BEERSE - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the expanded use of TREMFYA (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA) in the European Union (EU).
Guselkumab is currently approved in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1
Guselkumab is a monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver in the pathogenesis of inflammatory diseases such as PsA, psoriasis and others.2
'This positive opinion brings us closer to the addition of guselkumab to the drug armoury for the management of psoriatic arthritis, which is of critical importance for patients. Psoriatic arthritis is an impactful, multifaceted and currently incurable disease,' said Professor Iain McInnes,i Muirhead Professor of Medicine and Director of the Institute of Infection Immunity and Inflammation, University of Glasgow. 'Long-term control of the diverse symptoms in joints, skin and soft tissue is required. If approved, guselkumab would be a welcome addition to our therapeutic options in the management of this disease.'
PsA is a 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.3 There is no known cure, and it is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also go on to develop PsA.4,5
The CHMP positive opinion is based on data from DISCOVER-1 and DISCOVER-2, two first-in-class Phase 3 clinical studies, that demonstrated the efficacy and safety of guselkumab 100 mg q4w and q8w for the treatment of active PsA in adult patients. Data from these studies were recently published in The Lancet in March 2020.6,7
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.6 DISCOVER-2 included 739 patients who were biologic-naive only and had an inadequate response to standard therapies.7
Results published in The Lancet showed that in both studies, at week 24, the primary endpoints of American College of Rheumatology (ACR) 20 percent improvement (ACR20) achieved statistical significance (DISCOVER-1: p
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