How you can be Autoimmunity Symptoms-free with SKYRIZI.

Chronic inflammatory diseases like Psoriasis, Psoriatic Arthritis, and Inflammatory Bowel Disease (IBD) can significantly impact a person’s quality of life. These conditions arise from an overactive immune response, leading to persistent inflammation and a range of exhausting symptoms.

Plaque psoriasis, the most common form of psoriasis, affects over 125 million people worldwide.1 It manifests as raised, red, scaly patches on the skin due to an accelerated skin cell turnover process.2 Psoriatic arthritis, a related autoimmune disorder, not only causes joint pain and stiffness but also leads to irreversible joint damage if left untreated.3

IBD, which includes Crohn’s disease and ulcerative colitis, affects the digestive tract and results in chronic abdominal pain, diarrhea, and malnutrition. Crohn’s disease can cause inflammation anywhere along the gastrointestinal tract, while ulcerative colitis primarily affects the colon and rectum.4 Managing these conditions requires targeted therapies that can modulate the immune response and reduce inflammation, improving long-term outcomes for patients.

Skyrizi (Risankizumab) is a fairly recent innovation in the vast and confusing world of autoimmune disease management. When most therapies have failed to provide satisfactory results, Skyrizi seems to have cracked the code with certain autoimmune diseases.5 It received its first FDA approval in April 2019 for management of Plaque Psoriasis and has since received approval for a few more diseases. Risankizumab is approved for medical use in the European Union,6 the United States,7 Canada,8 and Japan.9

Let’s have a deeper insight into the diseases SKYRIZI helps with:

Crohn’s disease:
Crohn’s is an auto-immune condition wherein the body’s immune system attacks healthy tissue in the gastrointestinal tract leading to chronic inflammation- it commonly affects the small and large intestines. Although not usually life-threatening, patients with Crohn’s have a painful experience with its symptoms such as abdominal pain, chronic diarrhea, rectal bleeding (bloody stools) infections around the anus as well as mouth ulcers etc.4 Based on its severity, Crohn’s can be mild, moderate or severe. Diagnosis- A trained medical professional, usually a gastroenterologist will make a diagnosis based on history of these symptoms, blood & stool tests and a colonoscopy.4

Ulcerative colitis: UC is an autoimmune related disease that causes ulcers and inflammation in the lining of the colon and rectum (parts of the large intestine) UC is usually not fatal but patients tend to undergo severe discomfort and pain. Common symptoms include abdominal cramps, pus and blood in stools, diarrhea, anemia, severe tiredness. In severe cases, the colon may have to be surgically removed too10 Diagnosis- A trained medical professional, usually a gastroenterologist will make a diagnosis based on history of these symptoms and a colonoscopy.10
Plaque psoriasis: The most common kind of psoriasis- an autoimmune disorder of the skin that appears as raised, red patches of skin that are covered by silver scales. The patches usually develop in a symmetrical pattern on the body and tend to appear on the scalp, trunk, and limbs, especially the elbows and knees.2 PS can be graded mild, moderate and severe. About 15% of patients will present with arthritis of the small joints 11. Diagnosis- Plaque psoriasis is diagnosed based on family history, examination of these symptoms, a skin biopsy maybe indicated to rule out other skin diseases like eczema.11
Psoriatic arthritis: PA is a progressive inflammatory condition of the joints and the places where tendons and ligaments attach to the bone(entheses). As diseases described above, PA follows a similar course- the body’s immune system, becomes overactive and creates inflammation, leading to pain and swelling. Most people who develop PA already have psoriasis of the skin that presents with itchy patches or scales on the skin, especially the knees, elbows, and scalp.3 . Diagnosis- Primarily done through a physical examination for tender/swollen joints & skin for psoriatic lesions. Blood tests maybe indicated to rule out rheumatoid arthritis. MRI scans & X-rays and ultrasounds are also useful tools in diagnosis and revealing the condition of joints & tendons.3

What causes these diseases?

While the exact cause of these diseases remains unknown, we do know quite a bit about what happens when they occur in the body and hence, how to manage them effectively.

Here’s a brief look at it:

Immune-mediated inflammatory diseases such as psoriasis are linked to interleukin activity.11

Interleukins (ILs) are a group of proteins that act as messengers between cells, regulating immune responses. They are a type of cytokine, a larger group of proteins that help the immune system communicate. 13

Interleukins, particularly IL-17 and IL-23, are key cytokines that contribute to the development of psoriasis by triggering a cascade of inflammatory responses, leading to excessive skin cell growth and the characteristic thickened skin plaques seen in psoriasis14

Similarly, IL-22 IL-23 etcetera play a key role in triggering an inflammatory response in the colon that damages the intestinal lining which leads to ulcerative colitis 15

How does Skyrizi work?

Simply put- Skyrizi is an anti-interleukin therapy. 16

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. Since it does not let IL-23 bind to its receptor- the subsequent signalling that triggers inflammation- is then controlled. 16

How is it used?

