NICE approves Johnson & Johnson Tremfya to treat active psoriatic arthritis

A few days ago, Johnson & Johnson Xian Janssen IL-23 inhibitor Tremfya has been included in the NHS of the British healthcare system by the National Institute of 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 IL-23 receptors.

This positive recommendation is supported by the results of Phase III DISCOVER-1 and DISCOVER-2 clinical trials, which evaluated the safety and effectiveness of Tremfya in adults with active PsA.

DISCOVER-1 enrolled 381 patients with active PsA who did not respond adequately to standard therapies, including patients (about 30%) who had previously received anti-tumor necrosis factor (TNF) alpha biologics.
DISCOVER-2 enrolled 739 patients who had not received biologics treatment and had insufficient response to standard therapies.
The results of the two studies showed that at week 24, compared with the placebo group, the American College of Rheumatology (ACR) 20% improvement (ACR20) response was statistically significant in adult patients with active PsA every four weeks and every eight weeks in the treatment group Significance, reached the main endpoint of the trial.

In addition, in DISCOVER-1, the Tremfya group had a significant improvement in the quality of life scores of patients compared with the placebo group; in DISCOVER-2, the Tremfya group received every four weeks compared with the placebo group, and the patients' quality of life scores were significantly improved.
In the 24th week, the progression of imaging structural damage in the group receiving Tremfya every four weeks was significantly less than that in the placebo group, and the progression of structural damage in the measurement number of the group receiving Tremfya every eight weeks was also lower than that of the placebo group.
At 52 weeks, the average change in the total modified vdH-S score in the Tremfya group was similar to baseline.

In both studies, Tremfya was well tolerated, and the adverse events (AEs) observed were consistent with previous studies and current prescribing information.
In DISCOVER-2, less than 1% of patients developed severe infections after Tremfya treatment, and in DISCOVER-1, no patients developed severe infections after Tremfya treatment.
There were no reports of deaths among patients treated with Tremfya, and patients without Tremfya treatment developed inflammatory bowel disease, opportunistic infections (such as ringworm or Candida), active tuberculosis, or allergic or serological disease-like reactions.

The drug was first approved for the treatment of adults with moderate to severe plaque PsO in the United States in July 2017, and was approved for the treatment of adults with active PsA in July 2020.
Previously, NICE had recommended Tremfya for the treatment of eligible patients with moderate to severe plaque psoriasis.
Tremfya's FAD for the treatment of PsA will be used as the basis for the final technical assessment guide (TAG) issued to the NHS in England and Wales, which is expected to be released in June 2021.
(Sina Pharmaceutical News)

Reference source: NICE green lights Tremfya to treat active psoriatic arthritis