Stelara Data In Psoriatic Arthritis Presented At Eular 2014
- Treatment with ustekinumab significantly slowed progression of structural joint damage over 24 weeks versus placebo, with inhibition maintained through 52 and 100 weeks of continued treatment
- After 100 weeks, a majority of patients receiving ustekinumab had a clinical improvement in their psoriasis severity
- After 52 weeks, up to three-quarters of patients receiving ustekinumab had achieved Psoriatic Arthritis Response Criteria response
- Ustekinumab was well tolerated and rates of serious infections, malignancies and major adverse cardiovascular events were generally low in all patients treated with ustekinumab for two years
Ustekinumab is effective in inhibiting radiographic progression in patients with active psoriatic arthritis: Integrated data analysis of two Phase 3, randomised, placebo-controlled studies was presented by McInnes et al.
Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 2-year results from a Phase 3, multicentre, double-blind, placebo-controlled study was presented by Kavanaugh A, et al.
*The total duration of the trial was 108 weeks, but the vdH-S and PASI scores were assessed at 100 weeks.
Early and sustained modified PsARC response in psoriatic arthritis patients treated with ustekinumab: Results from PSUMMIT 1 and PSUMMIT 2 by McInnes IB, et al.
Things To Know About Biologics
Because they decrease inflammation and immune system response, biologics can increase the risk of infection. Serious infections can be caused by fungi or bacteria and become life-threatening. Do not start taking a biologic if you have an active infection or are currently pregnant/breastfeeding.
Before you start a biologic, your doctor may test you for tuberculosis and hepatitis B. Starting a biologic when you have TB or hepatitis B can lead to severe infection. If you are at high risk for infection on a biologic, you may need to take other drugs alongside it. If you get fevers, chills, muscle aches, or other symptoms of an infection, talk with your doctor right away.
In some cases, biologic drugs may impact a persons blood cell counts or increase the risk of cancer. Your doctor can tell you if your drug has these risks.
Before beginning treatment for PsA, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs, since many biologics can interact with other drugs. Although it is rare, serious allergic reactions can occur with biologics. Tell your doctor about any allergic reactions you have had to drugs in the past. Signs of an allergic reaction include hives, trouble breathing, abdominal pain, and swelling of the face, tongue, or lips.
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Before Taking This Medicine
You should not use Stelara if you are allergic to ustekinumab, or if you have:
active tuberculosis or
if you have received a BCG vaccine within the past 12 months.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
To make sure Stelara is safe for you, tell your doctor if you have:
signs of infection
if you recently received or are scheduled to receive any vaccine.
Some people using Stelara have developed skin cancer . However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
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How To Store Ustekinumab
- Store ustekinumab in the refrigerator, between 2ºC and 8ºC. Do not freeze. Keep the vials in the original carton to protect them from light until the time of use. Do not shake the vials.
- Keep all medicines out of reach of children.
- Do not leave ustekinumab in the car, on windowsills or in the bathroom. Heat and dampness can destroy some medicines.
Ustekinumab Injection May Cause Side Effects Tell Your Doctor If Any Of These Symptoms Are Severe Or Do Not Go Away:
- swelling of the face, eyelids, tongue, or throat
- difficulty breathing
- tightness in the chest or throat
Ustekinumab injection may increase the risk that you will develop cancer. Talk to your doctor about the risks of using this medication.
Ustekinumab injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administrations MedWatch Adverse Event Reporting program online or by phone .
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In Active Psoriatic Arthritisimprovement Seen Across Domains Of Psa
RESULTS AT WEEK 24 AND WEEK 1002-4*
Note: Enthesitis was measured only in patients with enthesitis at baseline. The MASES index was modified for PsA to include 2 additional sites so that a total of 15 enthesitis sites were evaluated. Enthesitis scores range from 0 to 15, with diagnosis if the score is > 0.
Note: Dactylitis was measured only in patients with dactylitis in 1 digit at baseline. Dactylitis was assessed in the 20 digits of the hands and feet on a scale of 0 to 3 for a total of 60 points, with diagnosis if the score was > 0.
*PSUMMIT I was considered an open-label trial after Week 24.3
In this ITT analysis, early escape rules were not applied. Efficacy evaluations were based on the patients initial randomized assignment. Patients 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
At Week 24, all remaining patients in the placebo group who did not qualify for early escape, crossed over to STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter.3
§Patients who did not receive an injection of STELARA® after crossing over to STELARA® 45 mg from the placebo group were excluded from the enthesitis/dactylitis analysis.3
||In patients with 3% body surface area affected by plaque psoriasis at baseline.
