TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis (2022)

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TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis

TREMFYA® (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis

In two Phase 3 clinical trials, TREMFYA significantly improved signs and symptoms in joints, skin and soft tissue in adults with active psoriatic arthritis

TREMFYA is the first and only biologic approved for the treatment of active psoriatic arthritis to have improvement in fatigue as measured by FACIT-F in the product label

More than 45,000 patients in the U.S. with moderate to severe plaque psoriasis have been treated with TREMFYA since its original approval in 2017

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 inflammation.[1],[2] TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-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 (e.g., methotrexate).

The Unmet Needs in PsA
Psoriatic arthritis affects about 1.5 million Americans.[3] Studies show that up to 30 percent of the more than eight million Americans living with psoriasis will also develop PsA.[4] 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.

Psoriatic arthritis is a chronic, progressive, immune-mediated disease characterized by joint inflammation, enthesitis (inflammation where the bone, tendon and ligament meet), dactylitis (severe inflammation of the digits of the hands and feet), axial disease (pain in the axial skeleton, primarily in the spine, hips and shoulders) and the skin lesions associated with psoriasis.1 The disease commonly appears between the ages of 30 and 50 but can develop at any time.[5] Though the exact cause of PsA is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease. Without early recognition, diagnosis and treatment, the disease can continue to progress.5

“Psoriatic arthritis is a complex multi-faceted disease and, for many patients, additional biologic options are very much needed,” said Philip J. Measei, M.D., DISCOVER-2 Lead Study Investigator, Director of Rheumatology Research at the Swedish Medical Center/Providence St. Joseph Health and Clinical Professor at the University of Washington School of Medicine in Seattle, WA. “The two Phase 3 pivotal trials evaluating the safety and efficacy of TREMFYA, an IL-23 inhibitor, for the treatment of adults with active psoriatic arthritis provided insight into how it can improve joint symptoms. Today’s approval is exciting for both patients and their physicians, as there is now a new approach available to help manage the symptoms of active psoriatic arthritis that patients face day to day.”

(Video) IL-17 Inhibitors

Pivotal Data Supporting the TREMFYA Approval
The approval of TREMFYA was based on results from two pivotal Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of TREMFYA administered by subcutaneous injection in adults with active PsA compared to placebo. The results, recently published in The Lancet, showed that a significant percentage of patients treated with TREMFYA reached the studies’ primary endpoint of ACR20a at 24 weeks, with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.

In addition, treatment with TREMFYA improved patients’ symptoms, which included skin manifestations of psoriasis, physical functioning as measured by the HAQ-DI (Health Assessment Questionnaire Disease Index)b and SF-36 Physical Component Summaryc score, and soft tissue (enthesitis and dactylitis). TREMYFA also resulted in improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).d

“At Janssen, we strive to reimagine what is possible in how immune-mediated diseases like active psoriatic arthritis are understood and treated,” said David M. Lee, M.D., Ph.D., Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. “TREMFYA is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of psoriatic arthritis to have improvement in fatigue as measured by FACIT-F included in the U.S. Prescribing Information. Today’s approval marks an exciting milestone as we follow the science and search for solutions for patients with these complicated diseases.”

Click to Tweet: #BREAKING: The @US_FDA approves TREMFYA® (guselkumab) for new indication. Read more: https://bit.ly/3gWQ46c

The overall safety profile observed in patients with PsA treated with TREMFYA is generally consistent with the safety profile in patients with plaque psoriasis with the addition of bronchitis and neutrophil count decreased.

About the DISCOVER Development Program
DISCOVER-1 and DISCOVER-2 were Phase 3 randomized, double-blind, placebo-controlled studies that evaluated the safety and efficacy of TREMFYA in 1,120 adult patients with active PsA who had inadequate response to standard therapies. In DISCOVER-1, approximately 31 percent of patients had been previously treated with up to two anti-tumor necrosis factor alpha (anti-TNFα) agents whereas in DISCOVER-2 all patients were naïve to biologic therapy. Approximately 58 percent of patients from both studies had concomitant methotrexate (MTX) use.

