Thursday, September 29, 2022

Is Tremfya Approved For Psoriatic Arthritis

The Voyage Trial Program

Tremfya, How to use it !!!

VOYAGE 1 and 2 assessed similar regimens of subcutaneous guselkumab in patients with moderate to severe psoriasis, yet differed in eligible concomitant treatment criteria patients were not permitted to use methotrexate during the assessment.

The program included 1245 patients randomized to either guselkumab at baseline, week 4 and 12, then once every 8 weeks, or placebo at baseline, week 4 and 12, then crossover to guselkumab at weeks 16 and 20, then once every 8 weeks.

How Long Does It Take To Work

In clinical studies, people with plaque psoriasis saw results after taking three doses of Tremfya over 16 weeks. Researchers looked at adults with moderate to severe plaque psoriasis who took Tremfya or a placebo . After 16 weeks, psoriasis symptoms cleared up entirely or eased in 84% to 85% of people who took Tremfya. This was compared with 7% to 8% of people who took a placebo.

In clinical studies, people with psoriatic arthritis also saw results after just 16 weeks of treatment. For instance, after this period of time, 52% to 55% of people taking Tremfya had a 20% reduction in their psoriatic arthritis symptoms. This was compared with 25% to 34% of people who took a placebo.

Tremfya can interact with several other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions increase the number of side effects or make them more severe.

Drug Forms And Administration

For psoriatic arthritis and plaque psoriasis, both Tremfya and Stelara are given as injections under your skin . With either drug, a healthcare provider will administer your first dose. Then, they can show you or your caregiver how to give the drug at home.

For Tremfya

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.

After your first dose of the drug, youll receive another dose 4 weeks later. Then, youll receive another injection once every 8 weeks.

For Stelara

Stelara also comes as a solution. Its available in single-dose prefilled syringes and single-dose vials.

After your first dose of the drug, youll receive another dose 4 weeks later. Then, youll receive another injection once every 12 weeks.

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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.

Tremfya For Psoriatic Arthritis

TREMFYA Approved by U.S. FDA as the First Selective ...

The Food and Drug Administration approves prescription drugs such as Tremfya to treat certain conditions. In addition to treating psoriatic arthritis, which is discussed below, Tremfya is also approved for treating plaque psoriasis. For more information about this condition, see the Other uses for Tremfya section below.

When you have psoriatic arthritis, your immune system is overactive. It attacks healthy tissues and cells, causing joint pain and inflammation. It also causes your body to make too many skin cells, leading to a buildup of cells and areas called plaques. These plaques are flushed, itchy patches on your skin.

For this condition, Tremfya may be taken alone or in combination with certain other drugs. These other drugs include certain disease-modifying antirheumatic drugs such as methotrexate.

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Tremfya Approved By Fda As The First Selective Interleukin

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration has approved TREMFYA® for adult patients with active psoriatic arthritis , a chronic progressive disease characterized by painful joints and skin inflammation., TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin -23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA.

The safety and efficacy of TREMFYA in PsA have been demonstrated in two pivotal Phase 3 clinical trials. TREMFYA is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. TREMFYA can be used alone or in combination with a conventional Disease Modifying Anti-Rheumatic Drug or DMARD .

The Unmet Needs in PsAPsoriatic arthritis affects about 1.5 million Americans. Studies show that up to 30 percent of the more than eight million Americans living with psoriasis will also develop PsA. There is currently no cure for the disease and, despite available treatments, many people living with PsA are still searching for more options that can help alleviate their symptoms and provide some relief.

Beyond its impact on improving symptoms of PsA in joints, among patients with psoriatic skin involvement, TREMFYA also resulted in an improvement in the skin manifestations of psoriasis in patients with PsA.

The Discover Trial Program

The DISCOVER trials included 1120 patients who had active psoriatic arthritis despite receiving standard therapy. A majority of guselkumab-treated patients were naïve to biologic therapy, and approximately 30% of patients in DISCOVER 1 had previous exposure to either 1 or 2 tumor necrosis factor inhibitor therapies. Concomitant methotrexate, oral corticosteroid, and non-steroidal anti-inflammatory drugs were permitted in the trial program, and used by 57%, 17%, and 64% of patients, respectively.

Investigators randomized patients to 3 treatment arms:

  • Subcutaneous guselkumab 100 mg at baseline, week 4, then every 8 weeks
  • Subcutaneous guselkumab 100 mg every 4 weeks
  • Placebo, then switched to subcutaneous guselkumab 100 mg every 4 weeks at week 24

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New Treatment Approved For Psoriatic Arthritis

We are pleased to share that a new biologic treatment has been approved for the treatment of psoriatic arthritis. People who have this condition can suffer from inflammation in joints of the hands and feet as well as larger joints such as the elbows, shoulders, hips, knees and lower back. There is also inflammation in the tendons and ligaments that attach to these joints. Some people also suffer with a significant amount of psoriasis where others may only have a family history of psoriasis or have limited areas on the scalp and nails. The ideal treatment will reduce inflammation in all areas to reduce pain, stiffness and areas of skin involvement.

Tremfya is a large protein based treatment known as a biologic. It binds to a substance called Interleukin-23 to prevent excess signalling to the immune system. This results in a reduction of inflammation in all areas affected by psoriatic arthritis. It is given by injection by either a pre-filled syringe or a patient-controlled autoinjector called a One-Press. After the initial injection, a second dose is given 4 weeks later and then every 8 weeks as a maintenance dose. Tremfya was initially approved for psoriasis, but it is very exciting to see the proven benefits it has on the joints as well!

Drug Forms And Strengths

New Data on Janssen’s TREMFYA For Psoriatic Arthritis Patients

Tremfya comes as a solution thats given as an injection under your skin . The medication is available in one strength: 100 milligrams/milliliter .

