Janssen has announced that the National Institute for Health and Clinical Excellence (NICE), has recommended Stelara® (ustekinumab) in its Final Appraisal Determination (FAD)1 as a treatment option for patients with active psoriatic arthritis, when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.

According to the FAD, ustekinumab is recommended as an option, alone or in combination with methotrexate, for treating active psoriatic arthritis in adults only when:

  • treatment with tumour necrosis factor (TNF) alpha inhibitors is contraindicated but would otherwise be considered or
  • the person has had treatment with 1 or more TNF-alpha inhibitors.

Psoriasis affects an estimated 1.8 million people in the UK, approximately 2-3 percent of the population.2 Among patients with psoriasis, the prevalence of psoriatic arthritis, a chronic immune-mediated disease characterised by joint inflammation3, varies from 6% to 42%. Psoriatic arthritis can also occur in people without skin psoriasis, although this is less common.4 The condition can have a significant negative impact on patient mobility, psychological well-being and quality of life.3

"This is a welcome recommendation from NICE and it is encouraging to hear that patients with active psoriatic arthritis should have access to ustekinumab through the NHS. Psoriatic arthritis has several different variants with genetic and laboratory studies indicating that the part of the immune system that is often abnormally regulated in disease is directly targeted by ustekinumab." commented Professor Dennis McGonagle, Honorary Consultant Rheumatologist, Leeds NHS Trust Teaching Hospitals. "We know that it is an effective treatment option, which works in a different way to other licensed therapies. The ability to prescribe varied treatment options is of the utmost importance when managing patients with active psoriatic arthritis, given that so many patients struggle to find a treatment which works for them with some patients also experiencing toxicities from the available treatments. Today marks an important step in ensuring that the NHS can improve the quality of life of patients with psoriatic arthritis" he continued.

Ustekinumab is a treatment with a unique mode of action which works by altering a specific part of the body's immune system response thought to be linked to the development of psoriasis and psoriatic arthritis.5

Janssen has completed a comprehensive clinical trial programme to establish the efficacy and long-term tolerability profile of ustekinumab in psoriatic arthritis, with one of the biggest biologic trials to date in this indication, involving over 900 patients.

"We are delighted with today's recommendation from NICE. We know that people living with psoriatic arthritis are in real need of additional treatment choices that can help them manage a debilitating and often painful condition. Ustekinumab could have a marked positive impact on the quality of life for many of these patients living with active psoriatic arthritis and represents an important additional treatment option for this condition," commented Peter Barnes, Medical Director at Janssen UK.

The most common adverse reactions (> 5%) in the controlled periods of the psoriasis and psoriatic arthritis clinical studies with ustekinumab were nasopharyngitis, headache and upper respiratory tract infection. Most were considered to be mild and did not necessitate discontinuation of study treatment. For further information please refer to the Summary of Product Characteristics.6

The Janssen Immunology team is working together with academia and biotechnology institutes to continue developing new, tailored therapeutic options that ultimately aim to provide the right treatment for the right person at the right time.

About Psoriatic Arthritis

Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis. Psoriasis affects an estimated 1.8 million people in the UK, approximately 2-3 percent of the population.2 Among patients with psoriasis the prevalence of psoriatic arthritis varies from 6% to 42%.4 Psoriatic arthritis can also occur in people without skin psoriasis, although this is less common.4 Though the exact cause of psoriatic arthritis is unknown, genetic susceptibility, changes in the immune system and environmental factors are all believed to play a role in the onset of the disease.6, 7

About ustekinumab

Ustekinumab is a human monoclonal antibody with a novel mechanism of action that targets the p40 sub-unit of two cytokines, interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating immune responses and that are thought to be associated with immune- mediated inflammatory disorders, including plaque psoriasis. Ustekinumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate or PUVA. It is also indicated alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.8

In September 2013, the European Commission approved the use of ustekinumab, alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Ustekinumab was previously approved by the European Commission for moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) in January 2009.

In the treatment of psoriatic arthritis, the recommended dosing regimen for adults and the elderly (≥ 65 years) is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may be used in patients with a body weight >100 kg.8

The safety data described below reflect exposure to ustekinumab in 7 controlled phase 2 and 3 studies of 4,135 patients with psoriasis and/or psoriatic arthritis, including 3,256 exposed for at least 6 months, 1,482 exposed for at least 4 years, and 838 exposed for at least 5 years.8

The most common adverse reactions (> 5%) in controlled periods of the psoriasis and psoriatic arthritis clinical studies with ustekinumab were nasopharyngitis, headache and upper respiratory tract infection. Most were considered to be mild and did not necessitate discontinuation of study treatment. The most serious adverse reaction that has been reported for ustekinumab is serious hypersensitivity reactions including anaphylaxis.8

The Summary of Product Characteristics for ustekinumab, which includes safety information, can be found on the eMC website here.