Ustekinumab is recommended as an option for treating moderately to severely active Crohn’s disease in adults who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFalpha inhibitor (eg infliximab or adalimumab) or have medical contraindications to such therapies.
Ustekinumab (Stelara, Janssen) is a human monoclonal antibody that acts as a cytokine inhibitor by targeting interleukin12 (IL12) and interleukin23 (IL23).
Ustekinumab is given initially as a intravenous infusion (induction) and thereafter as a subcutaneous injection (maintenance):
• 1 intravenous induction treatment (about 6 mg/kg).
• Maintenance subcutaneous treatment at week 8 (90 mg), then every 12 weeks.
Ustekinumab is supplied as a sterile solution in a single-use pre-filled syringe and should be injected under the skin of the stomach, thighs or upper outer arms. A nurse will demonstrate how to inject yourself and details are also given in the drug package insert. It must be stored in a refrigerator (at 2-8 °C) and the vial must remain within the cardboard box to protect it from the light. Travelling with ustekinumab requires a cool box or cool bag with icepacks to maintain these temperatures. You will be provided with sharps bins so that you can dispose of your syringes and needles safely.
Mild and common
• Reactions at the injection sites. These are usually mild and include redness, a rash, swelling, itching, or bruising. They usually go away within 3 to 5 days. If you have pain, redness or swelling around the injection site that does not go away or gets worse, you should contact Dr Harris.
• Upper respiratory infections, for example, sinus infections (“nasopharyngitis”). Try to avoid close contact with anyone with a bad cold or chest infections, and wash your hands frequently when taking this medication.
• Headaches, dizziness, aching joints, rash, diarrhoea
• Serious infections. Ustekinumab may decrease your ability to fight infection. It must not be used in patients with TB, HIV or viral hepatitis, severe infections or abscesses. Contact your GP if you develop symptoms of infection such as fever, lethargy, a severe cough, influenza-like symptoms, warm, red or painful skin, swollen glands or open sores on your body.
• Allergic reactions. Some patients have had allergic reactions to ustekinumab. If you develop a severe rash, a swollen face, or have difficulty breathing while taking ustekinumab, attend a hospital A & E department and make sure that Dr Harris is informed.
• Latex allergy. Latex is present in the needle cover of the pre-filled syringe
Ustekinumab has not been used in pregnant women or nursing mothers, and so we do not know what its effects are on unborn children or babies who are being breast fed. You should avoid getting pregnant on this treatment. Please tell Dr Harris if you become pregnant or are thinking about becoming pregnant.
You should not receive any ‘live’ vaccines such as those for measles, mumps and rubella (German measles), yellow fever and polio. ‘Inactivated’ vaccines are safe, although they may not work as well if you are on a biological treatment such as ustekinumab.
If you require immunisation with a live vaccine, ustekinumab should be stopped for at least 6 months before and until 2 weeks after the vaccination. Pneumovax and annual influenza (including swine flu) vaccinations are safe and are recommended.
Results from the 2 large, randomised, placebo-controlled trials showed that 34-58% of patients treated with ustekinumab (about 6 mg/kg) had a significant clinical response by 6-8 weeks compared with 21-29% in those receiving placebo. The drug was more effective in patients who had not previously failed treatment with TNFalpha inhibitors (eg infliximab or adalimumab).
Of those who had a clinical response to ustekinumab and continued treatment every 12 weeks about 58% still had a clinical response by week 44 and about 50% were in clinical remission. It is important to note that these impressive results apply to those patients who responded to induction with ustekinumab.