What Else Should I Know
The Ustekinumab pen or pre-filled syringe must be refrigerated in its original container. Do not freeze this medicine.
You must continue your regular visits to the rheumatologist. Your doctor will monitor you for any improvements in your disease and for any signs of infections. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including Ustekinumab.
A Federal Drug Administration approved medication guide can be found at:
How Safe And Effective Is Stelara
Stelara has been used to treat psoriasis in the UK since 2009. Real-world safety and effectiveness data is being compiled by the British Association of Dermatologists Biologics Interventions Register . It is recommended that all people taking biologic treatments for their psoriasis should be asked for their data to be included in this register.
What Are The Possible Side Effects Of Stelara
Stelara may cause serious side effects, including:
These are not all of the possible side effects of Stelara. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.You may also report side effects to Janssen Biotech, Inc. at 1-800 JANSSEN .
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What Does Stelara Cost
Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Stelara manufacturers website to see if they have support options.
If you have certain autoimmune conditions, your doctor may prescribe Stelara for you.
Stelara is used for the following long-lasting diseases:
To control symptoms of these long-lasting diseases, your doctor may prescribe medications to slow down the activity of your immune system.
Stelara is an antibody thats made in a lab. It works by blocking substances made by your immune system that can cause long-lasting inflammation. These substances, called cytokines, promote inflammation and may cause disease. By blocking cytokines, Stelara can help control symptoms and relapses of certain diseases.
Find answers to some commonly asked questions about Stelara.
How Is Tremfya Used
Individuals take Tremfya at home by giving themselves an injection under the skin via a pre-filled syringe. Most people will be trained by a nurse to give the injection to themselves. The second dose is taken four weeks after the first, but after that Tremfya is usually taken every eight weeks.
People taking Tremfya will have regular blood tests every three to six months usually carried out by Dermatology Nurses, Rheumatology Nurses or by their own GP to monitor for infections or other possible effects of the treatment. People taking Tremfya are more at risk of infections and so should be vaccinated against pneumonia and have an annual flu vaccination. However, not all vaccinations are safe in people taking Tremfya live vaccinations should be avoided. Check with a doctor or nurse before having any vaccinations or taking other medication if you are not sure. Tremfya can be prescribed on its own, or alongside methotrexate.
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Report A Janssen Product Quality Complaint
You may contact the Medical Information Center by calling 1-800-JANSSEN to speak to a clinical expert regarding your question or to report a product quality complaint.
Report a Janssen COVID-19 Vaccine Product Quality Complaint
Report a Product Quality Complaint to Janssen at 1-800-565-4008 or 1-908-455-9922 .
Does Stelara Have A Black Box Warning
No, Stelara doesnt have a black box warning, which is also called a boxed warning. These warnings are used to alert healthcare professionals and patients about very serious side effects that can happen with some drugs.
Stelara can cause serious side effects. But the Food and Drug Administration hasnt required the manufacturers of Stelara to include a black box warning with this medication.
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Clarity On Guselkumabs Effectiveness In Certain Patients
In previous studies that cemented guselkumab as a treatment option for PsA, what was odd was that the results were pretty comparable,Eric M. Ruderman, MD, professor of medicine and associate chief for clinical affairs in the Division of Rheumatology at Northwestern University in Chicago, Illinois, said in an interview. We didnt really have a sense of how well it worked in patients who had failed other biologics, which is where you might expect a drug with a new mechanism to be used when it comes into a particular disease category.
Dr Eric Ruderman
Not surprisingly, in this study, the overall response rate was a little less than the response rate in the other two trials, said Ruderman, who was not involved in the study. You cant really compare across studies, but it does fit with what we might expect: People whove previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasnt seen a TNF inhibitor.
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Fda Approves Treatment For Psoriatic Arthritis For Pediatric Patients 6 Years And Older
- FDA News Release
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How To Take Them
A person takes either Stelara or Humira over a long period of time.
Individuals receive these medicines by injection. Biologics would not survive in the gut, so people cannot take them as pills.
A healthcare professional will usually give a person an injection pen so that they can inject themselves. The exact dose depends on individual factors, including the severity of the condition.
How Safe And Effective Is Tremfya
Tremfya is a new medication that was licensed to treat psoriasis in the UK in 2017 and psoriatic arthritis in 2020. Real-world safety and effectiveness data is being collected by a long-running study, the British Association of Dermatologists Biologics and Immunomodulators Register . It is recommended that all people taking biologic treatments for their psoriasis should be asked for their information to be included in this register.
A Psoriatic Arthritis Register is run by the British Society for Rheumatology and it is recommended that all people taking biologic treatments for their psoriatic arthritis should be asked for their information to be included in this register.
