The US FDA has approved an expanded indication for ustekinumab (Stelara) for the treatment of paediatric patients (6-11 years of age) with moderate to severe plaque psoriasis (PsO), announced Janssen Pharmaceuticals.
Plaque psoriasis is the most common form of psoriasis in adults and children. It is an inflammatory, immune-mediated disease resulting in overproduction of skin cells which causes raised, red, scaly plaques that may be itchy or painful.
Ustekinumab acts by targeting both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in modulating the overactive inflammatory response in a number of autoimmune conditions, including PsO. The drug is administered as a subcutaneous injection, dosed four times per year after two starter doses.
The approval for paediatric use is based on results from the CADMUS Junior study, an open-label, single-arm, multicentre phase 3 clinical trial, of 44 patients with moderate to severe plaque psoriasis in which 77 percent of patients achieved clear or almost clear skin, at week 12 after two doses. Secondary endpoints included the proportion of patients achieving 75 percent or 90 percent improvement in their Psoriasis Area and Severity Index (PASI) score at week 12 compared to baseline.
Study results showed 84 percent and 64 percent of patients achieved a PASI 75 response and PASI 90 response, respectively. In general, the safety profile observed in CADMUS Junior was similar to the safety profile from studies in adults with plaque psoriasis, said the company.