Janssen's Stelara (ustekinumab) Receives the US FDA's Approval for the Treatment of Active Psoriatic Arthritis in Pediatric Patients
- The approval was based on the PK data from the P-III (PSTELLAR/CADMUS/CADMUS Jr) trial in adult & pediatric patients with plaque PsO & (PSUMMIT I & II) trial in adult patients with active PsA for Stelara
- The results showed that ustekinumab's PK exposure in pediatric PsO patients with active PsA was consistent with P-III trials in pediatric PsO patients without active PsA along with adult patients with PsO or with active PsA. The pediatric PsO patients with active PsA had similar data on similar effectiveness EPs
- The company launched STELARA withMe support program that offers access to patients to use Stelara & provides information on insurance coverage, out-of-pocket costs, treatment support & identifies options for affordable treatment to patients
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