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In Active Psoriatic Arthritisacr Response Rates Over Time1
ACR20 Results at Week 24
ACR20 RESPONSE IN BIOLOGIC-NAÃVE PATIENTS THROUGH WEEK 241-3*
PSUMMIT I: ACR20 response among biologic-naÃ¯ve patients through Week 241-3*
- In PSUMMIT I, ACR20 response was achieved at Week 24 in 42% and 50% of patients taking STELARAÂ® 45 mg and 90 mg, respectively, vs 23% of patients taking placebo 1-3*
- In PSUMMIT I, concomitant MTX use did not appear to influence the efficacy or safety of STELARAÂ®1
In this intent-to-treat analysis, patients were considered treatment failures if they initiated any protocol-prohibited medications, increased the dose of MTX or oral corticosteroids above baseline, or discontinued study agent due to unsatisfactory therapeutic effect for PsA or an adverse event of worsening PsA or psoriasis. Missing data last-observation-carried-forward rules were applied. The patients who early escaped at Week 16 were considered treatment failures and had Week 16 data carried forward through Week 24.1,3
*Previous exposure to anti-TNF agents was not allowed. Two patients had prior exposure to biologics: 1 to alefacept and 1 to efalizumab.
In this intent-to-treat analysis, early escape rules were not applied. Efficacy evaluations were based on the subjects initial randomized assignment. Subjects who qualified for early escape from the 45-mg group were counted in the 45-mg group. Concomitant medications were required to remain at stable doses through Week 52.3
Consistent ACR20 Response Rates Through Week 100
Tremfya Generic Or Biosimilar
Tremfya contains the active drug guselkumab. Its available only as a brand-name medication. Tremfya isnt currently available in biosimilar form.
A biosimilar is a medication thats similar to a brand-name drug. A generic medication, on the other hand, is an exact copy of a brand-name drug. Biosimilars are based on biologic medications, which are made from parts of living organisms by using advanced technology. Generics are based on regular medications, which are made from chemicals. Biosimilars and generics also usually cost less than brand-name drugs.
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Will Stopping Stelara Treatment Cause Any Side Effects
No, you shouldnt have withdrawal symptoms when you stop Stelara treatment. Withdrawal symptoms are side effects that can happen when you stop taking a drug that your body has become dependent on. These symptoms werent reported in studies of people receiving Stelara.
But its possible for you to have worsening symptoms of your condition when you stop receiving Stelara. For example, if youre using the medication for ulcerative colitis , you may notice an increase in your UC symptoms when you stop treatment.
If you would like to stop Stelara treatment, talk with your doctor first. You should not stop receiving Stelara without first discussing it with your doctor.
Learn more about some of the side effects Stelara may cause.
Questions About Taking Tremfya
You may have questions about taking Tremfya. Below are some commonly asked questions and their answers.
- What if I miss a dose of Tremfya? Take your missed dose as soon as possible. If you get your Tremfya injections from your doctor, call their office right away to reschedule your missed dose. Youll most likely return to your normal dosing schedule after taking your missed dose, but check with your doctor to make sure.
- Will I need to use Tremfya long term? Yes, youll probably take Tremfya long term. Your doctor can recommend whether doing so is right for you.
- Should I take Tremfya with food? You can take Tremfya with or without food.
- How long does Tremfya take to work? Youll probably need a couple of doses of Tremfya before you notice your symptoms improving. Talk with your doctor about what you can expect from the treatment.
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How Is Stelara Administered
Patients take Stelara as an injection into the upper arm, buttock, thigh, or abdomen. Some patients may be able to inject themselves at home if they are trained by a healthcare provider. It is best to inject the medicine into a different area of skin than the previous injection. Stelara should be refrigerated when not in use.
Most patients will receive the second injection 4 weeks after the first one, and then a single dose every 12 weeks after that. It will usually take around 28 weeks for Stelara to have its full effect3. For adolescents, weight-based dosing will be used.
Us Fda Grants Approval For Janssens Stelara To Treat Psoriatic Arthritis
A completely human monoclonal antibody, Stelara hinders cytokines IL-12 and IL-23.
The US Food and Drug Administration has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson s Stelara to treat paediatric patients aged six years and above with active psoriatic arthritis .
The latest approval was based on pharmacokinetic findings and extrapolation of the validated efficacy and current safety profile of Stelara in various Phase III clinical trials carried out in adult and paediatric moderate-to-severe plaque psoriasis patients and adult active PsA patients.
The Phase III PSTELLAR, CADMUS and CADMUS Jr trials enrolled PSO patients while PSUMMIT I and II studies enrolled PsA patients.
Findings showed that PK exposure of Stelara in paediatric PSO patients with active PsA was in line with that of Phase III trials of the therapy in patients without active PsA.
Furthermore, the exposure was consistent with adults having moderate to severe plaque PSO or adult active PsA patients.
