The safety results of STELARA observed in the PSUMMIT studies were consistent with the known safety profile of STELARA in the labelled moderate to severe plaque psoriasis indication with up to 5 years of safety experience in clinical trials. For more information regarding the safety profile for STELARA, please see "Important Safety Information" below.
About Psoriatic Arthritis
Psoriatic arthritis [http://psoriasis.org/psoriatic-arthritis ] is a chronic immune-mediated inflammatory disease characterised by both joint and surrounding tissue inflammation, and the skin lesions associated with psoriasis, which affects as many as 37 million people worldwide and approximately 4.2 million people across Europe.- While estimates of the prevalence of psoriatic arthritis among people living with psoriasis vary, up to 30 percent may develop inflammatory arthritis. Although the exact cause of psoriatic arthritis is unknown, it is believed to be an immune-mediated inflammatory disease with a genetic link. Environmental factors may play a role in the development of the disease. Early signs of psoriatic arthritis can include enthesitis and dactylitis. Other arthritic symptoms of psoriatic arthritis include swelling, pain, stiffness of the joints and surrounding tissue, and reduced range of motion.,
About STELARA(R) (ustekinumab)
STELARA, a human interleukin (IL)-12 and IL-23 antagonist, is currently approved in 74 countries for the treatment of moderate to severe plaque psoriasis. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in immune-mediated inflammatory diseases, including psoriasis and psoriatic arthritis.
STELARA is not recommended for use in children and adolescents below age 18 as studies in the paediatric population have not yet been completed.
Important Safety Information
Ustekinumab is a selective immunosuppressant and may have the potential to increase the risk of infections and reactivate latent infections. Serious infections have been observed in patients receiving STELARA in clinical trials. Do not start STELARA during an active infection. If a serious infection develops, monitor patients carefully and stop STELARA until the infection resolves. Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment with STELARA.
Ustekinumab is a selective immunosuppressant. Immunosuppressive agents have the potential to increase the risk of malignancy. Malignancies have been observed in patients receiving ustekinumab in clinical trials. Caution should be exercised when considering the use of STELARA in patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
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