J&J(US:JNJ) Prnewswire·2025-09-29 12:00Core Insights - Johnson & Johnson's TREMFYA (guselkumab) has received FDA approval for treating pediatric patients aged six years and older with moderate to severe plaque psoriasis and active psoriatic arthritis, marking it as the first IL-23 inhibitor approved for these indications [1][2][3] Group 1: Approval Details - TREMFYA's approval is based on the PROTOSTAR study, which demonstrated significant skin clearance in pediatric patients at Week 16, with 56% achieving PASI 90 compared to 16% on placebo [4][5] - The treatment is administered via subcutaneous injection at Week 0, Week 4, and then every 8 weeks, with a recommended dosage of 100 mg for pediatric patients [6][8] Group 2: Patient Impact - Approximately 20,000 children under 10 are diagnosed with plaque psoriasis annually, and around 14,000 are affected by psoriatic arthritis, highlighting the need for effective treatment options [2][3] - The approval addresses a significant gap in therapies for pediatric patients suffering from these chronic conditions, which can have long-term physical and emotional impacts [3][7] Group 3: Clinical Study Findings - In the PROTOSTAR study, co-primary endpoints were achieved, with 66% of patients on TREMFYA reaching high levels of skin clearance (IGA score of 0/1) at Week 16 compared to 16% on placebo [4][10] - Safety data indicated that 42% of patients receiving guselkumab reported adverse events, with common issues including nasopharyngitis and upper respiratory infections [10] Group 4: Broader Context - TREMFYA is part of Johnson & Johnson's ongoing commitment to innovate in the treatment of chronic immune-mediated diseases, with previous approvals for adult indications in ulcerative colitis and Crohn's disease [8][24] - The drug's mechanism involves blocking IL-23 and binding to CD64, which is significant in the treatment of immune-mediated diseases [7][15]