FDA Approves Stelara in Children with Psoriatic Arthritis

Stelara is the first biologic targeting both cytokines IL-12 and IL-23 and offers a therapeutic option for children six years of age and older living with active psoriatic arthritis, a rare disease.

The FDA has approved Stelara (ustekinumab) to treat children six years of age and older with active psoriatic arthritis (PsA). 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 inflammatory response in several autoimmune diseases.

The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a supplemental biologics license application to the FDA in October 2021. The submission is based on data extrapolated from a total of nine studies in adult trials in active psoriatic arthritis and adult and pediatric studies in moderate-to-severe plaque psoriasis.

“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,” Terence Rooney, M.D., Ph.D., vice president, rheumatology and maternal fetal disease area, Janssen Research & Development, said in a press release.

With the limited availability of children with psoriatic arthritis for inclusion in clinical trials, researchers used an extrapolation approach based on previous pharmacokinetic, efficacy and safety observations from a population of pediatric patients with moderate-to-severe plaque psoriasis who also had active psoriatic arthritis, as well as adult patients with moderate-to-severe plaque psoriasis or psoriatic arthritis.

An analysis of the data demonstrated that pharmacokinetic exposure of Stelara in these pediatric patients was consistent with that of phase 3 clinical trials in pediatric patients with plaque psoriasis who did not have active psoriatic arthritis, as well as with adult patients. Data on common efficacy endpoints were similar in these pediatric patients.

Stelara is approved in the United States for the treatment of: adults and children 6 years and older with moderate-to-severe plaque psoriasis; adult patients with active psoriatic arthritis; adult patients with moderately to severely active Crohn’s disease or ulcerative colitis.

Juvenile psoriatic arthritis accounts for about 5% to 8% of all cases of juvenile arthritis cases. It is characterized by both joint inflammation and psoriatic skin lesions that resemble adult psoriatic arthritis.