The US Food and Drug Administration, according to a notice from 1 its manufacturer, Janssen.
The approval makes jPsA the sixth approved indication for ustekinumab, which includes active psoriatic arthritis in adults, moderate-to-severe plaque psoriasis in adults and children 6 years and older who are candidates for phototherapy or systemic therapy, moderate-to-severe active Crohn’s disease Adults and moderately to severely active ulcerative colitis in adults.
In addition, ustekinumab is now the second biologic to be approved for jPsA, following agency approval of secukinumab (Cosentyx) in December 2021 for the treatment of jPsA in children and adolescents 2 years of age and older and enthesitis-related arthritis in children and adolescents Age 4 years and older.
In pediatric patients, ustekinumab is administered as a subcutaneous injection four times a year after two loading doses.
According to Janssen, the approval of ustekinumab is based on “an extrapolation of the established data and the existing safety profile” of ustekinumab in multiple phase 3 studies in adult and pediatric patients with moderate to severe plaque psoriasis and adult patients with active PsA.
“Given the limited availability of pediatric patients for enrollment in clinical trials, researchers can extrapolate data from adult studies to determine the potential efficacy and tolerability of a treatment for a pediatric population,” the company’s October 2021 announcement read. that the Biologics License Application has been filed with the FDA.
Juvenile arthritis occurs in an estimated 20 to 45 children in every 100,000 in the United States, with about 5% of these children having jPsA, according to the National Psoriasis Foundation.
The prescribing information for ustekinumab includes specific warnings and concern areas. The drug should not be administered to people with known hypersensitivity to ustekinumab. The drug can reduce the immune system’s ability to fight infection and increase the risk of infections, sometimes serious, and a test for tuberculosis infection should be done before administration.
Patients taking ustekinumab should not receive a live vaccine, and their doctors should be informed if anyone in their household needs a live vaccine. Also, according to Johnson & Johnson, they should not receive the BCG vaccine during the 1 year prior to receiving the drug or 1 year after stopping its use.
The most common side effects are nasal congestion, sore throat, runny nose, upper respiratory tract infection, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infections, bronchitis, diarrhea, abdominal pain and joint pain.
For more updates, follow Medscape on Facebook, TwitterInstagram and YouTube.