The Second Biologic for PsA in Children is Approved: Ustekinumab

By, SNEHA MAVIS

Ustekinumab (Stelara), a dual interleukin (IL)-12 and IL-23 inhibitor, has been authorized by the US Food and Drug Administration to treat juvenile psoriatic arthritis (jPsA) in patients over the age of 6 and older, the drug's producer Janssen announced on August 1. 

Ustekinumab now has six authorized indications, including active psoriatic arthritis in adults, moderate to severe plaque psoriasis in adults and children who are 6 years or older who are eligible for phototherapy or systemic therapy, moderate to severely active Crohn's disease in adults, and moderately to severely active ulcerative colitis in adults. 

Ustekinumab is given to pediatric patients as a subcutaneous injection four times per year following two starter doses.

According to the company's release from October 2021, "With the limited availability of pediatric patients for clinical study enrollment, researchers can extrapolate data from studies with adults to evaluate the potential tolerability and effectiveness of a drug for a pediatric population."

Ustekinumab's prescribing information offers specific cautions and areas of concern. People who are known to be allergic to ustekinumab should not take the medication. A test for tuberculosis infection should be done before administrating the medication. The drug may impair the immune system's capacity to battle infections and raise the risk of serious infections. Live vaccines shouldn't be administered to patients on ustekinumab. According to Johnson & Johnson, they should also avoid having the BCG vaccine for one year before starting the medicine and for one year after stopping it.

Stuffy nose, sore throat, rhinorrhea, upper respiratory infections, fever, headache, weariness, itching, nausea and vomiting, injection site redness, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, and stomach aches are the most common side effects.