Have you ever thought about a single medicine treating many autoimmune diseases? Stelara is a groundbreaking biologic drug changing the game for treating complex autoimmune disorders. It helps with plaque psoriasis, Crohn’s disease, and more, offering relief from chronic symptoms.
Key Takeaways
- Stelara is a biologic drug prescribed for several autoimmune conditions, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
- The active ingredient in Stelara is ustekinumab, a monoclonal antibody that targets specific proteins involved in the body’s inflammatory response.
- Stelara is available in the form of a subcutaneous injection and an intravenous (IV) infusion, and it is FDA-approved to treat moderate to severe cases of these autoimmune conditions in both adults and children ages 6 and older.
- Stelara has been shown to be effective in reducing symptoms and inducing remission in various autoimmune conditions, with the specific effectiveness varying depending on the condition and clinical trial data.
- Patients and healthcare providers should be aware of the potential side effects, both common and serious, associated with Stelara, as well as proper storage and handling requirements.
What is Stelara?
Stelara is a prescription drug with ustekinumab as its main ingredient. It’s a monoclonal antibody, a special kind of biologic medication. Ustekinumab targets and blocks two proteins, interleukin-12 (IL-12) and interleukin-23 (IL-23). These proteins are key in the body’s inflammatory response.
By stopping these proteins, Stelara cuts down inflammation. This helps ease symptoms of autoimmune conditions.
Active Ingredient: Ustekinumab
The main part of Stelara is ustekinumab, a monoclonal antibody. The FDA has approved it for treating several autoimmune diseases. These include ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Mechanism of Action
Ustekinumab blocks the action of IL-12 and IL-23, two important proteins. These proteins are key in the body’s inflammatory response. By stopping them, Stelara reduces inflammation in autoimmune conditions.
This leads to better symptoms and disease management.
| Key Mechanisms of Stelara | Description |
|---|---|
| Targets IL-12 and IL-23 proteins | Ustekinumab, the active ingredient in Stelara, blocks the action of IL-12 and IL-23, which are involved in the body’s inflammatory response. |
| Reduces inflammation | By neutralizing IL-12 and IL-23, Stelara helps lower inflammation associated with autoimmune conditions. |
| Improves symptoms | The reduced inflammation leads to improved symptoms and better management of autoimmune diseases like ulcerative colitis, plaque psoriasis, and psoriatic arthritis. |
Stelara Shot for Plaque Psoriasis
Stelara is a biologic treatment approved by the FDA for plaque psoriasis in adults and kids as young as 6. Studies show it works well for this condition.
Effectiveness in Clinical Trials
After 12 weeks, up to 73% of adults and 70% of teens saw a big drop in skin plaques. This is compared to 4-5% on a placebo. Also, 76% of adults and 80.6% of teens got at least a 75% betterment in psoriasis symptoms.
“In clinical trials, 60% of plaque psoriasis patients achieved clear or nearly clear skin after 12 weeks of using Stelara. 70% of patients experienced at least a 75% improvement in plaque psoriasis symptoms after 12 weeks of treatment with Stelara.”
Stelara is a strong biologic treatment for moderate to severe psoriasis. It targets the immune system to reduce inflammation and clear skin plaques. This brings a lot of relief to those with this chronic condition.
Stelara Shot for Psoriatic Arthritis
Stelara is a biologic medication approved by the FDA for psoriatic arthritis. It works for adults and kids as young as 6. This condition causes skin plaques and joint pain. Studies show Stelara helps both adults and kids with psoriatic arthritis symptoms.
After 6 months, up to 50% of adults saw a big improvement in joint pain. This is compared to 23% on a placebo. Stelara really helps with joint pain in psoriatic arthritis.
| Treatment | Improvement in Painful/Swollen Joints |
|---|---|
| Stelara | 50% |
| Placebo | 23% |
The dose for psoriatic arthritis is 45 mg at first and then 4 weeks later. After that, most patients get 45 mg every 12 weeks. For those with plaque psoriasis and weigh over 220 lbs, the dose is 90 mg initially and then 90 mg every 12 weeks.
Stelara comes in 45 mg and 90 mg syringes and 45 mg vials. It’s a subcutaneous injection that patients can do themselves with training. This means Stelara is injected less often than other biologic treatments for psoriatic arthritis.
“Stelara is a game-changer for many patients with psoriatic arthritis, offering significant relief from both skin and joint symptoms with a convenient dosing schedule.”
Stelara Shot for Crohn’s Disease
Crohn’s disease is a chronic inflammation of the gut. The Stelara biologic treatment has been approved by the FDA for adults with moderate to severe Crohn’s disease. It has shown promise in reducing symptoms.
