Thursday, December 1, 2022

Does Tremfya Treat Psoriatic Arthritis

How Is Tremfya Used

New Data on Janssen’s TREMFYA For Psoriatic Arthritis Patients

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.

What Are The Possible Side Effects Of Tremfya

Every medication has possible side effects. It is important to be aware of the potential side effects when starting a new medication.

The most common side effects of Tremfya include:6

  • Upper respiratory infections
  • Bronchitis

Tremfya may cause serious side effects, including:6

  • Serious allergic reactions. Stop taking Tremfya and seek emergency treatment with any sign of allergic reaction. This may include trouble breathing, feeling faint or dizzy, swelling of your face or lips, chest tightness, rash or itching skin.
  • Infections. Tremfya may lower your bodys ability to fight infection. Monitor for signs of infection in any area of your body. Your doctor will test you for tuberculosis before starting Tremfya.

These are not all the possible side effects of Tremfya. Talk to your doctor about what to expect or if you experience any changes that worry you.

How To Take Tremfya

You should take Tremfya according to your doctor or healthcare providers instructions.

Tremfya comes as a solution inside single-dose prefilled syringes and single-dose One-Press injectors. You may find one form easier to use than the other, so ask your doctor which form is right for you.

The medication is given as an injection just under your skin . A healthcare provider will usually give you your first dose. Then they can show you or your caregiver how to give injections at home. Also, the Tremfya website has instructions and videos to help you learn how to use Tremfya.

Take Tremfya out of the refrigerator to sit at room temperature for at least 30 minutes before each dose. This will help the injection feel more comfortable.

Be sure to look at the medication to make sure its not cloudy or discolored. If it is, dispose of the syringe or injector properly and use a new one.

After your injection, throw away the device and needle in an approved sharps container after use.

Each prefilled syringe or One-Press injector holds only one dose. Dont reuse either of them or try to give yourself more than one dose.

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What To Do In Case Of Overdose

If you think youve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Tremfya from the pharmacy, the pharmacist will add an expiration date to the label on the package. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The of the Food and Drug Administration is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Tremfya And Other Medications

TREMFYA

Below is a list of medications that can interact with Tremfya. This list doesnt contain all drugs that may interact with Tremfya.

Before taking Tremfya, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

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Voyage 1 And Voyage 2 Study Designs

PHASE 3 Multicenter, Double-blind Trials1,2

PATIENT ELIGIBILITY
  • 18 years of age
  • Moderate to severe plaque psoriasis for at least 6 months
  • Candidates for phototherapy and/or systemic treatment
VOYAGE 1 1,2,4
VOYAGE 2 1,3,4

Before Week 48, patients who discontinued study agent because of lack of efficacy or an adverse event of psoriasis worsening, or who started a protocol-prohibited medication including conventional and biologic systemic therapy, phototherapy, and/or topical therapies for psoriasis were considered nonresponders . Other patients with missing data were considered nonresponders for binary endpoints and nonresponder imputation was applied. After Week 48, with the exception of ultrahigh-potency corticosteroids, other topical agents for psoriasis were permitted.

*After Week 48, an open-label treatment period began where patients initially randomized to TREMFYA® or placebo at Week 0 continued to receive TREMFYA® 100 mg q8w at Week 52 through the extension period. Patients initially randomized to Humira® entered a washout period after their final dose of Humira® at Week 47 and initiated TREMFYA® I00 mg at Week 52 and then q8w thereafter.

§PlaceboTREMFYA® responders received placebo q8w beginning at Week 28. Upon loss of 50% Week 28 PASI response, patients were re-treated with TREMFYA®, another dose 4 weeks later, then q8w thereafter. PlaceboTREMFYA® nonresponders at Week 28 continued TREMFYA® q8w.

Results With Tremfya In Adults With Active Psoriatic Arthritis

TREMFYA® CAN HELP REDUCE JOINT PAIN, STIFFNESS, AND SWELLING AT 24 WEEKS

In two medical studies, more than half of patients treated with TREMFYA® had at least a 20% improvement in active PsA symptoms at 24 weeks compared to placebo.

Study participants with at least a 20% improvement in joint symptoms at 24 weeks

FEWER PSORIATIC ARTHRITIS SYMPTOMS MORE OF WHAT YOU USED TO DO

TREMFYA® can help reduce the joint pain, stiffness, and swelling that make everyday tasks harder to do. In two medical studies, patients ability to perform everyday activities was assessed in a questionnaire. At 24 weeks, people taking TREMFYA® showed an overall improvement in their ability to perform daily activities such as:

FATIGUE WAS REDUCED IN SOME PATIENTS

Treatment with TREMFYA® resulted in improvement in fatigue. In two medical studies at 24 weeks, the level of fatigue was assessed using a questionnaire to measure self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. Patients were asked to indicate their level of fatigue in the seven days prior.

Feeling Fatigued?

In addition to joint pain, stiffness, and swelling, some psoriatic arthritis patients feel more than just tired. In fact, in a small study of PsA patients, 73% experienced PsA-related fatigue.*

*Study was performed in Denmark. Fatigue was assessed using a patient-reported questionnaire.

MORE THAN JOINT RELIEF CLEARER SKIN, TOO

Individual results may vary.

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Acr20 Response By Prior Anti

DISCOVER 1: ACR20 RESPONSE RATESNO PRIOR ANTI-TNF EXPOSURE

ACR20 response by prior anti-TNF exposure was not adjusted for multiplicity. Therefore, statistical significance has not been established.

