NICE Approves Janssen's Tremfya for Active Psoriatic Arthritis in NHS Reimbursement

Compiled & Translated by | Fan Dongdong

Recently, Johnson & Johnson's Janssen IL-23 inhibitor Tremfya has been recommended by the UK National Institute for Health and Care Excellence (NICE) for use within the UK National Health Service (NHS) 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. This receptor is a key driver in the progression of inflammatory diseases such as PsA. The Final Appraisal Document (FAD) from NICE recommends Tremfya for the treatment of adult patients with moderate to severe PsA who have had an inadequate response to or are intolerant of disease-modifying antirheumatic drugs (DMARDs).

This positive recommendation is supported by the results of the Phase III DISCOVER-1 and DISCOVER-2 clinical trials, which evaluated the safety and efficacy of Tremfya in adults with active psoriatic arthritis (PsA). In both studies, the Johnson & Johnson IL-23 inhibitor demonstrated a favorable risk-benefit profile. Compared with placebo, Tremfya showed statistically significant benefits in disease activity, joint and skin symptoms, physical function, and health-related quality of life.

DISCOVER-1 enrolled 381 patients with active psoriatic arthritis (PsA) who had an inadequate response to standard therapy, including those who had previously received anti-tumor necrosis factor-alpha (anti-TNFα) biologic therapy (approximately 30%). DISCOVER-2 enrolled 739 biologic-naïve patients with an inadequate response to standard therapy. Results from both studies showed that at Week 24, compared with the placebo group, the American College of Rheumatology 20% improvement (ACR20) response in adult patients with active PsA in the every-4-week and every-8-week treatment groups achieved statistical significance, meeting the primary endpoint of the trials.

Additionally, in DISCOVER-1, patients in the Tremfya group demonstrated significant improvement in quality of life scores compared with the placebo group; in DISCOVER-2, patients receiving Tremfya every 4 weeks also demonstrated significant improvement in quality of life scores compared with the placebo group. At Week 24, radiographic progression of structural damage was significantly less in patients receiving Tremfya every 4 weeks compared with the placebo group, while the progression of structural damage was numerically lower in patients receiving Tremfya every 8 weeks compared with the placebo group. At Week 52, the mean change from baseline in the total modified vdH-S score in the Tremfya group remained similar to baseline.

In both studies, Tremfya was well tolerated, and the observed adverse events (AEs) were consistent with previous studies and the current prescribing information. In DISCOVER-2, less than 1% of patients experienced serious infections following treatment with Tremfya, while in DISCOVER-1, no patients experienced serious infections after Tremfya treatment. There were no reports of death among patients treated with Tremfya, and no patients treated with Tremfya developed inflammatory bowel disease, opportunistic infections (such as tinea or candidiasis), active tuberculosis, or hypersensitivity or serum sickness-like reactions.

The drug was first approved in the United States in July 2017 for the treatment of adults with moderate-to-severe plaque psoriasis (PsO), and was approved in July 2020 for the treatment of adults with active psoriatic arthritis (PsA). Previously, NICE had recommended Tremfya for eligible patients with moderate-to-severe plaque psoriasis. The Final Appraisal Document (FAD) for Tremfya in the treatment of PsA will serve as the basis for the final Technology Appraisal Guidance (TAG) to be issued to the NHS in England and Wales, which is expected to be published in June 2021.

Source: NICE green lights Tremfya to treat active psoriatic arthritis