Stelara For Other Conditions
In addition to the uses listed above, Stelara may be used off-label for other conditions. Off-label drug use is when a drug thats approved for one use is used for a different one thats not approved. And you may wonder if Stelara is used for certain other conditions.
Stelara for ankylosing spondylitis
Stelara isnt FDA-approved to treat ankylosing spondylitis .
In clinical studies of Stelara, some people with psoriatic arthritis also had AS. In people with both conditions, Stelara decreased AS symptoms by at least half in 29.3% of people after 6 months of treatment. In people taking a placebo , 11.4% of people had the same result.
However, more recent studies didnt find the drug to be effective in treating AS. These studies were stopped early because Stelara was no more effective than a placebo in reducing AS symptoms.
If youre interested in using Stelara to treat AS, talk with your doctor.
Stelara for lupus
Stelara isnt FDA-approved to treat lupus.
In a small clinical study , Stelara was given to people with active systemic lupus erythematosus. After 6 months of treatment, 62% of people taking Stelara had significantly reduced symptoms. Of people taking a placebo , 33% had the same results. Both groups of people received their treatment in combination with standard lupus medications.
However, a more recent study was stopped early because Stelara wasnt more effective than a placebo in reducing lupus symptoms.
Stelara for rheumatoid arthritis
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Stelara For Crohns Disease
Stelara is FDA-approved to treat moderate to severe Crohns disease in adults.
Crohns disease is a type of inflammatory bowel disease. It causes inflammation in your gastrointestinal tract.
With Crohns disease, you may have:
- pain and cramps in your belly
Effectiveness for Crohns disease
One clinical study looked at effectiveness after 8 weeks of treatment. In this study, clinical remission was reached in 14% to 21% more people who took Stelara than in those who took a placebo .
Clinical remission can also be defined based on a scoring system that measures how severe peoples Crohns disease symptoms are. Lower scores show fewer Crohns disease symptoms. If you have a score of less than 150 points, youre considered to be in remission. The highest possible score is 1,100.
In these 8-week studies, between 18% and 26% more people taking Stelara than those taking the placebo had a decreased score of at least 100 points.
Do You Experience One Or More Of The 4 Key Signs Of Psa
- JOINTSwollen or tender joints
- PSORIATIC PLAQUES Raised, red, scaly patches on the skin
- ENTHESITISSwelling at the place where the tendon attaches to the bone
- DACTYLITISSwelling that runs the entire length of fingers or toes, sometimes known as sausage digits
Have joint and skin symptoms? They might be related
If youve received a psoriasis diagnosis and are now experiencing any or all of the other signs on the list, you may have psoriatic arthritis. The sooner youre able to pinpoint your symptoms and share them all with your rheumatologist, the easier it will be to find a treatment.
STELARA® Can Help
STELARA® is a prescription medicine approved to treat adults with active psoriatic arthritis either alone or with methotrexate. Proven to help control the four key signs of PsA, STELARA® needs to be administered four times a year * less than any other PsA treatment of its kind. Ask your doctor or rheumatologist how STELARA® can help.
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Stelara Is A Biologic That Was Approved For The Treatment Of Psoriasis In 2009 And For The Treatment Of Psoriatic Arthritis In 2013
What is Stelara?
Stelara was approved by the FDA in September 2009 for the treatment of moderate-to-severe plaque psoriasis in patients ages 6 years and older. In September 2013 the FDA also approved Stelara to treat adults with active psoriatic arthritis.
Stelara is given by injection under the skin at week 0 and week 4, and then every 12 weeks afterwards.
To learn more, please visit the Stelara website.
