Psoriasis Clinical Trial: A Study of Guselkumab Administered Subcutaneously in Bio-naive Participants With Active Psoriatic Arthritis Axial Disease (2023)

FAQs

How effective is guselkumab for psoriasis? ›

Furthermore, a 2-years multicenter study enrolling 264 patients undergoing treatment with guselkumab for moderate-to-severe plaque psoriasis showed a reduction in overall survival rate from 0.989 to 0.674 at week 104.

Tremfya (guselkumab) is a biologic approved for the treatment of psoriasis and psoriatic arthritis.

In two medical studies, more than 5 out of 10 patients treated with TREMFYA® had at least a 20% improvement in active PsA symptoms (joint pain, stiffness, swelling) at 24 weeks compared to placebo. Learn how TREMFYA® can help adults with active psoriatic arthritis.

HORSHAM, PA, July 14, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA^® (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin ...

Elevated liver enzymes were reported more frequently in the TREMFYA group (2.6%) than in the placebo group (1.9%). Of the 21 subjects who were reported to have elevated liver enzymes in the TREMFYA group, all events except one were mild to moderate in severity and none of the events led to discontinuation of TREMFYA.

Biologics don't cure psoriasis, but they're effective. Some people see clearer skin within a few weeks. These drugs may be the best option if your symptoms are moderate to severe. Biologics work better than conventional drugs like methotrexate, acitretin (Soriatane), and cyclosporine (Neoral, Sandimmune).

Alcohol doesn't interact with Tremfya specifically. But alcohol use may affect your plaque psoriasis or psoriatic arthritis. And like Tremfya, it might make it harder for your immune system to fight germs that can cause infections.

between $0 and $10 per month. 1. Actual out-of-pocket costs may vary based on dosing, indication, site of care, insurance coverage, and your eligibility for support programs. Contact your insurance provider for more details on your individual plan.

Tremfya hasn't been linked to weight loss or weight gain in studies. However, weight loss could be a sign of an infection, such as TB, or other condition that requires treatment.

What are the problems with Tremfya? ›

The most common side effects of TREMFYA^® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis.

You may need patience to see the treatment results you want after starting a biologic for psoriatic arthritis. For some people, it can take around three months to see meaningful results. Your doctor will likely have you stay on a biologic for at least six months to give it time to work.

Cimzia, Enbrel, Humira, and Remicade are shown to be safe and effective when taken with methotrexate. Talk to your health care provider about whether using any other treatments with a biologic is right for you.

How long will I need to take guselkumab before it has an effect? Some improvement in your psoriasis may occur in the first few weeks of treatment, but it can take 4 months to see the full benefit. In clinical trials, more than 8 out of 10 patients were clear or nearly clear of their psoriasis by 4 months.

Official answer. The newest systemic treatment for plaque psoriasis is the tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu).

Many psoriasis patients develop liver disease. Here's what we know about how the conditions are related. Up to 47 percent of psoriasis patients develop nonalcoholic fatty liver disease (NAFLD), a potentially life-threatening condition involving fat deposits in the liver not caused by alcohol abuse.

You should not use Tremfya if you are allergic to guselkumab or Polysorbate 80. Tell your doctor if you have ever had tuberculosis, or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled.

Biologics require ongoing treatments.

Psoriasis is a chronic condition that doesn't have a cure, even with biologic treatment.

Results: Secukinumab is the most expensive biologic with a 3-year cost of $182,718 compared with a 3-year cost of $5,000 for phototherapy.

What are the disadvantages of biologics in psoriasis? ›

The main side effects that biologics can cause include infections and malignancies. While reducing inflammation in the skin is good for psoriasis, blocking the immune system — which defends the body from infections and combats cancerous cells — can potentially lead to adverse effects.

Tremfya has an average rating of 7.6 out of 10 from a total of 32 reviews for the treatment of Plaque Psoriasis. 69% of reviewers reported a positive experience, while 22% reported a negative experience.

TREMFYA improved fatigue during the placebo-controlled periods of both studies at week 24, and through one year of active treatment.

Generic Name: guselkumab

It works by blocking a certain natural substance in your body (interleukin-23) that may cause inflammation and swelling. Guselkumab can help lessen the red, scaly, itchy patches of skin caused by plaque psoriasis and lessen the pain and swelling in the joints caused by psoriatic arthritis.

Years of research and testing are needed to ensure that brand-name biologic drugs are safe and effective. This testing can make the drugs expensive. The drugmaker of a brand-name biologic can sell the drug for up to 12 years . After that, other drugmakers can create biosimilar versions.

Due to their large molecular size, biologics are usually administered by injection or infusion. The cost of storing temperature-sensitive medications, providing space for infusions, and necessitating healthcare provider time, has added to the overall price of biologics in the U.S. healthcare system.

Investigators found that individuals who received the every-16-week dosing maintained the disease control, using the absolute Psoriasis Area and Severity Index (PASI) score, at 92.6% compared with those who were on the every-8-week dosing at 91.9%, which met the study's primary endpoint at week 68.

Stelara injection: Just like the spray version of this medicine, the Stelara injection is used to manage various psoriatic conditions in adult patients. The retail price of a supply of 0.5 milliliters of Stelara is around $10,770.

TREMFYA® is given as a 100 mg injection under your skin that you only need to take every 8 weeks, after 2 starter doses at weeks 0 and 4. That's about 2 whole months that you don't have to think about your treatment schedule.