Use SKYRIZI exactly as your healthcare provider tells you to use it.
Skyrizi is administered by subcutaneous injections or intravenous infusions.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. 17
Adults with plaque psoriasis or psoriatic arthritis will receive SKYRIZI as an injection under the skin (subcutaneous injection) using the prefilled pen or prefilled syringe. 18
Adults with Crohn’s disease or ulcerative colitis receive their starter doses with SKYRIZI through an IV via a vein in their arm (intravenous infusion) by their healthcare provider. 18
After completing the starter doses, patients will receive SKYRIZI as 1 or more injections under the skin (subcutaneous injection) which is administered by prefilled cartridges or prefilled syringes.18

Dosage

While the diagnosis and dosage of SKYRIZI is decided by the healthcare provider, the recommended dosages are as follows: 18

Plaque Psoriasis and Psoriatic Arthritis: 150 mg administered by subcutaneous injection (under the skin) at Week 0, Week 4, and every 12 weeks thereafter.
In patients with psoriatic arthritis SKYRIZI can be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).
Crohn’s Disease: The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg which is given by subcutaneous injection at Week 12, and there onwards it is repeated every 8 weeks. Lowest effective dosage is used to maintain the therapeutic response.
Ulcerative Colitis: The recommended induction dosage is 1200 mg administered by intravenous infusion over at least two hours at Week 0, Week 4, and Week 8.

The recommended dosage for maintenance is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Lowest effective dosage is used to maintain therapeutic response.

Few things to keep in mind:

Hepatotoxicity: For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment 19
Tuberculosis: Patients should be evaluated for TB during and after SKYRIZI treatment. 18
Immunizations: Make sure you are up to date with all the recommended age- appropriate vaccinations before starting SKYRIZI, as it is not advised to administer live vaccinations while receiving SKYRIZI treatment. 18
Storage: Do not freeze. After preparation or removal from refrigeration, the diluted SKYRIZI solution can be stored at room temperature at up to 25°C (protected from sunlight) for 4 hours (cumulative time from start of dilution to start of infusion). 20
Correct technique: Patients using the on-body pre-filled pen should be trained to do so by their physicians, avoid injecting on red/tender skin or skin affected by psoriasis. Let the injection reach room temperature to avoid discomfort.

Missed dosage: If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time. 18

Prompt reporting & follow-ups: In any incident of an allergic reaction or other side effects, the doctor should be immediately notified & necessary care should be prioritized.

Warnings, Precautions & Side effects- What to expect?

Allergic reactions: Do not use SKYRIZI if you are allergic to the medicine or any of the excipient ingredients, severe hypersensitivity reactions including anaphylaxis have been reported with SKYRIZI, immediately stop the treatment and provide medical attention in any event of such a reaction. 18
Infections: SKYRIZI may increase the risk of infections, especially Upper-respiratory tract infections and tinea infections. Monitor closely for any signs of infections- cold, fever, fatigue etcetera. Possibility of TB should be ruled out & patient should be regularly monitored for any signs of TB.
Hepatotoxicity: In Treatment of Inflammatory Bowel Disease- Drug induced liver injury during induction has been reported. Monitor liver enzymes and bilirubin levels at baseline and, during induction, up to at least 12 weeks of treatment 19

How long does it take for SKYRIZI to start working?

It is important to note that individual results may vary & your doctor can give you a more accurate idea of how SKYRIZI should work for you.

Skyrizi starts working after your first dose. Studies 21 show that some people had their symptoms reduced in the following time frames:

For plaque psoriasis: after 16 weeks of treatment
For psoriatic arthritis: after 16 weeks of treatment
For Crohn’s disease: within 8 weeks of starting treatment
For ulcerative colitis: after 12 weeks of treatment

Documents required to import SKYRIZI to India:

SKYRIZI (Risankizumab-rzaa) Injection can be imported by patients or treating physicians on behalf of patients.

The following documents are required to import SKYRIZI:

2 ID proofs along with PAN card details along with attested scanned copies
Valid doctor prescription scanned copy
Doctor’s MCI number
Doctor’s contact number
Patient’s diagnostic reports

In Conclusion: Skyrizi is a newer, and better solution to certain autoimmune diseases owing to its unique qualities that distinguish it from other medicines such as HUMIRA in terms of dosage frequency & fewer reported side effects 18. Skyrizi is a more specific drug as it blocks only IL-23 distinguishing it from other anti-interleukin therapies such as STELARA. Skyrizi is approved for use in Europe 6, USA 7, Canada8, Japan 9 and Australia 23 It offers patients with rare diseases like Crohn’s and Psoriasis- a remarkable opportunity to induce remission and maintain it too.

Your Health, Our Mission

Accessing rare disease medicines can be challenging for those battling rare conditions with a few treatment options. Platforms like Rx4u bridge this gap, sourcing hard-to-find therapies that could be life-changing. The team at Rx4u has extensive experience in sourcing SKYRIZI from around the world, ensuring global access to the best available treatments for our customers. We are dedicated to promptly dispensing valid prescriptions. All prescriptions are verified and are dispatched directly to the patient’s address. We prioritize our and streamline the access and dedicated support, to help bring hope and healing when it matters most.

Ref:

https://autoimmune.org/disease-information/ulcerative-colitis-uc/#:~:text=What%20is%20Ulcerative%20colitis%20(UC,doctors%20must%20remove%20the%20colon

https://www.abbvie.com.au/content/abbvie-com/au/en/media/skyrizi-for-psoriatic-arthritis.html#:~:text=SYDNEY%2C%20AUSTRALIA%2C%2016%20MAY%202022,%2Drheumatic%20drugs%20(DMARDs).

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