for ixekizumab in pediatric patients with moderate to severe plaque psoriasis, according to a press release from Eli Lilly.
The 80 mg/mL injection is approved for use in patients eligible for systemic therapy or phototherapy who are aged between 6 and 18 years.
“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, of Modern Research Associates, Dallas, said in the release. “In the phase 3 pediatric study, half of patients treated with Taltz 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.”Approval was based on data from a phase 3 randomized, double-blind, placebo-controlled study of 171 patients with moderate to severe disease. Co-primary endpoints were proportion of patients who achieved a 75% improvement from baseline on their Psoriasis Area and Severity Index score (PASI 75) and static Physician’s Global Assessment (sPGA) of clear or almost clear (0 or 1) skin at 12 weeks.
Patients were randomly assigned to placebo or Taltz (ixekizumab) 20 mg for patients weighing less than 25 kg, 40 mg for patients weighing 25 kg to 50 kg or 80 mg for patients weighing more than 50 kg for 12 weeks, with starting doses of 40 mg, 80 mg or 160 mg. At study end, statistically significantly more patients assigned to ixekizumab achieved the co-primary endpoints compared with placebo: 89% achieved PASI 75 vs. 25% (P < .001) and 81% achieved sPGA 0 or 1 vs. 11% (P < .001).
Secondary endpoints included the proportion of patients who achieved PASI 90, sPGA 0 and PASI 100 at week 12, and a four-point or greater improvement on the Itch Numeric Rating Scale at week 12 among patients with a baseline score of 4 or greater , PASI 75 and sPGA 0 or 1 at week 4, according to the release.
Conjunctivitis, influenza and urticaria were more frequent in patients assigned to ixekizumab. However, outside of these, the safety profile in pediatric patients was similar to the safety profile in adult patients with plaque psoriasis. Crohn’s disease was also more frequent among patients assigned to ixekizumab vs. placebo (0.9% vs. 0%).
“Due to limited pediatric psoriasis treatment options available, treating children and adolescents with moderate to severe plaque psoriasis can be challenging,” Stacie Bell, chief scientific and medical officer, National Psoriasis Foundation, said in the release. “Having more FDA-approved pediatric psoriasis treatment options available is a positive step forward in helping relieve the burden of psoriasis for pediatric patients, their families and the health care providers that treat these young patients.”