Janssen’s Stelara Wins Approval for Kids with Rare Arthritis

The U.S. Food and Drug Administration granted The Janssen Pharmaceutical Companies of Johnson & Johnson approval to market its drug Stelara for the treatment of pediatric patients six years of age and older with active psoriatic arthritis.

Psoriatic arthritis (PsA) is rare disease that resembles adult PsA and affects five to eight percent 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 for 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.”

The FDA’s approval was based on pharmacokinetic (PK) data and extrapolation of the established efficacy and existing safety profile of Stelara in multiple phase 3 studies in adult and pediatric patients with moderate to severe plaque psoriasis and adult patients with active PsA. With the limited availability of pediatric PsA patients for inclusion in clinical trials, researchers utilized an extrapolation approach based on previous PK, efficacy, and safety observations from a closely adjacent population of pediatric patients with moderate to severe plaque PsO who also had active PsA, as well as adult patients with moderate to severe plaque PsO or active PsA.

Author: Rare Daily Staff