Reducing Crohn’s Symptoms
Stelara has been effective in helping Crohn’s disease patients. The treatment involves an initial dose based on body weight, followed by a maintenance dose of 90mg every 8 weeks. This is given as a subcutaneous injection.
Some patients see an improvement in symptoms within 3 weeks of starting Stelara. However, it may take up to 8 weeks for full symptom reduction. By week 44, nearly half of the patients experienced remission, as shown by a lower Crohn’s Disease Activity Index (CDAI) score.
Stelara is for adults who have not responded to other treatments. Before starting, consider recent vaccinations, history of cancer, current infections, and allergic reactions.
| Medication | Approved for Crohn’s Disease | Dosing Regimen | Potential Side Effects |
|---|---|---|---|
| Stelara (ustekinumab) | Yes, for moderate to severe Crohn’s disease in adults | Induction dose based on body weight, followed by 90mg every 8 weeks subcutaneously | Infections, certain cancers, allergic reactions, lung inflammation |
| Remicade (infliximab) | Yes, for moderate to severe Crohn’s disease | 5mg/kg IV infusion at 0, 2, and 6 weeks, then every 8 weeks | Infections, certain cancers, heart failure, autoimmune conditions |
The cost of Stelara treatment for Crohn’s disease varies. It depends on insurance, pharmacy, and location. Working with healthcare providers is key to finding an affordable treatment plan.
Stelara Shot for Ulcerative Colitis
Ulcerative colitis is a type of inflammatory bowel disease. It causes inflammation and symptoms like abdominal pain and bloody diarrhea. Stelara (ustekinumab) is FDA-approved to treat moderate to severe ulcerative colitis in adults.
Clinical studies show Stelara’s effectiveness in managing ulcerative colitis. Most patients felt better after just one IV infusion within 8 weeks. About 1 in 5 patients went into remission after the first IV dose. And 4 out of 10 patients stayed in remission for up to 1 year with ongoing treatment.
Stelara offers long-term benefits for ulcerative colitis patients. Most patients had no rectal bleeding and fewer bowel movements after 4 years of treatment. It also reduced inflammation in the intestines. By 8 weeks, 17% of patients saw this effect, increasing to 44% at 1 year.
Stelara targets the interleukin-12 (IL-12) and interleukin-23 (IL-23) proteins involved in inflammation. It starts with an IV infusion, then subcutaneous injections every 8 weeks. Over 22,000 ulcerative colitis patients and over 121,000 Crohn’s disease patients have been treated with Stelara in the US.
| Key Stelara Statistics for Ulcerative Colitis | Value |
|---|---|
| Patients achieving remission after initial IV dose | Approximately 1 in 5 patients |
| Patients maintaining remission at 1 year | 4 out of 10 patients |
| Patients with reduced intestinal inflammation at 1 year | 44% of patients |
| Estimated number of ulcerative colitis patients treated with Stelara in the US | Over 22,000 |
Stelara is a proven biologic treatment for adults with moderate to severe ulcerative colitis. It helps alleviate symptoms, achieve remission, and reduce inflammation in the digestive tract.
Off-Label Uses of Stelara
Stelara (ustekinumab) is mainly used for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. But, it also shows promise for treating other autoimmune conditions off-label. Research is looking into its use for ankylosing spondylitis and systemic lupus erythematosus (lupus).
Ankylosing Spondylitis
Ankylosing spondylitis mainly affects the spine, causing chronic inflammation and stiffness. Early studies suggest Stelara might help reduce symptoms. But, more recent, larger studies found it not to be more effective than a placebo.
Lupus
Systemic lupus erythematosus, or lupus, can harm many organs and tissues. Stelara is sometimes used off-label for lupus symptoms. Yet, the evidence for its effectiveness is still limited. More research is needed to see if Stelara is a good treatment for lupus.
It’s important to remember that Stelara is not approved or recommended for rheumatoid arthritis. Studies have shown it’s not effective for this condition.
| Condition | Efficacy of Stelara |
|---|---|
| Ankylosing Spondylitis | Mixed results in smaller studies, not more effective than placebo in larger studies |
| Systemic Lupus Erythematosus (Lupus) | Limited evidence for efficacy, further research needed |
| Rheumatoid Arthritis | Not effective, not recommended |
Stelara might help with some off-label autoimmune conditions, but its use is still experimental. Healthcare professionals should closely monitor its use. The benefits and risks must be weighed for each patient.
Psoriasis causes as much disability as other major medical diseases.
Stelara Shot: Administration and Dosage
Stelara is a biologic medication for treating autoimmune conditions. It comes in two forms: subcutaneous injection and intravenous (IV) infusion. The right method and dosage depend on the condition being treated.
