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FDA Approves Stelara® for Pediatric Psoriasis Patients

On July 30, 2020, the U.S. Food and Drug Administration approved the use of Stelara® (ustekinumab) for use in pediatric patients, 6 to 11 years of age who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis.

Stelara®, manufactured by The Janssen Pharmaceutical Companies of Johnson & Johnson, is a biologic treatment that targets both cytokines interleukin 12 (IL 12) and IL 23, which are considered to play an important role in psoriasis.

In the Phase 3 CADMUS Junior study, the patients with moderate-to-severe plaque psoriasis, aged 6 years to younger than 12 years, received Stelara®. After 12 weeks, 77 percent of patients achieved Physician's Global Assessment (PGA) 0/1 response. Additionally, 84 percent of patients achieved Psoriasis Area and Severity Index (PASI) 75 and 64 percent achieved PASI 90 response.[i]

“There are three approved agents [for pediatric patients]; Enbrel/etanercept is the only approved TNF inhibitor and is given weekly and often used (in combination with methotrexate) by rheumatologists for the psoriatic arthritis component; ustekinumab/Stelara is anti-IL-12/IL-23 and is given every 3 months. Ixekizumab/Taltz, a monthly injection, was recently approved for 6 years and older and targets IL-17A.  Ustekinumab and ixekizumab are the most effective of the injectables for children - with about 80 percent achieving 90 percent reduction in psoriasis severity and more than 50 percent achieving clearance,” said Amy Paller, M.D., the chair of the dermatology department at Northwestern University. “Besides being among the most efficacious (with dramatic results sometimes within weeks after the loading dose), Stelara® is only given every 3 months -- which is desirable to families.”

The Janssen treatment was previously approved 1) for the treatment of adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn's disease; 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis.



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