The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J)’s Stelara (ustekinumab) to treat paediatric patients aged six years and above with active psoriatic arthritis (PsA).
The latest approval was based on pharmacokinetic (PK) findings and extrapolation of the validated efficacy and current safety profile of Stelara in various Phase III clinical trials carried out in adult and paediatric moderate-to-severe plaque psoriasis (PsO) patients and adult active PsA patients.
The Phase III PSTELLAR, CADMUS and CADMUS Jr trials enrolled PsO patients while PSUMMIT I and II studies enrolled PsA patients.
Findings showed that PK exposure of Stelara in paediatric PsO patients with active PsA was in line with that of Phase III trials of the therapy in patients without active PsA.
Furthermore, the exposure was consistent with adults having moderate to severe plaque PsO or adult active PsA patients.
A completely human monoclonal antibody, Stelara hinders cytokines interleukin (IL)-12 and IL-23.
It is claimed to be the first and only biologic that acts on the cytokines, offering a new treatment option for children aged six years and above with active PsA.
Stelara is given as subcutaneous injection four times a year following a starter regimen of two doses to treat paediatric active PsA patients of this age group.
Currently, the antibody is approved in the US to treat people aged six years and above with moderate to severe PsO, active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and ulcerative colitis.
Janssen Research and Development Rheumatology and Maternal Fetal Disease Area vice-president Terence Rooney said: “We know active paediatric psoriatic arthritis is a challenging inflammatory disease given its rarity and that symptoms such as swollen joints and skin lesions can vary significantly in presentation and severity.
“With this paediatric approval of Stelara, we’re pleased to help address the unmet needs of these young patients and provide physicians with a much-needed treatment option that has an established track record of safety and efficacy.”