Publicado 11/10/2018 12:57:13CET
Lupus is a chronic, inflammatory autoimmune disease that can affect many different body systems, including joints, skin, heart, lungs, kidneys and brain. SLE can range from mild to severe and is characterised by inflammation of any organ system and complex auto-antibody production (antibodies directed against normal human tissue). The disease most often affects women and disproportionately affects women of African American, Hispanic, Asian and Native American descent compared to Caucasian women. Incidence rates vary across European countries, ranging from 2.2 cases/100,000 in Spain to 5 cases/100,000 in France. Lupus is estimated to affect at least 5 million people worldwide.
About psoriatic arthritis
Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis. It is estimated that one third of the 125 million people who are living with psoriasis worldwide will also develop psoriatic arthritis. The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time. Though the exact cause of psoriatic arthritis is unknown, genes, the immune system, and environmental factors are all believed to play a role in the onset of the disease.
The most common form of psoriasis is plaque psoriasis, usually resulting in areas of thick, red or inflamed skin covered with silvery scales which are known as plaques. The inconsistent nature of psoriasis means that even when plaques appear to subside, many patients still live in fear of their return.
Psoriasis can cause great physical and psychological burden. A study comparing psoriasis to other prominent conditions found its mental and physical impact comparable to that seen in cancer, heart disease and depression. Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis. In addition, many individuals are faced with social exclusion, discrimination, and stigma because of their disease.
In the European Union, ustekinumab is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA), and is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies. In addition, ustekinumab is approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. Ustekinumab is approved by the European Commission for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-alpha antagonist or have medical contraindications to such therapies.
*Ustekinumab is currently under investigation and is not approved for SLE. A Phase 3 programme evaluating ustekinumab in the treatment of adults with active SLE is ongoing.
The common (greater than or equal to1/100) adverse reactions reported in controlled periods of the adult psoriasis, psoriatic arthritis and Crohn's disease clinical studies with ustekinumab as well as post-marketing experience were: upper respiratory tract infection, arthralgia, back pain, diarrhoea, dizziness, fatigue, headache, injection site pain, injection site erythema, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus and vomiting.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to ustekinumab, which is currently approved for the treatment of moderate to severe plaque psoriasis in 90 countries, paediatric psoriasis in 43 countries, psoriatic arthritis in 83 countries and Crohn's disease in 62 countries.
STELARA(R) (ustekinumab) is a registered trademark of Johnson & Johnson.
Important Safety Information
For complete European Union (EU) prescribing information, please visit: www.medicines.org.uk/emc/product/4413/smpc [http://www.medicines.org.uk/emc/product/4413/smpc ].
Guselkumab is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23. Guselkumab received marketing authorisation from the European Commission in November 2017 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. In May 2018, the National Institute for Health and Care Excellence (NICE) issued its Final Appraisal Determination (FAD) recommending guselkumab for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
**Guselkumab is currently under investigation and is not approved for active psoriatic arthritis. A Phase 3 programme evaluating guselkumab in the treatment of adults with active psoriatic arthritis is ongoing.
The most common side effects of guselkumab include upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhoea, stomach flu (gastroenteritis), fungal skin infections, urticaria and herpes simplex infections.
TREMFYA(R) (guselkumab) is a registered trademark of Johnson & Johnson.
Important Safety Information
For complete European Union (EU) prescribing information, please visit: www.ema.europa.eu/documents/product-information/tremfya-epar-product-information_en.pdf [https://www.ema.europa.eu/documents/product-information/tremfya-epar-product-information_en.pdf ]
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/EMEA [http://www.janssen.com/emea ]. Follow us on Twitter at twitter.com/JanssenEMEA [https://twitter.com/JanssenEMEA ]. Janssen-Cilag International NV is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
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