Briefing Note: ustekinumab (Stelara)

SMC accepted ustekinumab for use within NHSScotland for the treatment of moderate to severe plaque psoriasis in adults who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and psoralen and UVA treatment (PUVA).

• Psoriasis is a chronic skin disease which causes red, raised skin patches that produce dead, flaky skin cells. Plaque psoriasis is the most common type of this skin condition and can affect any part of the body. Symptoms include red, itchy and sometimes painful skin. The irritation is caused by a release of inflammatory substances that cause the blood vessels to widen and the area to become red, swollen and itchy.
• In psoriasis, certain immune cells (T cells) are triggered and become overactive. The T cells produce inflammatory chemicals, and act as if they were fighting an infection or healing a wound, which leads to the rapid growth of skin cells causing psoriatic plaques to form. Ustekinumab is a new treatment that slows down the inflammation. It is given as an injection at weeks 0 and 4 and then every 12 weeks afterwards. Treatment should be discontinued if patients have not shown any response after 28 weeks.
• In a study of patients treated with ustekinumab compared with an alternative treatment, significantly more patients achieved at least 75% improvement in their psoriasis.
• A condition known as injection site erythema was less frequent in those treated with ustekinumab. Rates of infections or serious infection were similar between both treatment groups.
• This SMC advice on ustekinumab takes account of the benefits of a patient access scheme (PAS). A PAS is a scheme proposed by a manufacturer in order to improve the cost effectiveness of a drug and enable patients to receive access to cost-effective new medicines.
• SMC accepted ustekinumab for use because, when the benefits of the PAS were included in the economic case, the manufacturer’s justification of the treatment’s health benefits in relation to its cost was favourable enough to gain acceptance. This SMC advice is dependent upon the continuing availability of the PAS in NHSScotland.