Janssen claimed that its Tremfya is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of PsA and plaque psoriasis
Magnetic resonance images of the fingers in psoriatic arthritis. (Credit: Fiona McQueen, Marissa Lassere and Mikkel Østergaard/Wikipedia.)
Johnson & Johnson’s pharmaceutical company Janssen has received the European Commission (EC) approval for Tremfya (guselkumab) to treat active psoriatic arthritis (PsA).
The EC approval indicated Tremfya for adults with PsA, with inadequate response or intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.
Tremfya is a fully human monoclonal antibody, designed to bind specifically to the p19 subunit of interleukin (IL)-23 and inhibit its interaction with the IL-23 receptor.
Janssen said that the drug has already been approved for the treatment of moderate to severe plaque psoriasis.
PsA is a chronic, multifaceted, progressive, immune-mediated inflammatory disease characterised by severe joint damage and inflammation, in addition to enthesitis, dactylitis, axial disease, and skin lesions related to psoriasis.
Also, more than half of people with PsA suffer from another condition, including cardiovascular disease, osteoporosis, inflammatory bowel disease or depression.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), granted on 15 October.
European Federation of Psoriasis Patient Organisations (EUROPSO) president Jan Koren said: “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.
“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.”
EC approval for Tremfya is based on DISCOVER-1 and DISCOVER-2 studies
The EC approval for the new indication is supported by results from the Phase 3 clinical studies DISCOVER-1 and DISCOVER-2, which evaluated safety and efficacy of Tremfya in treating active PsA in adults.
DISCOVER-1 assessed 381 participants with active PsA who had an inadequate response to standard therapies, including participants previously treated with anti-tumour necrosis factor (TNF) alpha biologics.
DISCOVER-2 assessed 739 patients who were biologic-naïve only and had an inadequate response to standard therapies.
In both the studies, treatment using Tremfya in patients with active PsA demonstrated 20% improvement at week 24, which is the primary endpoint, compared to placebo.
Also, the treatment was well tolerated and showed significant improvement in quality of life, with adverse events (AEs) consistent with previous studies of Tremfya.
Janssen R&D global immunology therapeutic area head David M Lee said: “Guselkumab represents a new treatment option – the first in its class – for patients with psoriatic arthritis, in an area where additional treatment options are needed.
“The DISCOVER 1 and 2 studies, which this approval is based on, show the potential of guselkumab to improve skin and joint symptoms, including structural joint damage, which are all important elements of sustained management of psoriatic arthritis.
“Today’s approval marks an exciting breakthrough as we continue to reimagine what is possible in how immune-mediated diseases like active PsA are understood and treated.”