Janssen Receives EC's Approval for the Expanded Use of Stelara (Ustekinumab) to Treat Pediatric Patients with Moderate to Severe Plaque Psoriasis
Shots:
- 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
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Ref: J&J | Image: Janssen
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