The DISCOVER-1 study showed that in patients who received TREMFYA 100 mg every 8 weeks after two starter doses, 52 percent achieved an ACR20 response versus 22 percent treated with placebo (p <0.0001), with a comparable response irrespective of prior TNF exposure. In DISCOVER-2, 64 percent of patients who received TREMFYA every 8 weeks achieved an ACR20 response, versus 33 percent treated with placebo (p <0.0001).

TREMFYA was also shown to relieve patients’ pain in their soft tissue and inflammation in their fingers and toes. In a pooled analysis of DISCOVER-1 and -2 at week 24, treatment with TREMFYA every 8 weeks resolved enthesitis in 50 percent of patients, versus 29 percent in patients receiving placebo (p=0.0301). In another pooled analysis at week 24, treatment with TREMFYA every 8 weeks also resolved dactylitis in 59 percent of patients, versus 42 percent receiving placebo (p=0.0301).

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.

“Finding the right psoriatic arthritis treatment can be hard. Individuals living with this complex disease are often left searching for answers, so it’s important for patients to understand their options and to work closely with their doctor on a treatment plan,” said Stacie Bell, Ph.D., Chief Scientific and Medical Officer, National Psoriasis Foundation. “Approval of new treatments for psoriatic arthritis is welcome news for this community and offers physicians and patients more options in their fight to manage this chronic disease.”

Administration and Access for TREMFYA
Patients may self-inject with the TREMFYA One-Press injector after physician approval and proper training. The TREMFYA One-Press is a single-dose, patient-controlled injector that has received the Arthritis Foundation’s Ease of Use Commendation after being tested in patients with PsA.

Janssen will work closely with payers, providers and pharmacy benefit managers in an effort to help ensure TREMFYA is broadly accessible and affordable for patients living with PsA.

Janssen CarePath offers a comprehensive support program that helps patients get started on TREMFYA and stay on track. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible. TREMFYA BiocoordiNATION offers resources to bio-coordinators within rheumatology and dermatology practices who help patients navigate the healthcare system so that they can start and stay on their prescribed therapy.

About TREMFYA® (guselkumab)

(Video) Psoriatic Arthritis: Overcoming Barriers to Improve Patient Outcomes

Developed by Janssen, TREMFYA® is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin (IL)-23 and inhibits its interaction with the IL-23 receptor. It is approved 1) in the U.S., Canada, European Union, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light) and 2) in the U.S., Japan and Brazil for the treatment of adult patients with active psoriatic arthritis. IL-23 is an important driver of the pathogenesis of inflammatory diseases such as psoriasis and psoriatic arthritis.1

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA.

WHAT IS TREMFYA® (guselkumab)?
TREMFYA® is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).

TREMFYA® is a prescription medicine used to treat adults with active psoriatic arthritis.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TREMFYA®?

TREMFYA® is a prescription medicine that may cause serious side effects,

including:

  • Serious Allergic Reactions. Stop using TREMFYA® and get emergencymedical help right away if you develop any of the following symptoms of a serious allergic reaction:
    • fainting, dizziness, feeling lightheaded (low blood pressure)

    • swelling of your face, eyelids, lips, mouth, tongue or throat

    • trouble breathing or throat tightness

    • chest tightness

    • skin rash, hives

    • itching
  • Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

(Video) Research Update: The Latest News About Psoriasis and Psoriatic Arthritis

Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.

Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed in the section “What is the most important information I should know about TREMFYA®?”
  • have an infection that does not go away or that keeps coming back.
  • have TB or have been in close contact with someone with TB.
  • have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®.
  • are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of TREMFYA®?

TREMFYA® may cause serious side effects. See “What is the most important information I should know about 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.

(Video) Understanding Psoriatic Arthritis: Signs Symptoms Treatments

These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.

Use TREMFYA® exactly as your healthcare provider tells you to use it.

