Stelara approved by the FDA to treat pediatric patients with active psoriatic arthritis

This rare disease that resembles adult PsA affects five to eight percent of children and adolescents with chronic inflammatory arthritis. Two of the four indications for Stelara now include pediatric patients, further expanding its treatment profile since the first approval in 2009 for adults living with moderate to severe plaque psoriasis (PsO).

Stelara is a fully human monoclonal antibody that selectively inhibits both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in tempering the overactive inflammatory response in several autoimmune diseases. Stelara is administered as a subcutaneous injection dosed four times per year after two starter doses for the treatment of pediatric patients six years of age and older with active PsA.

The FDA’s approval was based on pharmacokinetic (PK) data and extrapolation of the established efficacy and existing safety profile of Stelara in multiple Phase III studies in adult and pediatric patients with moderate to severe plaque PsO (PSTELLAR, CADMUS, and CADMUS Jr) and adult patients with active PsA (PSUMMIT I and II). With the limited availability of pediatric PsA patients for inclusion in clinical trials, researchers utilized an extrapolation approach based on previous PK, efficacy and safety observations from a closely adjacent population of pediatric 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.

An analysis of the data demonstrated that PK exposure of Stelara in these pediatric PsO patients with active PsA was consistent with that of Phase III clinical trials of Stelara in pediatric PsO patients without active PsA, as well as with adult patients with moderate to severe plaque PsO or adult patients with active PsA, while data on common efficacy endpoints were similar in these pediatric PsO patients with active PsA.

Access to Stelara :Janssen is actively working toward greater patient accessibility through improved commercial first-line formulary coverage, as well as patient-specific support services specifically for patients to start and stay on Stelara treatment after a prescribing decision has been made. StelarawithMe offers a comprehensive support program that helps patients get started on STELARA and stay on track. StelarawithMe provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and identifies options that may help make treatment more affordable, including the Stelara withMe Savings Program for commercially insured patients who are eligible.