A completely human monoclonal antibody, Stelara hinders cytokines interleukin -12 and IL-23.
It is claimed to be the first and only biologic that acts on the cytokines, offering a new treatment option for children aged six years and above with active PsA.
Stelara is given as subcutaneous injection four times a year following a starter regimen of two doses to treat paediatric active PsA patients of this age group.
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Will I Still Need To Use Topical Skin Treatments If I Use Tremfya
You might. Topical skin treatments are medications that you put on your skin. Your doctor may want you to use topical treatments with Tremfya if your plaque psoriasis or psoriatic arthritis skin lesions are severe. Or your doctor may want you to use a topical until Tremfya provides more relief on its own.
Some topical treatments for plaque psoriasis need to be prescribed by a doctor. But others are available without a prescription .
Topical treatments that you get over the counter often include either salicylic acid or coal tar. Salicylic acid can help skin peel to lift psoriasis scales. And coal tar can help slow the growth of skin cells and ease itching.
You can also get mild topical corticosteroid creams over the counter, but higher-strength creams require a prescription. Corticosteroids can help ease inflammation .
If your symptoms are mild, you may only need topical treatment. But if your symptoms are moderate to severe, you may need an injectable medication such as Tremfya with a topical drug. Your doctor will work to create a medication plan thats right for you.
If you have questions about any of your psoriasis medications, talk with your doctor or pharmacist.
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Fda Approves First Treatment For Active Psoriatic Arthritis In Pediatric Patients
The US Food and Drug Administration approved the first and only biologic medicationustekinumab for the treatment of pediatric patients aged 6 years or older with active psoriatic arthritis .
Ustekinumab is a monoclonal antibody that targets both interleukin -12 and IL-23. Following 2 starter doses, the medication is to be administered 4 times per year as a subcutaneous injection.
The FDAs approval comes after using an extrapolation approach in looking at pharmacokinetic data in multiple Phase 3 studies. The researchers in each study examined the efficacy and safety of ustekinumab in adult and pediatric patients with moderate to severe plaque psoriasis, and adult patients with active PsA. With there being limited data on pediatric PsA, researchers opted to use the extrapolation approach when analyzing the previous pharmacokinetic data.
Upon analyzing the data, the researchers found that pharmacokinetic exposure of ustekinumab in pediatric patients with PsO and active PsA was consistent with that of Phase 3 clinical trials of ustekinumab in pediatric patients with plaque PsO without active PsA. Additionally, the data was consistent with adult patients with moderate to severe plaque PsO or adult patients with active PsA. In terms of the efficacy and safety of ustekinumab, the data endpoints were similar in pediatric PsO patients with active PsA.
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What To Ask Your Doctor
Stelara is an effective treatment for certain autoimmune conditions. If youre considering it as a treatment option, its helpful to learn about the side effects it might cause.
If you have questions about your risk of side effects from Stelara, talk with your doctor. Here are a few questions you could ask them:
- Is there a higher risk of side effects with my first Stelara infusion?
- How can I reduce my risk of side effects during treatment?
- What should I do if I become pregnant while Im receiving Stelara?
- If I experience side effects from Stelara, can my dose be changed?
Ustekinumab In Psa: Real
Only one study to date has been published on drug survival and effectiveness ofustekinumab using real-world data.32 PsA patients in this study were retrieved from the BIOlogic aPUlian REgistry, an Italian longitudinal cohort of patients with rheumatic diseases thatreceived biologic treatments. They enrolled 160 PsA patients initiating ustekinumabfrom 2014 to 2016, of which 54 were biologic-naïve and 106 werebiologic-experienced. Among the biologically experienced patients, nearly half thePsA patients experienced two or more anti-TNF agents. The entire cohort and the tworelevant subsets, biologic-naïve and biologic-experienced, all demonstrated astatistically significant reduction in global disease activity as measured by theDAPSA , disability as assessed by the HAQ, andskin scores at 6 months. Not surprisingly, biologic-naïve patients achievedthe best outcomes with respect to clinical effectiveness at 12 months and drug survival at 12 months . Concomitant treatment withmethotrexate did not increase the survivability of ustekinumab. This real-worldstudy mirrors what has been reported in phase III clinical trials. Ustekinumab is aneffective agent for the management of anti-TNF naïve and experienced PsA patients,and the best outcomes are achieved among PsA patients that are biologic-naïve.
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Can Stelara Cause Anxiety Or Changes In Mood
Although mood changes arent a side effect of Stelara, depression was reported as a rare side effect in studies. And while anxiety isnt a direct side effect of Stelara, it can be a symptom of depression.
Other symptoms of depression may include:
- loss of interest in activities that you usually enjoy
If you have any symptoms of depression, anxiety, or other mood changes during treatment with Stelara, talk with your doctor. Theyll check to see whats causing the change and recommend the best way to treat it.