Stelara (ustekinumab)

Stelara has been approved by Health Canada in December 2008 for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It was subsequently approved for psoriatic arthritis and then for adolescents 12 years old and older and Crohn’s disease.

How Does It Work?

Stelara is an approved fully human monoclonal antibody that binds and neutralizes a messenger protein called IL-12 and IL-23; more specifically it’s shared p40 subunit, which is involved in the development of psoriasis. By blocking the effect of p40, Stelara prevents the body’s autoimmune attack against the skin of those suffering from psoriasis and psoriatic arthritis and Crohn’s disease.

How Is it Administered?

Stelara is given as an injection under the skin. The first injection is at week 0 (the first week of treatment) and week 4, and then every 12 weeks afterwards. The recommended starting dose of Stelara is 45 mg for individuals weighing 220 lbs (100 kg) or less, and 90 mg for those who weigh more than 220 lbs. The dose can be given more often such as every 8 weeks if necessary after discussion with your doctor. It must be used continuously for effectiveness.

A single-use vial and pre-filled syringe is available.

What are its Side Effects?

Since it is a biologic treatment that suppresses your immune system, patients taking it have a higher chance of catching an infection. Prior to starting treatment with Stelara, your doctor will evaluate you for a tuberculosis infection. Those who have a current TB infection cannot start Stelara.

The most frequently reported adverse reaction were mild-moderate upper respiratory infections (e.g.: a runny nose or sore throat).

Special Populations and Stelara

  • Latex Allergy: Patients who have a latex-sensitivity may react to the removable cap on the Stelara pre-filled syringe, which contains a derivative of natural rubber latex.
  • Pregnant Women: there are no adequate clinical trials on the use of Stelara during pregnancy, however animal studies did not show any harmful effects in pregnancy. The current recommendation is use Stelara during pregnancy only if the benefit justifies the potential risk to the fetus.
  • Nursing women: It is not known whether Stelara is excreted in human milk, so caution should be exercised when taking it while nursing.
  • Fertility: The effects on human fertility have not been evaluated. However, animal studies did not indicate any harmful effects on fertility.
  • Kids < 12 years old: The safety and efficacy of Stelara in paediatric patients have not been studied yet, so for this patient population, Stelara is not recommended.
  • Elderly patients >65 years old: Limited studies suggest that there is no difference in safety and efficacy between older and younger patients.
  • Kidney/Liver Impairment: Stelara has not been studied in these patient populations.

What medications should I pay attention to when on Stelara?

  • Stelara suppresses your immune system’s response to infection, which prevents it from releasing your body’s “fighter cells” that help you build an immunity to components of vaccines. For this reason, patients on Stelara (and other biologic medications) cannot have any live vaccine given to them. Some examples are: Influenza nasal vaccine, MMR, Rotavirus, Smallpox, Varicella/Zoster, Yellow Fever, Thyphoid.
  • You can and should, however, receive inactivated or non-live vaccinations, such as the yearly influenza vaccine (injectable) and the meningococcal vaccine. Data suggest that Stelara does not suppress your immune system’s response to either of these vaccines.

For detailed information on side effects, safety and if this medication is right for you, please speak to your doctor.

Download Stelara patient information here

Read more about the BioAdvance patient support program for Stelara