HORSHAM - The Janssen Pharmaceutical Companies of
Plaque psoriasis is the most common form of psoriasis in adults and children.1 STELARA targets both interleukin (IL)-12 and IL-23, two cytokines thought to play an important role in modulating the overactive inflammatory response in a number of autoimmune conditions, including PsO. STELARA is administered as an injection given under the skin, dosed four times per year after two starter doses.
'We are thrilled that the latest approval for STELARA will bring an alternative class of medication to this patient population and that we are able to deliver on our promise to find meaningful solutions for people afflicted with immune-mediated diseases,' said
The FDA approval of STELARA for pediatric use is based on results from the CADMUS Junior study, an open-label, single-arm, multicenter phase 3 clinical trial, of 44 patients with moderate to severe plaque psoriasis in which 77 percent of patients achieved clear or almost clear skin, at week 12 after two doses. Secondary endpoints included the proportion of patients achieving 75 percent or 90 percent improvement in their Psoriasis Area and Severity Index (PASI) score at week 12 compared to baseline. Study results showed 84 percent and 64 percent of patients achieved a PASI 75 response and PASI 90 response, respectively. In general, the safety profile observed in CADMUS Junior was similar to the safety profile from studies in adults with plaque psoriasis.1 Patients knew they were on STELARA for the entirety of the study, which may affect results.
'Plaque psoriasis presents differently in all patients, making it a challenging disease to both diagnose and treat. Especially in the pediatric population, it is important for patients, parents and physicians to work together to identify an appropriate treatment,' said
Access for STELARA
Janssen will work closely with payers, providers and pharmacy benefit managers in an effort to help ensure STELARA is broadly accessible and affordable for patients living with PsO.
Janssen CarePath offers a comprehensive support program that helps patients get started on STELARA and stay on track. Janssen CarePath 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 Janssen CarePath Savings Program for commercially insured patients who are eligible.
About Psoriasis
Plaque psoriasis (PsO) is the most common form of psoriasis in adults and children. It is an inflammatory, immune-mediated disease resulting in overproduction of skin cells which causes raised, red, scaly plaques that may be itchy or painful.2 It is estimated that more than 8 million Americans and about 125 million people worldwide live with the disease. Nearly one-quarter of all people with PsO have cases that are considered moderate to severe.3 About one-third of people with psoriasis first have symptoms before the age of 20 years and approximately 20,000 children under the age of 10 are diagnosed with psoriasis.2
About STELARA (ustekinumab)
STELARA (ustekinumab), is the first and only biologic treatment in this patient population to target the interleukin (IL) 12/IL-23 pathways, an important therapeutic target for the condition.4 With this approval, STELARA is now the only IL-12/IL-23 inhibitor approved in
About the Janssen Pharmaceutical Companies of
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Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding STELARA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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