Belgium - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has approved TREMFYA (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
Guselkumab is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor. It is already approved for the treatment of patients with moderate to severe plaque psoriasis. IL-23 is an important driver of the progression of inflammatory diseases including psoriasis and PsA, among others.1
PsA is a multifaceted, chronic, immune-mediated inflammatory disease that is progressive and is characterised by debilitating joint damage and inflammation, in addition to enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. The pain, stiffness and swelling of the joints and connective tissue can be severe and cause everyday tasks to become difficult.2,3 In addition, more than half of people with PsA also live with another condition, such as cardiovascular disease, osteoporosis, inflammatory bowel disease or depression.4,5 There is currently no known cure for PsA, and it is estimated that up to a third of the 14 million people living with psoriasis in Europe will go on to develop PsA.6,7
'Psoriatic arthritis is a progressive and debilitating disease and can have a huge impact not only on quality of life, but also on a person's mental health. We welcome the news that guselkumab is now approved for the treatment of psoriatic arthritis,' said Jan Koren, President, European Federation of Psoriasis Patient Organisations (EUROPSO). 'For patients, having more innovative treatment options available that improve the quality of life is good news, which we believe will bring hope to many patients in need of additional treatment options. We must now work to make this treatment accessible to patients across the European Union.'
Approval for this new indication is based on results from the DISCOVER-1 and DISCOVER-2 Phase 3 clinical studies, which assessed safety and efficacy of guselkumab 100 mg q4w and q8w in adult patients with active PsA. DISCOVER-1 evaluated 381 participants with active PsA who had an inadequate response to standard therapies, including participants (30 percent) previously treated with anti-tumour necrosis factor (TNF) alpha biologics.8 DISCOVER-2 included 739 patients who were biologic-naive only and had an inadequate response to standard therapies.9 Data from these studies was published earlier this year in The Lancet (24-weeks; DISCOVER-1, DISCOVER 2).8,9
The published results show that in both studies, at week 24, adult patients with active PsA achieved statistical significance in the primary endpoint of American College of Rheumatology (ACR) 20 percent improvement (ACR20) response (DISCOVER-1: p
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