Please read the full Prescribing Information, including Medication Guide for TREMFYA®, and discuss any questions that you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

iDr. Philip J. Mease is a paid consultant for Janssen. He has not been compensated for any media work.

a. ACR20 Response: defined as both improvement of 20 percent in the number of tender and number of swollen joints, and a 20 percent improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure, visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).

b. Health Assessment Questionnaire Disease Index (HAQ-DI): includes 8 categories, reviewing a total of 20 specific functions to evaluate patient difficulty with activities of daily living over the past week. Categories include dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and errands and chores.

c. SF-36 Physical Component Summary: 8 multi-item scales assessing physical function, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and emotional well-being.

d. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale: measured on a 4-point Likert scale (4 = not at all fatigued to 0 = very much fatigued).

[1] Belasco J, Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther 2019;6:305-315.
[2] McLaughlin M, Ostor A. Early Treatment of Psoriatic Arthritis Improves Prognosis. Practitioner 2014;258:4-21.
[3] Johns Hopkins. Psoriatic Arthritis. Available at: https://www.hopkinsarthritis.org/arthritis-info/psoriatic-arthritis/#:~:text=What%20is%20Psoriatic%20Arthritis%3F,may%20also%20affect%20the%20spine. Accessed July 2020.
[4] National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed July 2020.
[5] National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis#:~:text=PsA%20can%20start%20at%20any,psoriatic%20arthritis%20without%20having%20psoriasis. Accessed July 2020.

(Video) Dr. Hong's JAM Module: Psoriasis Pharmacology

FAQs

Is guselkumab approved for psoriatic arthritis? ›

Tremfya (guselkumab) is a biologic approved for the treatment of psoriasis and psoriatic arthritis. Tremfya was approved by the FDA in 2017 for adult patients with active psoriatic arthritis.

Is TREMFYA approved for psoriatic arthritis? ›

TREMFYA is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of psoriatic arthritis to have improvement in fatigue as measured by FACIT-F included in the U.S. Prescribing Information ...

How effective is TREMFYA for psoriatic arthritis? ›

Psoriatic arthritis patients experience joint pain, stiffness, and swelling. In two medical studies, more than half of patients treated with TREMFYA® had at least a 20% improvement in active PsA symptoms (joint pain, stiffness, and swelling) at 24 weeks compared to placebo. Some patients also experienced less fatigue.

What is psoriatic arthritis caused by? ›

Psoriatic arthritis occurs when your body's immune system attacks healthy cells and tissue. The immune response causes inflammation in your joints as well as overproduction of skin cells. It seems likely that both genetic and environmental factors play a role in this immune system response.

What is the best biologic for psoriatic arthritis? ›

New psoriatic arthritis treatment guidelines from the American College of Rheumatology say that most people with active psoriatic arthritis (PsA) should choose an anti-TNF drug, such as adalimumab (Humira) or infliximab (Remicade), as their first line of therapy.

Can I drink alcohol on TREMFYA? ›

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.

What does TREMFYA cost? ›

Table 4CDR Cost Comparison Table for the Treatment of Plaque Psoriasis
Drug / ComparatorStrengthPrice ($)
Guselkumab (Tremfya)100 mg/mL$3,059.7400a
Other Biologics
Adalimumab (Humira)40 mg/0.8 mL$769.9700
Etanercept (Enbrel)50 mg/mL 25 mg/vial$405.9850 $202.9300
11 more rows

How long can you take TREMFYA? ›

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.

How long does it take for TREMFYA to work on arthritis? ›

It takes about 16 weeks for Tremfya to start working in most people, which is two doses of Tremfya because each dose is given 8 weeks apart.

How long does it take for TREMFYA to work on psoriatic arthritis? ›

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.

What are the side effects of 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. These are not all the possible side effects of TREMFYA®.

Is guselkumab a biologic? ›

Guselkumab is a biological treatment indicated for moderate-to-severe psoriasis.

What is guselkumab made from? ›

Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. Solution for injection (injection) The solution is clear and colourless to light yellow.

Is guselkumab an immunosuppressant? ›

Guselkumab has immunosuppressive activity but has not been linked to instances of reactivation of hepatitis B or worsening of hepatitis C.

