The Food and Drug Adminstration gave the green light for Janssen Pharmaceutical Companies of Johnson & Johnson’s Stelara (ustekinumab) for the treatment of pediatric patients 6 years old and older with active psoriatic arthritis.
This rare disease that resembles adult PsA affects 5% to 8% of children and adolescents with chronic inflammatory arthritis.
Two of the four indications for Stelara now include pediatric patients, further expanding its treatment profile since the first approval in 2009 for adults living with moderate to severe plaque psoriasis.
Stelara is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in tempering the overactive inflammatory response in several autoimmune diseases. Stelara is administered as a subcutaneous injection dosed four times per year after two starter doses for the treatment of pediatric patients six years of age and older with active PsA.
“We know active pediatric psoriatic arthritis is a challenging inflammatory disease given its rarity and that symptoms, such as swollen joints and skin lesions, can vary significantly in presentation and severity,” said Terence Rooney, vice president of rheumatology and maternal fetal disease area at Janssen Research & Development.
“With this pediatric approval of Stelara, we’re pleased to help address the unmet needs of these young patients and provide physicians with a much-needed treatment option that has an established track record of safety and efficacy,” he said.
“The approval of Stelara for use in children six years of age and older with active psoriatic arthritis, which follows the 2020 approval for moderate to severe plaque psoriasis in this population, is complemented by more than 12 years of clinical trial and real-world evidence across all approved indications demonstrating the safety and efficacy of this biologic therapy” said said Jennifer Davidson, vice president of immunology medical affairs at Janssen Scientific Affairs. “As a global leader in immunology, Janssen is dedicated to reducing the burden of chronic autoimmune diseases, and this additional approval for Stelara builds on our legacy of bringing important treatment options to younger patients.”