DISCOVER 1: ACR20 RESPONSE RATESPRIOR ANTI-TNF EXPOSURE

ACR20 response by prior anti-TNF exposure was not adjusted for multiplicity. Therefore, statistical significance has not been established.

After Week 24, treatment failure rules were not applied.

References:1. Data on File. Janssen Biotech, Inc. 2. Deodhar A, Helliwell PS, Boehncke WH, et al. Guselkumab in patients with active psoriatic arthritis who were biologic-naïve or had previously received TNF inhibitor treatment : a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 20:1-11.

Who Is Tremfya For

Biologics for Psoriatic Arthritis

Tremfya is for adults with severe psoriasis who have not had a good response from, or cannot take or tolerate other systemic treatments including ciclosporin, methotrexate or PUVA. You will usually need to have tried these treatments before you can be offered Tremfya. If you have tried these treatments but they did not work, Tremfya might be an option for you.

Tremfya can also be prescribed to treat adults with active psoriatic arthritis if other disease modifying anti-rheumatic drugs have not worked successfully, or cause unwanted side effects. The National Institute for Health and Care Excellence has approved Tremfya to be used for people with psoriatic arthritis with 3 or more tender joints and 3 or more swollen joints, who also have moderate to severe psoriasis and have had 2 conventional DMARDs and at least 1 biologic.

Conventional DMARDs include systemic treatments such as methotrexate, sulfasalazine or leflunomide. Biologic treatments include Adalimumab, Etanercept, Infliximab, Simponi , Taltz .

The Scottish Medicines Consortium has approved Tremfya to be used for people with psoriatic arthritis who have previously tried two conventional DMARDs which have not worked successfully or cause unwanted side effects, and have not had any other biologic treatment, OR, people with psoriatic arthritis who have previously tried two conventional DMARDs and one or more anti-TNF biologic ), OR people who cannot take or are intolerant to anti-TNF biologics.

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Already Approved For Psoriasis The Il

Guselkumab , a monoclonal antibody that blocks interleukin-23 , is FDA-approved for psoriasis. Can it also help treat psoriatic arthritis? Results of a new phase 3 trial point to yes.

About 30 percent of people with skin psoriasis also have psoriatic arthritis, a type of inflammatory arthritis that causes symptoms such as joint pain, stiffness, and swelling. In the new study, which was presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting in Atlanta, 381 adults with psoriatic arthritis were randomly assigned to receive 100 mg of guselkumab every four weeks, 100 mg of the drug every eight weeks, or placebo injections.

Some of the patients in the study had never taken a biologic drug others had previously tried a TNF-inhibitor a different kind of biologic but were not currently taking one.

According to the findings, more than 50 percent of patients in either guselkumab group had an improvement in disease activity of at least 20 percent within 24 weeks, compared to about 22 percent of those in the placebo group. Having previously taken a TNF-inhibitor did not seem to have an impact.

In patients with active PsA demonstrated efficacy for joint and skin symptoms, physical function, and quality of life relative to placebo, the authors concluded.

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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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.

Who Should Not Take Tremfya

New Psoriatic Arthritis Treatments 2021
  • People with active infections should not start Tremfya. You will be tested to check for infections before starting treatment.
  • In most cases, pregnant women should not be treated with Tremfya and women should not breastfeed during treatment with Tremfya. Women should not fall pregnant for twelve weeks after treatment has stopped.

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How To Use Tremfya Syringe

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using guselkumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before treatment with this medication, your doctor will test you for tuberculosis . Your doctor should also monitor you for symptoms of TB during and after treatment with this drug. If needed, treatment for tuberculosis or other infections should be given before receiving this medication.

This medication is given by injection under your skin as directed by your doctor. You may receive your first dose in the doctor’s office. After the first dose, another dose is usually given 4 weeks later, followed by doses every 8 weeks. The injection is given in the upper arms, thighs, or abdomen . Follow your doctor’s instructions carefully.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Clarity On Guselkumab’s 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 didn’t 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 can’t really compare across studies, but it does fit with what we might expect: People who’ve previously failed a TNF inhibitor might be a little less likely to respond to guselkumab, compared to someone who hasn’t seen a TNF inhibitor.”

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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.

Questions About Taking Tremfya

Psoriatic Arthritis Diagnosis | Johns Hopkins Medicine

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 Are Biologics Used To Treat Psoriatic Arthritis

Biologics are taken by injection or by IV infusion depending on label. Some injections you may even be able to do at home by yourself or with a family member. Your health care provider will be able to provide you with more information related to your treatment. Biologics are prescribed for individuals with plaque psoriasis and psoriatic arthritis.

How Does Tremfya Compare To Stelara

Tremfya and Stelara are both injections used to treat plaque psoriasis and psoriatic arthritis in adults. Stelara is prescribed for other conditions, too, such as ulcerative colitis and Crohns disease.

However, Tremfya and Stelara contain different active drugs. Tremfya contains the active drug guselkumab. Stelara contains the active drug ustekinumab.

If youd like to know more about these two drugs, talk with your doctor.

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Financial And Insurance Assistance

If you need financial support to pay for Tremfya, or if you need help understanding your insurance coverage, help is available.

Janssen Biotech, Inc., the manufacturer of Tremfya, offers a program called Janssen CarePath. For more information and to find out if youre eligible for support, call 877-227-3728 or view this program overview.

More Common Side Effects

TREMFYA

The more common side effects of Tremfya can include:

Most of these side effects may go away within a few days or a couple of weeks. If theyre more severe or dont go away, talk with your doctor or pharmacist.

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