Janssen’s IL-23 inhibitor Tremfya has been accepted for NHS use by the UK’s National Institute for Health and Care Excellence (NICE) for the treatment of active psoriatic arthritis (PsA).
Tremfya (guselkumab) is a fully human monoclonal antibody (mAb) designed to selectively bind to and inhibit the IL-23 receptor – an key driver of progression in inflammatory diseases such as PsA.
NICE’s final appraisal document (FAD) recommends Tremfya to treat moderate-to-severe PsA in adults who have responded inadequately to disease-modifying antirheumatic drug (DMARD) therapy or who cannot tolerate them.
The positive recommendation is supported by results from the Phase III DISCOVER-1 and DISCOVER-2 clinical trials, which evaluated the safety and efficacy of Tremfya in adults with active PsA.
Across both studies, Janssen’s drug demonstrated a favourable risk-benefit profile, showing statistically significant benefits compared to placebo on disease activity, joint and skin symptoms, functional capacity and health-related quality of life.
“[Tremfya] is not only a new treatment option for people with active psoriatic arthritis, but also the first IL-23 inhibitor to be approved as a treatment for PsA,” said Amanda Cunnington, patient access and health affairs director, Janssen-Cilag Limited.
“While we are pleased that NICE, in its recommendation, has identified the benefits this treatment can bring to people who are severely affected by PsA, we recognise there is still an unmet need for a wider population of people living with this chronic condition. We will continue to collaborate with NICE to broaden access for all patients with PsA who could potentially benefit from [Tremfya],” she added.
NICE has already recommended Tremfya for the treatment of eligible patients with moderate-to-severe plaque psoriasis.
The FAD for Tremfya treatment in PsA will be used to form the basis of the final technology appraisal guidance (TAG) issued to the NHS in England and Wales, with expected publication in June 2021.