Official answer. The best place to inject Tremfya is into the front of your thighs or the lower part of your abdomen, avoiding the area around your belly button (stay an inch away from your belly button). If somebody else is giving you your injection they can also administer it into the outer area of your upper arm.

How do I know if Tremfya is working? ›

If you're taking Tremfya (guselkumab) for plaque psoriasis, you might start to see clearer skin after about 4 months. On the other hand, if you're taking this medication for psoriatic arthritis, you may start to see improvement in your symptoms (e.g., joint pain, stiffness, swelling) after about 6 months.

TREMFYA can be used with or without a type of medicine called a conventional Disease-Modifying Anti-Rheumatic Drug (DMARD), such as methotrexate. You should not stop using TREMFYA without speaking to your doctor first. If you stop treatment, symptoms of psoriasis may come back.

TREMFYA® is a prescription medicine that may cause serious side effects, including serious allergic reactions and infections. TREMFYA® affects your immune system. It may increase your risk of infections and lower your ability to fight them.

Humira has an average rating of 6.3 out of 10 from a total of 662 ratings on Drugs.com. 54% of reviewers reported a positive effect, while 33% reported a negative effect. Tremfya has an average rating of 6.7 out of 10 from a total of 65 ratings on Drugs.com.

Interactions between your drugs

No interactions were found between prednisone and Tremfya.

Disease-modifying anti-rheumatic drugs (DMARDs)

These medications address the underlying systemic inflammation in psoriatic arthritis. They are critical for slowing and stopping the course of inflammatory disease and can treat both skin and joint pain at the same time.

“Bimekizumab has shown excellent clinical results in psoriasis and psoriatic arthritis, the clinical space where it is likely to be approved and excel in patient outcomes, including PASI-100 responses, and it may also provide substantial benefit to patients with hidradenitis suppurativa”, Bunick said.

Option #1: Acitretin. Acitretin (Soriatane) is an oral retinoid. Retinoids are a form of vitamin A. Acitretin is the only oral retinoid used to treat severe psoriasis in adults.

What is the best anti inflammatory for psoriasis? ›

For both psoriasis and psoriatic arthritis, NSAIDs are a common first-line treatment. Typically available over the counter, NSAIDs include aspirin, ibuprofen (Advil), and naproxen sodium (Aleve). Your doctor may provide a prescription-strength NSAID if appropriate. NSAIDs are anti-inflammatory medications.

Cost and Cost-Effectiveness. Guselkumab is available as a 100 mg/mL pre-filled syringe at a price of $3,060.

Infection was a common side effect of Tremfya in clinical trials. This medication can lower the activity of the immune system, which could make it harder for the body to fight off infections. Symptoms of an infection can include: fever.

At this time, there is no cure for psoriasis – not yet, at least. Still, dermatologists have treatments to help their patients achieve the next best thing: clear or near-clear skin and decreased systemic inflammation.

Cyclosporine suppresses the immune system. Doctors prescribe it to treat severe psoriasis that has not responded to other treatments. Cyclosporine is a pill that a person takes every day.

The FDA also approved tapinarof (VTAMA; Dermavant) cream 1%, a once-daily, steroid-free topical treatment for plaque psoriasis in adults regardless of disease severity, becoming the first FDA-approved steroid-free topical medication.

Guselkumab was effective in controlling both articular and skin manifestations of PsA patients. Absolute PASI significantly decreased from 10.5 to 4.8, 1.9 and 1.3 at weeks 12, 24, and 52, respectively.

If you're taking Tremfya (guselkumab) for plaque psoriasis, you might start to see clearer skin after about 4 months. On the other hand, if you're taking this medication for psoriatic arthritis, you may start to see improvement in your symptoms (e.g., joint pain, stiffness, swelling) after about 6 months.

Ciclosporin. Ciclosporin is a medicine that suppresses your immune system (immunosuppressant). It was originally used to prevent transplant rejection but has proved effective in treating all types of psoriasis. It's usually taken daily.

Taking Tremfya shouldn't cause you to lose your hair. However, psoriasis of the scalp can lead to temporary hair loss. Using other psoriasis treatments (besides Tremfya) or having scalp irritation from scratching can also cause hair loss.

Is TREMFYA worth it? ›

Tremfya has an average rating of 7.6 out of 10 from a total of 32 reviews for the treatment of Plaque Psoriasis. 69% of reviewers reported a positive experience, while 22% reported a negative experience.

The most common side effects of TREMFYA^® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis.

Humira has an average rating of 6.3 out of 10 from a total of 662 ratings on Drugs.com. 54% of reviewers reported a positive effect, while 33% reported a negative effect. Tremfya has an average rating of 6.7 out of 10 from a total of 65 ratings on Drugs.com.

Humira. Humira is generally considered the fastest of the biologic treatments for psoriasis.

Alcohol with Tremfya

There is no known interaction between Tremfya and alcohol. That said,alcohol may increase swelling and inflammation in your body, which can worsen plaque psoriasis or psoriatic arthritis. (Tremfya is used to treat both of these conditions.)

Vitamin D derivatives have been widely used as a treatment for psoriasis in topical form. Vitamin D has been found to be a immune regulator that may benefit inflammatory diseases like psoriasis through its effects on T-lymphocytes type 1 (Th1) cells^{46, 47}.

Vitamins are no replacement for conventional psoriasis treatments, but vitamins A, E, D, and C may help to reduce symptoms and prevent severe flare-ups. Speak to a doctor before supplementing vitamins to manage a medical condition. Vitamin intake is more effective in the diet than in supplement form.