Stelara: Uses Taking Side Effects Warnings
We asked Lisa Zaba, M.D., dermatologist at Stanford Health Care, to answer questions from psoriasis patients about the new COVID vaccines and whether theyre safe for people with autoimmune disease 3. Stelara can work fairly quickly. Those who respond to the drug typically do so within six weeks, though some patients need additional time. You can take Stelara as long as it keeps working and the side effects remain relatively minimal. It isnt successful for everyone, however. As with all IBD medications, it varies from person to person What Is Psoriasis? Researchers estimate that about 2-3% of people around the world have psoriasis. About 10-20% of people with this condition also develop psoriatic arthritis, a related disorder that causes joint pain. What Does Psoriasis Look Like? Psoriasis leads to patches on the skin. These most often appear on the knees, elbows, hands, feet, back, face, or scalp Psoriasis in children and adolescents: diagnosis, management and comorbidities. Paediatr Drugs 2015 17:373-84. 4 Bajorek Z, et al. The impact of long term conditions on employment and the wider UK economy. The Work Foundation 2016
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What Are The Possible Side Effects And Risks Of Taking Stelara
Stelara can reduce your immune systemâs ability to fight off infections caused by viruses, fungus, or bacteria. These can be very serious or even life-threatening. Let your healthcare provider know if you develop any symptoms of infection during treatment with Stelara, such as fever, cough, weight loss, or flu-like symptoms4.
Taking Stelara can cause a slight increase in the risk of developing certain types of cancers, such as skin cancer. It can also increase the risk of a very rare condition called reversible posterior leukoencephalopathy syndrome. Healthcare providers will monitor patients for signs of any serious side effects during treatment4.
The side effects that are most frequently reported by patients who take Stelara are:
- runny nose
- skin reactions where the injection is delivered
This is not an exhaustive list of side effects experienced by those taking Stelara.
Dosage For Psoriatic Arthritis
The usual dose of Stelara for adults with psoriatic arthritis is 45 mg for each injection.
Stelara is given as one subcutaneous injection on each of the following days:
- your first dose is given on day 1
- your second dose is given 4 weeks later
- your third dose is given 12 weeks after your second dose
- the rest of your doses are given every 12 weeks
If you have psoriatic arthritis with plaque psoriasis, your doctor may prescribe a higher dosage of Stelara for you.
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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.
Criteria For Initial Approval
Moderate to severe plaque psoriasis
Aetna considers targeted immune modulators adalimumab , brodalumab , certolizumab , etanercept , guselkumab infliximab , ixekizumab , risankizumab-rzaa , secukinumab , tildrakizumab-asmn , or ustekinumab medically necessary for the treatment of moderate-to-severe plaque psoriasis who meet the following:
Active psoriatic arthritis
Aetna considers targeted immune modulators abatacept , adalimumab , certolizumab , etanercept , guselkumab , infliximab , ixekizumab , golimumab , secukinumab , and ustekinumab medically necessary for the treatment of active psoriatic arthritis .
Aetna considers all other indications as experimental and investigational .
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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.
In Active Psoriatic Arthritisacr Response Rates Over Time1
ACR20 Results at Week 24
ACR20 RESPONSE IN BIOLOGIC-NAÏVE PATIENTS THROUGH WEEK 241-3*
PSUMMIT I: ACR20 response among biologic-naïve patients through Week 241-3*
- In PSUMMIT I, ACR20 response was achieved at Week 24 in 42% and 50% of patients taking STELARA® 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 STELARA®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
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What Are The Risks Of Biosimilars
The risks and side effects of biosimilars are the same as those associated with their biologic reference product. Anyone considering taking a biosimilar should talk with their health care provider about the short- and long-term side effects and risks. It is important to weigh the risks against the benefits.
Biologics and biosimilars act on cytokines, which are specific proteins released by the immune system that can cause inflammation. Biologics suppress the function of the overactive immune system. When on a biologic or biosimilar, you may have a higher risk of infection. If you develop any signs of an infection, contact your health care provider right away.
Signs of infection include:
- Damp, sticky feeling or sweating
Does Stelara Decrease My Immune System Function
Yes. Stelara reduces your immune systems ability to fight off infections.
Having an overactive immune system can lead to inflammation, pain, and other health problems.
Stelara helps decrease the activity of your immune system, which helps stop it from attacking your joints and organs. This can improve your symptoms and your quality of life.
However, when your immune system activity is decreased, you have a greater risk of developing serious or rare infections. You may also have a greater risk of reactivation of infections, such as tuberculosis , that youve had in the past. Reduced immune system function caused by Stelara may also increase your risk of certain cancers, including skin cancer.
Talk with your doctor about infections that youve had in the past. Also, you should call your doctor right away if you think you have an infection during Stelara treatment. If you develop an infection while youre using Stelara, your doctor may have you stop using Stelara for a while. Theyll also inform you when its safe for you to restart treatment.
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