- The EC’s approval is based on P-III CADMUS Jr study assessing Stelara (SC) in 44 pediatric patients with mod. to sev. PsO aged 6–11 yrs. from 9 countries. The study follows its prior P-III CADMUS study
- The P-III CADMUS Jr study results: @12wks. improvement in psoriasis and HrQOL; patients achieved PGA 0/1 (77.3%); PASI 75 (84.1%); PASI 90 (63.6%); change in CDLQI (-6.3). Following first administration of Stelara, patients were followed up to 52wks., improvement in PGA 0/1 (75.6%); PASI 75 (87.7%); PASI 90 (70.7%); CDLQI (58.3%) maintained @52wks.
- Stelara is the first biologic targeting IL-12 and IL-23 cytokines and has received CHMP’s positive opinion on Dec 12, 2019. The approval for expanded use of Stelara addresses the unmet medical need of pediatric patients
Click here to read full press release/ article | Ref: JNJ | Image: Business wire