The European Commission has approved Janssen’s Tremfya (guselkumab) as a first-in-class treatment for active psoriatic arthritis (PsA).
The decision allows doctors to prescribe the drug for adults 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.
Tremfya is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 (a driver of inflammatory diseases) and inhibits its interaction with the IL23 receptor.
It is already on the market for patients with moderate to severe plaque psoriasis.
PsA is a chronic, progressive, immune-mediated inflammatory disease characterised by debilitating joint damage and inflammation, in addition to enthesitis, dactylitis, axial disease and the skin lesions associated with psoriasis.
More than half of people with PsA also live with another condition, such as cardiovascular disease,
osteoporosis, inflammatory bowel disease or depression.
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, Janssen notes.
“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 was based on results from the DISCOVER-1 and DISCOVER-2 Phase III clinical studies, which showed that adults with active PsA achieved statistical significance in the primary endpoint of American College of Rheumatology (ACR) 20% improvement (ACR20).
Crucially significant improvements were also shown on quality of life scores and structural damage progression.