NICE recommends Janssen’s active psoriatic arthritis drug

pharmafile | May 28, 2021 | News story | Medical Communications Janssen, NICE, UK, arthritis 

NICE have released a Final Appraisal Document (FAD) recommending Janssen’s tremfya (guselkumab) as a new option for treating active psoriatic arthritis (PsA) in adults who have not responded well to disease-modifying antirheumatic drug (DMARD) therapy or who cannot tolerate them.

The recommendation is only for patients if they have the following:

  • Peripheral arthritis with three or more tender joints and three or more swollen joints
  • Moderate to severe psoriasis (a body surface area of at least 3% affected by plaque psoriasis and a Psoriasis Area and Severity Index score greater than 10)
  • Had two conventional DMARDs and at least one biological DMARD

Guselkumab is the first approved fully human 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 of the progression of inflammatory diseases, including psoriasis and PsA, among others.

This recommendation is based on results from the DISCOVER-1 and DISCOVER-2 Phase III clinical trials, which assessed safety and efficacy of guselkumab at 100 mg dosed every eight weeks and every four weeks in adult patients with active PsA.

DISCOVER-1 evaluated 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 included 739 patients who were biologic-naïve only and had an inadequate response to standard therapies.

Amanda Cunnington, Patient Access and Health Affairs Director at Janssen-Cilag Limited, said: “Guselkumab 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.

“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.”

PsA is a progressive and multifaceted, chronic, immune-mediated, inflammatory disease. It is characterised by debilitating joint damage and inflammation in addition to enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. According to estimates, up to 123,000 people in the UK live with PsA and up to 30% of those who live with psoriasis may go on to develop PsA, but there is currently no known cure.

Dr James Galloway, Consultant Rheumatologist, Reader and Deputy Head of the Centre for Rheumatic Diseases at King’s College Hospital, said: “Psoriatic arthritis is a disease that can lead to severe disability and irreversible damage to joints. Guselkumab provides a new treatment option for eligible patients that offers both symptom control as well as protection from long term joint damage. The recent NICE announcement is welcome news indeed, and a great addition to our existing treatment toolkit.”

Guselkumab is already recommended by NICE as a clinical option for the treatment of eligible patients with moderate to severe plaque psoriasis. The FAD will form the basis of the final Technology Appraisal Guidance (TAG) issued to the NHS in England and Wales which is expected to be published in June 2021. Pending any appeals from key stakeholders, based on this positive recommendation, the NHS should make guselkumab available in England and Wales within three months of publication of the TAG.

Kat Jenkins

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