NICE ( National Institute for Health and Care Excellence ) has published final guidance today which does not recommend Ustekinumab ( Stelara ) for psoriatic arthritis.
Psoriatic arthritis is an inflammatory disease affecting the joints and connective tissue, and is associated with psoriasis of the skin or nails. It is a progressive disorder, ranging from mild synovitis ( inflammation of the tissue lining joints such as the hip or shoulder ) to severe progressive erosion of the joints.
The Independent Appraisal Committee examined the clinical and cost effectiveness of using Ustekinumab alone or in combination with Methotrexate, for treating active psoriatic arthritis in adults when the response to previous non-biological disease-modifying antirheumatic drug ( DMARD ) therapy has been inadequate.
The Committee accepted that Ustekinumab is clinically effective compared with conventional DMARD treatment, but the Committee concluded that Ustekinumab appeared less effective than TNF alpha inhibitors.
The Committee also noted that the economic analyses found that Ustekinumab was not a cost-effective option.
Whilst recognising the severity of the disease, the Committee concluded that Ustekinumab could not be considered a good use of NHS resources.
NICE currently recommends Golimumab, Adalimumab, Etanercept and Infliximab for treating active and progressive psoriatic arthritis in adults.
Ustekinumab is a monoclonal antibody ( a biological therapy designed to recognise and attach to specific proteins on the surface of cells ). It acts as a cytokine inhibitor ( blocker of molecular messages ) by targeting interleukin-12 ( IL-12 ) and interleukin-23 ( IL-23 ) ( interleukins are proteins produced by white blood cells for regulating immune responses ).
Ustekinumab is administered by subcutaneous injection. The recommended dose of Ustekinumab is an initial dose of 45 mg, followed by a dose 4 weeks later and further doses every 12 weeks thereafter. A dose of 90 mg may be used in people with a body weight over 100 kg.
The summary of product characteristics notes that consideration should be given to discontinuing treatment in people whose psoriatic arthritis has shown no response after up to 28 weeks of treatment. ( Xagena )
Source: NICE, 2014