The Janssen Pharmaceutical Company of Johnson and Johnson announced that European Commission approved the use of Stelara (Ustekinumab) in pediatric patients with plaque psoriasis. The drug has been earlier approved for adolescents and adults with plaque psoriasis.
“This latest EC approval is a significant milestone for young children struggling to cope with the symptoms of psoriasis,” said Lloyd Miller, Vice President, Immunodermatology Disease Area Leader, Janssen Research & Development, LLC.
The approval of the drug was based on Phase 3 CADMUS Jr study building on prior Phase 3 CADMUS study. The primary endpoint was percentage of patients who achieved physician’s global assessment (PGA) score of Cleared (0) or Minimal (1) at week 12. Psoriasis area and severity index of ≥75% (PASI 75), ≥90% (PASI 90), and change from baseline in Children’s Dermatology Life Quality Index (CDLQI) at week 12 were considered as secondary endpoints.
Study results at week 12 were:
· 77.3% achieved PGA 0/1
· 84.1% achieved PASI 75
· 63.6% achieved PASI 90
Psoriasis is an autoimmune disorder that manifests in the skin. Plaque psoriasis is most common psoriasis, manifested by inflamed and red skin. The diseases have severe impact on quality of life of patients.
Stelara is indicated for psoriasis, pediatric plaque psoriasis, psoriatic arthritis, Crohn's disease (CD) and ulcerative colitis (UC). Janssen holds exclusive worldwide rights on Stelara.