What are the warning signs of psoriatic arthritis? ›

10 Early Symptoms of Psoriatic Arthritis
  • Sausage fingers. People with PsA often have painful swelling in the fingers and toes. ...
  • Nail changes. ...
  • Scaly patches on elbows and knees. ...
  • Eye pain and redness. ...
  • Joint pain and stiffness. ...
  • Fatigue. ...
  • Stomach issues. ...
  • Tenderness.
Oct 15, 2021

What is the new drug for psoriatic arthritis? ›

Guselkumab (Tremfya) is the newest biologic drug approved to treat PsA. It's the first biologic to target the immune system protein IL-23. Another IL-23 drug called risankizumab (Skyrizi) is already approved to treat psoriasis and PsA. About a dozen biologics are FDA-approved for psoriatic arthritis.

Is psoriatic arthritis a disability? ›

Psoriatic arthritis falls under the classification of immune system impairments of the Disability Evaluation Under Social Security. 2 More specifically, it is listed under section 14.09 titled “Inflammatory Arthritis.” If someone meets the requirements under section 14.09, they may be approved for disability payments.

What is the safest drug to take for psoriatic arthritis? ›

What Is the Safest Drug for Psoriatic Arthritis?
  • Over-the-counter (OTC) Ibuprofen (Advil, Motrin) Naproxen (Aleve) Aspirin.
  • Prescription. Celecoxib (Celebrex)
Jul 21, 2021

What is the safest biologic for psoriasis? ›

Using Biologics with Other Psoriasis Treatments

Cimzia, Enbrel, Humira and Remicade are shown to be safe and effective when taken with methotrexate.

What is the cheapest biologic for psoriatic arthritis? ›

A new study shows that brodalumab is the least expensive biologic option with high efficacy for moderate-to-severe plaque psoriasis in the United States.

How does Covid affect psoriasis? ›

COVID-19 has been thought to worsen chronic inflammatory conditions by driving a negative impact of quarantine on the daily activities of patients, aggravating comorbidities such as obesity, hypertension, and diabetes, which are well-known to be associated with psoriasis.

Does sunlight worsen psoriasis? ›

The right amount of sun

A weekend at the beach is unlikely to clear up psoriasis, because you need long-term exposure. Too much sun, however, can cause a sunburn and result in injury and aggravation of psoriasis. Increase your sun exposure levels slowly.

Is red wine good for psoriasis? ›

There is no evidence that any type of alcohol is better for people with psoriasis. Alcohol consumption affects individuals differently. Factors such as body mass, weight, gender, eating habits, and drinking habits will influence how alcohol affects the body.

Does Tremfya cause hair loss? ›

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.

Can I get Tremfya for free? ›

Johnson & Johnson Patient Assistance Foundation, Inc.

JJPAF gives eligible patients free prescription medicines donated by Johnson & Johnson companies. You may be eligible if you don't have insurance, if your medicine is not covered by insurance, or if you have Medicare coverage and can't pay for your medicine.

What tier drug is Tremfya? ›

Medicare prescription drug plans typically list Tremfya on Tier 5 of their formulary. Generally, the higher the tier, the more you have to pay for the medication.

Where is the best place to inject Tremfya? ›

by Drugs.com

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.

Does Tremfya weaken immune system? ›

Tremfya can weaken (suppress) your immune system, and you may get an infection more easily.

Which is better Humira or Tremfya? ›

TREMFYA®—Consistent PASI 90 Response Rates That Were Superior to Humira® at Weeks 16, 24, and 48. *P<0.001 vs Humira®.

How long does guselkumab take to work? ›

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.

Can you take Tremfya every 4 weeks? ›

For Tremfya, this is one 100-mg injection every 8 weeks. Below is a Tremfya dosing chart for treating plaque psoriasis.
...
Dosage for moderate to severe plaque psoriasis.
DoseWeek
100 mgweek 4
100 mgevery 8 weeks
1 more row
Jun 3, 2021

How soon do you see results with Tremfya? ›

In a clinical study, nearly 9 out of 10 people who saw 90% clearer skin at 28 weeks continued to see 90% clearer skin at 48 weeks. In a study, nearly 7 out of 10 patients with 90% clearer skin at 16 weeks were still clearer at 5 years.

Does Tremfya affect the liver? ›

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.