Subcutaneous Injection
The first Stelara dose is two 45 mg injections. These are given in the thigh, buttocks, or abdomen, but not near the belly button. After that, doses are given every 8 or 12 weeks, depending on the condition.
Intravenous Infusion
Stelara can also be given through an IV infusion, especially at the start. This is followed by subcutaneous injections for ongoing treatment.
It’s vital to have a healthcare professional administer Stelara. Those giving injections at home will get detailed instructions on how to do it right.
Dosage Considerations
- Stelara comes in prefilled syringes with 45 mg or 90 mg per 0.5 mL for subcutaneous use.
- For a 90 mg dose, two 45 mg syringes are used, given one after the other.
- The dosage and how often it’s given can change based on the condition, the patient’s weight, and how well they respond to treatment.
- Patients should always follow their healthcare provider’s instructions and not take more Stelara than prescribed.
It’s important to store and handle Stelara properly. Patients must check that the medication is not past its expiration date before using it. With the help of their healthcare team, patients can manage their Stelara treatment safely and effectively.
Potential Side Effects of Stelara
The Stelara shot (ustekinumab) can cause both mild and serious side effects. It’s important for patients to know about these risks before starting treatment for autoimmune conditions.
Common Side Effects
The most common side effects of Stelara include:
- Injection site reactions, such as bruising, itching, pain, redness, swelling, or hardening
- Fatigue
- Headache
- Upper respiratory infections
These mild side effects usually go away within a day or two.
Serious Side Effects
Stelara can also cause serious side effects that need immediate medical attention:
- Serious infections, such as pneumonia, tuberculosis, or sepsis
- Posterior reversible encephalopathy syndrome (PRES), a rare condition that can cause swelling in the brain and neurological symptoms
- Lung problems, including persistent cough or shortness of breath
- Allergic reactions, with symptoms like rash, swelling, or difficulty breathing
- Increased risk of certain types of cancer, such as nonmelanoma skin cancer
Patients should tell their healthcare provider about any concerning side effects right away.
For most patients, the benefits of Stelara outweigh the risks. But, it’s crucial to watch for stelara side effects and follow the safety advice from healthcare professionals.
Storing and Handling Stelara
Storing and handling Stelara correctly is key for its effectiveness and safety. It comes in prefilled syringes and vials. Following specific guidelines is important to keep it potent and sterile.
Stelara storage requirements:
- Stelara prefilled syringes and vials must be stored in a refrigerator between 36-46°F (2-8°C).
- The medication should be kept in the original carton to protect it from light.
- Stelara should never be frozen or shaken, as this can compromise the medication’s integrity.
If needed, a Stelara prefilled syringe may be stored at room temperature up to 86°F (30°C) for up to 30 days. But, it cannot be returned to the refrigerator after being stored at room temperature. Any unused Stelara past the expiration date should be discarded properly.
| Storage Condition | Maximum Storage Time |
|---|---|
| Refrigerator (36-46°F/2-8°C) | Until the expiration date |
| Room Temperature (up to 86°F/30°C) | 30 days |
After administering a subcutaneous injection of Stelara, used syringes should be disposed of in a sharps container. This ensures proper and safe disposal of medical waste.
By following these guidelines for stelara storage and medication handling, patients can help maintain the proper storage of their Stelara medication. This ensures its efficacy for treating autoimmune conditions.
Stelara for Children and Adolescents
The Stelara shot is a good option for young patients with autoimmune conditions. Stelara is approved for kids aged 6 and up. It helps with plaque psoriasis or psoriatic arthritis.
Studies show Stelara works well for kids. In the CADMUS study, most patients saw big improvements. They got better scores on their skin and joints.
Stelara is safe for kids and teens too. In the CADMUS study, most side effects were mild and short-lived. Common issues in older kids were colds and headaches.
The right dose of Stelara depends on a child’s weight. Doctors must follow the exact dosage to ensure it’s right for each patient.
Stelara isn’t approved for Crohn’s or ulcerative colitis in kids. But, it has helped teens with psoriasis in the CADMUS study. It also works well for kids with tough psoriasis over time.
“The incidence of psoriasis in children has been reported at 0.72 per 100,000 person-years according to a population-based study.”
Doctors must weigh the pros and cons of Stelara for young patients. They consider the patient’s health and how severe their condition is.
Conclusion
Stelara is a biologic medication that targets autoimmune conditions. It includes ustekinumab, which helps reduce inflammation. This makes it effective for treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Studies have shown Stelara’s success in clinical trials. It improves symptoms and helps patients manage their chronic illnesses. Healthcare providers use it carefully because of possible side effects like infections and cancers.
Stelara is a key treatment for autoimmune diseases. It’s a targeted therapy for those who haven’t responded to other treatments. By reducing symptoms and promoting remission, Stelara improves life quality for those with these diseases.
