According to a statement from Johnson & Johnson’s Janssen Pharmaceutical Companies, the FDA has approved Stelara (ustekinumab) for the treatment of children patients with active psoriatic arthritis who are six years of age or older (PsA)
Five to 8% of children and adolescents with chronic inflammatory arthritis have this unusual condition, which resembles adult PsA. Since its initial approval in 2009 for adults with moderate to severe plaque psoriasis, Stelara’s therapeutic profile has grown to cover two of the four indications for paediatric patients (PsO).
Interleukin (IL)-12 and IL-23, two cytokines that are expected to play a significant part in taming the hyperactive inflammatory response in a number of autoimmune disorders, are both selectively inhibited by the completely human monoclonal antibody called Stelara. For the treatment of paediatric patients six years of age and older with active PsA, Stelara is injected subcutaneously four times a year after two beginning doses.
Pharmacokinetic (PK) data and extrapolation of the demonstrated efficacy and current safety profile of Stelara in numerous Phase III studies in adult and paediatric patients with moderate to severe plaque PsO (PSTELLAR, CADMUS, and CADMUS Jr.), as well as adult patients with active PsA, served as the foundation for the FDA’s approval (PSUMMIT I and II).
The researchers used an extrapolation approach based on prior PK, efficacy, and safety observations from a closely adjacent population of paediatric patients with moderate to severe plaque PsO who also had active PsA, as well as adult patients with moderate to severe plaque PsO or active PsA, due to the limited availability of paediatric PsA patients for inclusion in clinical trials.
Data on common efficacy endpoints were similar in these paediatric PsO patients with active PsA, and an analysis of the data revealed that the PK exposure of Stelara in these paediatric PsO patients with active PsA was consistent with that of Stelara’s Phase III clinical trials in paediatric PsO patients without active PsA, as well as with adult patients with moderate to severe plaque PsO or adult patients with active PsA.
Access to Stelara: Janssen is actively working to improve commercial first-line formulary coverage and patient-specific support services to make Stelara more widely available to patients. These services are designed to help patients begin and continue Stelara treatment after a prescribing decision has been made.
A thorough support programme is provided by StelarawithMe to assist patients in starting and maintaining their STELARA regimen. StelarawithMe identifies solutions that can help make treatment more inexpensive, including the Stelara withMe Savings Program for qualified commercially insured patients, and provides information on insurance coverage, potential out-of-pocket costs, and treatment assistance.