Ustekinumab (Stelara) is intended to be used for the treatment of psoriatic arthritis (PsA) in patients with structural joint damage after the failure of conventional disease modifying anti-rheumatic drugs (DMARDs). If licenced, it would provide an additional treatment option for this patient group. Ustekinumab is a human monoclonal antibody that targets the p40 subunit of interleukin-12 (IL-12) and interleukin-23 (IL-23), preventing their binding to receptors on T-cells and natural-killer cells. Ustekinumab is currently licensed in EU for the treatment of moderate to severe plaque psoriasis after failure of systemic therapies.
The prevalence of psoriasis in the general population is estimated at between 1.5-3%. The prevalence of inflammatory arthritis in people with psoriasis is estimated at ≤30%, however a prevalence of 50% has been recorded in some population studies. An estimated 5-10% of people with psoriasis and 25-40% of people with PsA have severe arthritis with progressive joint lesions. Joint damage has been shown radiologically in up to 47% of people with PsA at a median interval of 2 years. PsA can significantly affect the ability to work and to carry out daily tasks, which can have a substantial impact on quality of life. People with PsA have a 60% higher risk of mortality and their life expectancy is estimated to be reduced by approximately 3 years.
The clinical management of PsA includes physical therapy and a range of pharmacological treatments including DMARDs, such as methotrexate, and TNF alpha inhibitors. Ustekinumab is currently in two phase III clinical trials comparing its effect on ACR20 (a measure of improvement of arthritis) against treatment with placebo. These trials are expected to complete in 2012 and 2013.
There is currently no cure for rheumatoid arthritis. The most common treatment options are steroids to reduce inflammation, medications to reduce pain and inflammation and medications that slow the progression of joint damage from RA. Tocilizumab is already licensed for the treatment of RA as both intravenous and subcutaneous (pre-filled syringe) formulations, however its use, …