Products
Ustekinumab is commercially available as a solution for injection (Stelara). It was newly approved in the EU in January 2009, in the United States in September 2009, and in many countries in October 2010. In 2017, a concentrate for the preparation of an infusion solution was also approved. This article refers to subcutaneous administration.
Structure and properties
Ustekinumab is a human IgG1κ monoclonal antibody against the p40 subunit of interleukins IL-12 and IL-23.
Effects
Ustekinumab (ATC L04AC05) binds to and neutralizes the human cytokines interleukin-12 and interleukin-23, which play a role in the immune response and are thought to be partially responsible for the development of psoriasis. Ustekinumab thus has an immunosuppressive and anti-inflammatory effect.
Indications
For the treatment of adult patients with moderate-to-severe plaque psoriasis in whom other systemic therapies, including ciclosporin, methotrexate, or PUVA, have not responded, are contraindicated, or have not been tolerated. Ustekinumab has not yet been approved for the treatment of other autoimmune diseases.
Dosage
According to the SmPC. The drug is injected subcutaneously. The next injection follows 4 weeks later and then at 12-week intervals. These long intervals are possible because ustekinumab has a half-life of 15-32 days.
Contraindications
- Hypersensitivity
- Clinically relevant and active infection, such as tuberculosis.
Full precautions can be found in the drug label.
Interactions
Insufficient data are available on potential drug-drug interactions. Live vaccines should not be administered concomitantly.
Adverse effects
Ustekinumab has the potential to cause serious infections and increase the risk of developing malignancies. The most commonly observed adverse effects include respiratory infections, cellulitis, hypersensitivity reactions, depression, dizziness, headache, nasopharyngeal pain, nasal congestion, diarrhea, pruritus, back pain, muscle pain, fatigue, and local injection site reactions.
