medwireNews: The US FDA has expanded the indication for ustekinumab, an interleukin (IL)-12/23 inhibitor, to include pediatric patients with psoriatic arthritis (PsA).
Previously approved for the treatment of PsA, psoriasis, and inflammatory bowel disease in adults, ustekinumab may now be given to children aged 6 years and older with active PsA.
The IL-12/23 inhibitor is administered subcutaneously once every 12 weeks in children and adolescents aged 6–17 years, following loading doses at weeks 0 and 4, with dosing based on bodyweight.
The FDA says that approval of ustekinumab in the pediatric PsA population is based on efficacy and pharmacokinetic studies in adults with PsA and psoriasis, and safety data from studies involving children with psoriasis.
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