What is Tremfya made from? ›

Tremfya comes as a solution inside prefilled syringes or devices called One-Press injectors. You'll take the drug as an injection under your skin. Tremfya contains the drug guselkumab, which is a biologic medication. A biologic is made from parts of living cells.

Can Tremfya cause lymphoma? ›

Most clinical trials investigating Tremfya excluded people from participating in the trial if they had current cancer or a previous history of cancer. There is also evidence to show that people with psoriasis have an inherent increased risk of developing several different malignancies including NMSC and lymphoma.

What are the best drugs for psoriatic arthritis? ›

Conventional DMARDs .

These drugs can slow the progression of psoriatic arthritis and save joints and other tissues from permanent damage. The most commonly used DMARD is methotrexate (Trexall, Otrexup, others). Others include leflunomide (Arava) and sulfasalazine (Azulfidine).

How long does it take for TREMFYA to work on psoriatic arthritis? ›

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.

What is the new drug for psoriatic arthritis? ›

Guselkumab (Tremfya) is the newest biologic drug approved to treat PsA. It's the first biologic to target the immune system protein IL-23. Another IL-23 drug called risankizumab (Skyrizi) is already approved to treat psoriasis and PsA. About a dozen biologics are FDA-approved for psoriatic arthritis.

Which is better Taltz or TREMFYA? ›

Patients treated with Taltz demonstrated statistically significantly higher improvements than those treated with TREMFYA as measured by PASI 100 at Week 12 (41.3 percent versus 24.9 percent, P<0.001). Additionally, all major secondary endpoints up to Week 12 were achieved (P<0.001).

What is the safest medicine to take for psoriatic arthritis? ›

What Is the Safest Drug for Psoriatic Arthritis?
  • Over-the-counter (OTC) Ibuprofen (Advil, Motrin) Naproxen (Aleve) Aspirin.
  • Prescription. Celecoxib (Celebrex)
Jul 21, 2021

What are the side effects of 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. These are not all the possible side effects of TREMFYA®.

What are the 5 types of psoriatic arthritis? ›

Psoriatic arthritis is categorized into five types: distal interphalangeal predominant, asymmetric oligoarticular, symmetric polyarthritis, spondylitis, and arthritis mutilans. The distal interphalangeal predominant type affects mainly the ends of the fingers and toes.

Is TREMFYA better than Humira? ›

TREMFYA®—Consistent PASI 90 Response Rates That Were Superior to Humira® at Weeks 16, 24, and 48. *P<0.001 vs Humira®.

Does TREMFYA affect the liver? ›

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.

What is TREMFYA made from? ›

Tremfya comes as a solution inside prefilled syringes or devices called One-Press injectors. You'll take the drug as an injection under your skin. Tremfya contains the drug guselkumab, which is a biologic medication. A biologic is made from parts of living cells.

Is there a cure for psoriasis 2021? ›

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.

What is the best biologic for psoriatic arthritis and psoriasis? ›

These cells and proteins all play a major role in developing psoriasis and psoriatic arthritis (PsA). Biologics such as Enbrel, Humira and Remicade are also considered disease-modifying antirheumatic drugs (DMARDs), which means they attempt to slow or stop the processes in the body that cause joint damage.

What are the warning signs of psoriatic arthritis? ›

10 Early Symptoms of Psoriatic Arthritis
  • Sausage fingers. People with PsA often have painful swelling in the fingers and toes. ...
  • Nail changes. ...
  • Scaly patches on elbows and knees. ...
  • Eye pain and redness. ...
  • Joint pain and stiffness. ...
  • Fatigue. ...
  • Stomach issues. ...
  • Tenderness.
Oct 15, 2021

What is the difference between Tremfya and Cosentyx? ›

While the two drugs are both approved to treat plaque psoriasis, they target different interleukins, which are proteins that regulate immune response. Cosentyx is an IL-17 inhibitor while Tremfya targets IL-23.

Are Taltz and Tremfya the same? ›

Taltz knocks down Tremfya in head-to-head trial in psoriasis patients. Patients treated with Taltz demonstrated statistically significantly higher improvements than those treated with Tremfya as measured by PASI 100 at Week 12.