Tremfya comes in 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.

A healthcare provider will give you your first dose of Tremfya. Then they can show you or your caregiver how to give the injections at home.

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Tremfya Already Approved For Psoriasis Inhibits An Immune System Protein Called Il

Psoriatic arthritis may be treated with a wide variety of medications, from NSAIDs that focus on pain relief to disease-modifying drugs and biologics aimed at actually slowing the progression of this inflammatory condition. While many of the biologics used for psoriatic arthritis block an immune system protein called tumor necrosis factor , PsA patients have in recent years gained access to a growing number of drugs that target types of interleukin, another inflammatory protein.

In 2016, the FDA approved secukinumab , which targets IL-17A. In 2017, the agency approved ixekizumab , which also blocks IL-17A.

Now the FDA has approved a different interleukin blocker, but this one targets IL-23 instead.

Already approved for psoriasis, guselkumab is now the first IL-23 inhibitor to be FDA-approved for the treatment of psoriatic arthritis.

Another medication that targets both IL-23 and IL-12, ustekinumab has been approved to treat PsA since 2013.

Tremfya, which is taken via subcutaneous injection, can be used alone or along with a traditional DMARD such as methotrexate. According to Janssen, the drugs manufacturer, FDA approval for psoriatic arthritis was granted after two phase 3 clinical trials demonstrated that patients with active PsA who used it were more likely to have improvements in disease activity compared to those who took a placebo.

Whether or not Tremfya is more effective than other biologics for PsA is unclear.

More Common Side Effects

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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Side Effects And Risks

Tremfya and Stelara are both biologic drugs, which means that theyre made from parts of living organisms by using advanced technology. Therefore, both medications can cause some similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Tremfya, with Stelara, or with both drugs .

  • Can occur with Tremfya:

Serious side effects

These lists contain examples of serious side effects that can occur with Tremfya, with Stelara, or with both drugs .

  • Can occur with Tremfya:
  • few unique serious side effects
  • Can occur with Stelara:
  • risk of certain infections including those of the skin, lungs, bones, and urinary tract
  • a type of skin cancer called nonmelanoma
  • reversible posterior leukoencephalopathy syndrome
  • pneumonia that isnt caused by an infection
  • Can occur with both Tremfya and Stelara:
  • allergic reaction
  • Can Biosimilars Be Used With Other Treatments

    Tremfya approval in U.S. for psoriatic arthritis looks ...

    It is important to tell your health care provider about all treatments, medicines, vitamins or supplements that you are taking.

    Like all biologics, biosimilars can be used with other treatment options including topicals and phototherapy. The biologics Enbrel, Humira and Remicade are shown to be safe and effective when taken with methotrexate. This means that their biosimilars, including Erelzi, Amjevita, and Inflectra, may be safe and effective when taken with methotrexate.

    • With Inflectra being the biosimilar to Remicade, its use in combination with phototherapy may increase the risk for skin cancer.
    • No drugs that interact with biologics should be combined with their respective biosimilars.

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    J& j’s Tremfya Filed For Approval In Us For Psoriatic Arthritis

    Seeking share of increasingly competitive psoriasis market

    Johnson & Johnson has submitted an application to the FDA for the approval of Tremfya in psoriatic arthritis, which could further congest an intensely competitive therapy area.

    Tremfya is Janssens follow-up to IL-23/IL-12 inhibitor blockbuster Stelara , which has faced competition from rival new treatments across immunology indications.

    This includes Novartis Consentyx , AbbVies Skyrizi , Eli Lillys Taltz and Pfizers Xeljanz , which are all already approved in psoriatic arthritis.

    The application to the FDA is based on the top line results from the pivotal phase 3 trials of Tremfya, DISCOVER-1 and DISCOVER-2.

    The drug hit its primary endpoint of ACR20 response at week 24, and multiple secondary endpoints including ACR50/70, resolution of soft tissue inflammation , disease activity , improvement in physical function , skin clearance and quality of life .

    DISCOVER-2 also assessed the effect on structural damage using the van der Heide-Sharp score as a key endpoint. DISCOVER-1 studied Tremfya in 381 participants, including some who were previously treated with anti-TNF biologics, and the duration of the study was 52 weeks. DISCOVER-2 included 739 biologic-naive participants, and continued up to 100 weeks.

    However, J& J has been subject to another head-to-head trial Eli Lillys Taltz outperformed Tremfya in a post-marketing trial in patients plaque psoriasis.

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    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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    Which Vaccines Arent Safe To Get While Im Taking Tremfya

    While you take Tremfya, avoid getting live vaccines. These vaccines contain a weakened form of a virus or bacteria. If your immune system is healthy, live vaccines shouldnt make you sick. But taking Tremfya may weaken your immune system. So your body may not be able to fight the virus or bacteria in the vaccine as your body usually would.

    Examples of live vaccines that you should avoid include:

    However, its safe to get non-live vaccines during your Tremfya treatment. These vaccines dont have any live viruses in them. Examples of inactive vaccines include:

    Before you start to take Tremfya, ask your doctor if you need any vaccines. Its best to get these vaccines before you start your Tremfya treatment or get a non-live form while you take Tremfya.

    Tremfya Generic Or Biosimilar

    Biologics for Psoriatic Arthritis

    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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    Is Tremfya An Immunosuppressant

    Yes, Tremfya is an immunosuppressant. This means that it works by lowering the activity of your immune system.

    Specifically, the drug binds to a certain protein in your body and decreases how active your immune system is. This action helps ease inflammation and reduce the symptoms of your condition.

    If you have more questions about how this drug works, see the How Tremfya works section above.

    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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