Janssen has announced that the National Institute for Health and Clinical Excellence (NICE), has recommended Stelara® (ustekinumab) in its definitive Technology Appraisal Guidance (TAG)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 TAG, 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.1

Treatment with ustekinumab should be stopped after 24 weeks if it is not working well enough. Ustekinumab is recommended only if the company provides the 90 mg dose of ustekinumab for people who weigh more than 100 kg at the same cost as the 45 mg dose, as agreed in the patient access scheme.1

"This is a newly reimbursed class of drug to treat psoriatic arthritis, with a strong mechanistic link to the underlying disease process and it is clearly effective," commented Professor Dennis McGonagle, Professor of Investigative Rheumatology, Leeds Institute of Rheumatic and Musculoskeletal Medicine. "It's great to have another option for our patients who we currently find challenging to treat, either because they are failing on existing treatments or because the existing therapies are contraindicated or causing undesirable side effects," he said.

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 inflammation, varies from 6% to 42%.3 Psoriatic arthritis can also occur in people without skin psoriasis, although this is less common.3 The condition can have a significant negative impact on patient mobility, psychological well-being and quality of life.4

"Ustekinumab is already reimbursed under a patient access scheme for suitable adults with severe plaque psoriasis and this is welcome news that ustekinumab will now also be reimbursed for eligible psoriatic arthritis patients," comments Rozlyn Bekker, Medical Director at Janssen UK ."It means that ustekinumab has the potential to contribute towards an improved quality of life for patients living with this often painful and debilitating disease" she continues.

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.

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

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%.3 Psoriatic arthritis can also occur in people without skin psoriasis, although this is less common.3 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.7,8

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.6

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.6

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.6

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.6

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