- The indication is the fifth for ustekinumab (STELARA)
- The approval was based on 12-week outcomes in skin clearance
- Ustekinumab is dosed 4 times annually after 2 starter doses
The expansion makes history for the injection biologic.
The US Food and Drug Administration (FDA) has approved an expanded indication for ustekinumab (STELARA) as a treatment for pediatric patients aged 6-11 years old who have skin lesions or plaques associated with moderate to severe plaque psoriasis.
The injection interleukin-12 and -23 (IL-12; IL-23) inhibitor becomes the first biologic approved to target such pathways in this patient age population. It was approved based on the results of the CADMUS Junior study, an open-label, single-arm, multicenter phase 3 clinical in which 44 patients with moderate to severe plaque psoriasis were assessed.
Investigators observed that 77% of treated patients achieved clear or almost clear skin at week 12, following their second dose of ustekinumab. In secondary endpoints, 84% and 64% of treated patients achieved Psoriasis Area and Severity Index (PASI) scores of 75 and 90, respectively, at week 12.
The observed ustekinumab safety profile was similar to that observed in adults with plaque psoriasis.
As an injection therapy dosed 4 times annually after 2 starter doses, ustekinumab has been previously approved by the FDA for the treatment of adults and pediatric patients with moderate to severe plaque psoriasis who are phototherapy of systemic therapy candidates; adultsvwith active psoriatic arthritis; adults with Crohn’s disease; and adults with moderalty to severe active ulcerative colitis.
As plaque psoriasis presents variably in patients, clinicians face a challenge in both diagnosing and treating the chronic condition, Stacie Bell, PhD, Chief Scientific and Medical Officer of the National Psoriasis Foundation, said.
“Especially in the pediatric population, it is important for patients, parents and physicians to work together to identify an appropriate treatment,” Bell said in a statement. “The approval of new treatment options is an exciting step forward to address the unmet needs of children living with psoriasis.”