Skyrizi (risankizumab)
Skyrizi (risankizumab) is a medication used to treat adults with Plaque Psoriasis and Psoriatic Arthritis.
- Disease Indications : Psoriasis
- Manufacturer: AbbVie Ltd
- Usage : Subcutaneous
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Therapeutic Goods Administration (TGA)
Details
What is Skyrizi (risankizumab) for?
Skyrizi (risankizumab) is an interleukin-23 antagonist indicated to treat adults with:
- Plaque psoriasis that is moderate to severe in patients who are candidates for systemic therapy or phototherapy.
- Active psoriatic arthritis
It is available prefilled syringe and pen containing 150 mg/mL of risankizumab.
How does Skyrizi (risankizumab) work?
The active ingredient in Skyrizi, risankizumab, is a human monoclonal antibody, a type of protein, that binds to the cytokines interleukin (IL)-23. Cytokines play a role in signaling in a cell, especially in inflammation. Dysregulated production of and IL-23 were found to be very important in the development of specific diseases, such as psoriasis.
By binding to IL-23, tildrakizumab will block their action, and thereby slow down inflammation.
Where has Skyrizi (risankizumab) been approved?
Skyrizi (risankizumab) was approved by:
- The Food and Drug Administration (FDA), USA
- On April 23, 2019 to treat moderate to severe plaque psoriasis.
- On January 21, 2022 to treat active psoriatic arthritis.
- The European Medicines Agency (EMA)
- On April 26, 2019 to treat moderate to severe plaque psoriasis.
- On November 22, 2021 to treat active psoriatic arthritis.
- Therapeutic Goods Administration (TGA)
- On July 23, 2019 to treat moderate to severe plaque psoriasis.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team. /contact-us
How is Skyrizi (risankizumab) taken?
The standard dosage is:
- The first two doses of 150 mg are given 4 weeks apart
- The following doses are given every 12 weeks
Skyrizi is administered as an injection beneath the skin (subcutaneous).
Skyrizi can be taken in a treatment center or at home after you receive training from your doctor.
Complete information about Skyrizi (risankizumab) dosage (modification) and administration can be found in the official prescribing information listed in our references section.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Skyrizi (risankizumab)?
Common adverse reactions
The most common side effects (≥1% of patients) listed in the prescribing information include:
- Upper respiratory infections
- Headache
- Fatigue
- Injection site reactions
- Tinea infections
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Hypersensitivity reaction
- Infections
- Tuberculosis (TB)
Use in a specific population
Skyrizi (risankizumab) may harm your unborn baby when administered to a pregnant woman. Skyrizi may affect fertility in females and males who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- 1. Full prescribing information [FDA]: Skyrizi (risankizumab) [PDF] Novartis, Apr 2019
- 2. Targeting IL-23 in psoriasis: current perspectives Fotiadou C, Psoriasis (Auckl.), Jan 4, 2018
- 3. AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis FDA press release, Apr 2019
- 4. U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis FDA press release, Jan 2022
- 5. European Commission Approves SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis EMA press release, Apr 2019
- 6. AbbVie Expands Immunology Portfolio in the European Union with the European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis EMA press release, Nov 2021
- 7. AbbVie welcomes Therapeutic Goods Administration (TGA) - Regulatory Approval of SKYRIZI™ (risankizumab) [PDF] TGA press release, Jul 2019
Clinical trials
The Food and Drugs Administration (FDA) approval of Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis was based on data of four clinical studies: ultIMMa-1 (NCT02684370), ultIMMa-2 (NCT02684357), IMMhance (NCT02672852) and IMMvent (NCT02694523).
These four studies were randomized, placebo and/or active-controlled pivotal studies that involved a total of 2109 adults with moderate to severe plaque psoriasis.
In studies ultIMMa-1, ultIMMa-2 and IMMhance patients received either Skyrizi 150 mg or placebo at Weeks 0, 4, and every 12 weeks thereafter.
Results
The main study endpoint was the skin clearance, measured by the percentage of patients who achieved 90% improvement in Psoriasis Area and Severity Index (PASI 90) score and the percentage of patients who achieved a static Physician Global Assessment [sPGA] score of 0 (“clear”) or 1 (“almost clear”) at week 16.
3 out of 4 people achieved clearer skin within 16 weeks. In studies ultIMMa-1, ultIMMa-2, 75% of people treated with Skyrizi achieved PASI 90, compared to 5% and 2%, resp. receiving placebo. These people maintained this response for at least one year (88% and 80%, resp.).
88% and 84% of people receiving Skyrizi achieved a sPGA score of 0 or 1, versus 8% and 5% receiving placebo.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Skyrizi (risankizumab) for the approved indication.
References
- 1. AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis FDA press release, Apr 2019
- 2. BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis ultIMMa-1 study, cited May 2022
- 3. BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis ultIMMa-2 study, cited May 2022
- 4. BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment IMMhance study, cited May 2022
- 5. BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis IMMvent study, cited May 2022
- 6. Full prescribing information [FDA]: Skyrizi (risankizumab) [PDF] Novartis, Apr 2019
Price & Costs
Skyrizi (risankizumab) treatment costs
The cost for a monthly or yearly treatment of Skyrizi (risankizumab) depends on your prescription requirements which includes the dosage in mg/ml and medicine type (Pre-filled pen or syringe).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Skyrizi (risankizumab) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Skyrizi (risankizumab) price and additional costs
- The price of Skyrizi (risankizumab)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Skyrizi (risankizumab)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
everyone.org provides access to Skyrizi (risankizumab) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
When you buy Skyrizi (risankizumab), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Skyrizi (risankizumab) reimbursement
It might be possible for you to claim the cost of Skyrizi (risankizumab) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Shipping
Room temperature shipping
For this medication, standard shipping applies. This means that a consistent room temperature of 15 to 25°C is maintained during transit.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Our Process
Four steps to access the medicines you need
How and where to access and buy Skyrizi: You can access Skyrizi from everyone.org if the drug has not been approved or is not available in your country.
- Step 1: You send a request for your medicine online
- Step 2: We verify your prescription and medical details
- Step 3: We source your medicine
- Step 4: We deliver your medicine
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
Contact Patient Support
If you have any questions or need any help, contact our Patient Support Team. We will get in touch with you within 24 hours from Monday to Friday between 9:00 and 10:00 CET.
Email Address
Sshealthcare1012@gmail.com
+91 7575883015
Landline
079 48916267
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