FDA Approves Ustekinumab for Psoriatic Arthritis in Children

In pediatric patients, ustekinumab is administered as a dosed subcutaneous injection four times a year after two initial doses.

The approval becomes the sixth approved indication for ustekinumab. Photo: Shutterstock.

This Tuesday the US Food and Drug Administration approved the dual inhibitor of interleukin (IL)-12 and IL-23 ustekinumabknown on the market as Stelara, for the treatment of juvenile psoriatic arthritis (jPsA) in patients 6 years of age or older, the pharmaceutical company Janssen announced.

The approval becomes the sixth indication approved for ustekinumabincluding active psoriatic arthritis in adults, moderate to severe plaque psoriasis in both adults and children 6 years of age and older who are candidates for phototherapy or systemic therapy, moderate to severe active Crohn’s disease in adults, and ulcerative colitis moderately to severely active in adults.

Also, ustekinumab is now the second biologic approved for this population, following the agency’s December 2021 approval of secukinumab (Cosentyx) to treat this condition in children and adolescents 2 years of age and older, as well as enthesitis-related arthritis in children and adolescents 4 years and older.

The approval of ustekinumab is based on “an extrapolation of 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 psoriatic arthritis, according to Janssen.

“With the limited availability of pediatric patients for inclusion in clinical trials, researchers can extrapolate data from adult trials to determine the potential efficacy and tolerability of a treatment for a pediatric population,” according to the company’s October 2021 announcement. that the Biological License Application had been submitted to the FDA.

Juvenile arthritis occurs in an estimated 20 to 45 children per 100,000 in the United States, and about 5% of those children have this disease, according to the National Psoriasis Foundation.

The prescription information for ustekinumab includes specific warnings and areas of concern. The drug should not be administered to people with known hypersensitivity to ustekinumab. The drug may decrease the ability of the immune system to fight infection and may increase the risk of infections, sometimes serious, and a tuberculosis test should be performed before administration.

The patients who take ustekinumab they should not receive a live vaccine, and their doctors should be told if anyone in their household needs a live vaccine. They also should not receive the BCG vaccine for 1 year before receiving the drug or 1 year after stopping it, according to Johnson & Johnson.

The most common side effects include nasal congestion, sore throat, runny nose, upper respiratory tract infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal candidiasis, infections of the urinary tract, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain.

Source consulted here.

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