Ustekinumab is a medication that has been specifically designed to mimic normal human molecules, and for this reason it is classed as a ‘biological’ drug. It helps reduce the skin inflammation by inhibiting the activity of chemical molecules known as cytokines (interleukin 12 and 23) in the body that trigger inflammation in psoriasis.
Role of an IL-12 & IL-23 inhibitor
- The cytokines IL-12 & IL-23 have a central role in the formation and maintenance of the inflammatory cascade in psoriatic diseases and have been demonstrated to be crucial targets for therapeutic interventions.
- Usteknumab 90 mg / 45 mg is a fully human monoclonal antibody which typically inhibits the activity of the cytokines IL-12 & IL-23.
- Rates of adverse events observed in the paediatric study were identical to those observed in the adult psoriasis population treated with Ustekinumab.
Indication
stelara is a biologic medicine which specifically blocks interleukin IL-12/23. It is used for the treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are not tolerant to other systemic therapies including PUVA, ciclosporin, and methotrexate (MTX). It is used for the treatment of moderate to severe plaque psoriasis in adolescents (aged 12 years or older) who are inadequately controlled by, or are not tolerant to, other systemic therapies or photo therapies. stelara 45 mg / 90 mg is also used for treatment of active psoriatic arthritis in adult patients, alone or along with MTX, when the response to prior non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Dosing, Storage and Handling
The proposed dosage of Ustekinumab is administered by a subcutaneous injection. To treat psoriasis, the recommended posology of Ustekinumab is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. To treat patients with a body weight >100 kg the initial dose is 90 mg which should be administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter.To treat psoriasis in adolescents (aged 12 years or older), the recommended dose is 0.75mg/kg for patients < 60kg, 45mg for patients ≥ 60kg–≤ 100kg, and 90mg for patients > 100kg.To treat psoriatic arthritis the recommended posology of Ustekinumab injection is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter. Alternatively, 90 mg may be prescribed in patients with a body weight > 100 kg.Ustekinumab should be administered at weeks 0 and 4, then every 12 weeks thereafter. Ustekinumab comes in a pre-filled syringe or vial and needs to be stored in a refrigerator between 2°C and 8°C and not frozen. Keep this medicine in its original outer packaging for protection from light and do not shake Ustekinumab. It should be allowed to reach room temperature (around half an hour out of the fridge) before administration. Ustekinumab is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein. Do not use Ustekinumab 45 mg injection or any other dosage strength in case the solution is discoloured or cloudy, or in case the foreign particulate matter exists.
Ustekinumab Efficacy & Safety
- Ustekinumab has demonstrated in clinical trials that it can provide patients with significant enhancements in their psoriasis and psoriatic arthritis, as measured by PASI and ACR scores.
- Psoriasis patients receiving Ustekinumab showed significant enhancement in skin symptoms (PASI 75 response) 12 weeks after initiating therapy. The maintenance of PASI 75 response has been shown in long term follow-up of up to 5 years in patients following the every-12-week dosing schedule.
- Psoriatic arthritis treatment with Ustekinumab 90 mg injection resulted in significant enhancements in the ACR20 score compared to placebo at Week 24. Efficacy was maintained through 12 months of continuous treatment with Ustekinumab. In addition, Ustekinumab-treated patients showed significant enhancement in physical function as assessed by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Week 24. The proportion of patients achieving a clinically meaningful ≥ 0.3 enhancement in HAQ-DI score from baseline was also significantly higher in the Ustekinumab groups when compared with placebo. Enhancements in physical function were maintained at 52'nd Week.
- Adverse events noted in trials of Ustekinumab include: nausea, fatigue, diarrhoea, dizziness, pruritus, headache, myalgia, back pain, arthralgia, oropharyngeal pain, upper respiratory tract infections, dental infections, nasopharyngitis, injection site erythema and injection site pain, antibodies to ustekinumab.
- The safety of ustekinumab has been evaluated in a phase-3 study of 110 patients from 12-17 years of age for up to 60 weeks. In this study, the adverse events reported were identical to those noted in previous studies in adults with plaque psoriasis.
Where can I get more information about ustekinumab?
This information sheet does not list all the details of ustekinumab. In case you want to know more about medicine ustekinumab, or in case you are a little bit worried about your treatment, you should speak to your health specialist. In depth, go through the medication information sheet which comes as an insert with the pack of ustekinumab.Alternatively,
