Ustekinumab Approved For Pediatric Patients With Active Psoriatic Arthritis

Today, the US Food and Drug Administration announced approval of ustekinumab for the treatment of pediatric patients aged 6 years and older with active psoriatic arthritis (PsA).

Ustekinumab is a human monoclonal antibody that inhibits both IL-12 and IL-23, which has already been indicated for adult patients with moderate to severe plaque psoriasis (PsO). This approval makes ustekinumab the first and only biologic to treat pediatric patients aged 6 years and older with active PsA.

The approval was granted based on the efficacy and safety profile following pharmacokinetic (PK) data observed in multiple Phase 3 studies that consisted of adult and pediatric patients with moderate to severe plaque PsO. These data demonstrated that ustekinumab PK exposure in pediatric patients with PsO and active PsA was consistent with that of Phase 3 clinical trials of ustekinumab in pediatric patients with PsO without PsA. Additionally, common efficacy end points were similar in these pediatric patients with PsO and active PsA.

Ustekinumab comes with a boxed warning for serious infections, including tuberculosis and infections caused by bacteria, fungi, or viruses because it does affect the immune system. Additional adverse reactions include nasal congestion, sore throat, runny nose, fever, headache, tiredness, itching, nausea, vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

Reference
STELARA (ustekinumab) approved by the U.S. Food and Drug Administration to treat pediatric patients with active psoriatic arthritis. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. August 1, 2022. Accessed August 1, 2022. https://www.prnewswire.com/news-releases/stelara-ustekinumab-approved-by-the-us-food-and-drug-administration-to-treat-pediatric-patients-with-active-psoriatic-arthritis-301596940.html?tc=eml_cleartime