Is Tremfya better than Stelara? ›

Patients receiving TREMFYA had a significantly greater number of visits from week 28 to week 40 with an Investigator's Global Assessment (IGA) score of 0 or 1 and ≥2-grade improvement from week 16 vs patients receiving STELARA (P<0.001).

HORSHAM, Pa., July 14, 2020 /PRNewswire/ — The Janssen Pharmaceutical Inc. 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 inflammation.. Pivotal Data Supporting the TREMFYA Approval The approval of TREMFYA was based on results from two pivotal Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of TREMFYA administered by subcutaneous injection in adults with active PsA compared to placebo.. The results, recently published in The Lancet , showed that a significant percentage of patients treated with TREMFYA reached the studies’ primary endpoint of ACR20 a at 24 weeks, with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.. “TREMFYA is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of psoriatic arthritis to have improvement in fatigue as measured by FACIT-F included in the U.S. Prescribing Information.. 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.. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA ® and may treat you for TB before you begin treatment with TREMFYA ® if you have a history of TB or have active TB.

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 inflammation.. Today’s approval is exciting for both patients and their physicians, as there is now a new approach available to help manage the symptoms of active psoriatic arthritis that patients face day to day.”. Pivotal Data Supporting the Tremfya Approval The approval of Tremfya was based on results from two pivotal Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of Tremfya administered by subcutaneous injection in adults with active PsA compared to placebo.. The results, recently published in The Lancet, showed that a significant percentage of patients treated with Tremfya reached the studies’ primary endpoint of ACR20a at 24 weeks, with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.. In addition, treatment with Tremfya improved patients’ symptoms, which included skin manifestations of psoriasis, physical functioning as measured by the HAQ-DI (Health Assessment Questionnaire Disease Index)b and SF-36 Physical Component Summaryc score, and soft tissue (enthesitis and dactylitis).. “Tremfya is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of psoriatic arthritis to have improvement in fatigue as measured by FACIT-F included in the U.S. Prescribing Information.. In a pooled analysis of DISCOVER-1 and -2 at week 24, treatment with Tremfya every 8 weeks resolved enthesitis in 50 percent of patients, versus 29 percent in patients receiving placebo (p=0.0301).. 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.. It is approved 1) in the U.S., Canada, European Union, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light) and 2) in the U.S., Japan and Brazil for the treatment of adult patients with active psoriatic arthritis.. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

(guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.. "TREMFYA is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of psoriatic arthritis to have improvement in fatigue as measured by FACIT-F included in the U.S. Prescribing Information.. 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.. (guselkumab) Developed by Janssen, TREMFYA ?. ?is a prescription medicine used to treat adults with active psoriatic arthritis.. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA ?. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Injectable Administration. Only an individual trained in subcutaneous drug delivery should administer the injection.. Use of the pre-filled syringe:Rotate injection sites with each injection.Each single-use prefilled syringe contains 100 mg/mL of guselkumab.Choose an injection site.. After the cap is off, the pre-filled syringe should be used within 5 minutes.Use your hand to pinch the skin at the injection site.. Fungal infection, infection, viral infection. Guselkumab therapy may increase the risk of infection.. Do not initiate guselkumab therapy in patients with any clinically significant active infection until the infection resolves or is adequately treated.. Consider completing all age appropriate immunizations before initiating treatment with guselkumab.. [62791] There are no data on the presence of guselkumab in human milk, the effects on the breast-fed infant, or the effects on milk production.. Guselkumab is administered subcutaneously.. The administration of guselkumab may, in theory, normalize the formation of CYP450 enzymes, resulting in drug interactions.

HORSHAM, Pa., July 14, 2020 /PRNewswire/ -- 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 inflammation.. "TREMFYA is the first and only selective IL-23 inhibitor approved for both active psoriatic arthritis and moderate to severe plaque psoriasis, as well as the only biologic approved for the treatment of psoriatic arthritis to have improvement in fatigue as measured by FACIT-F included in the U.S. Prescribing Information.. In a pooled analysis of DISCOVER-1 and -2 at week 24, treatment with TREMFYA every 8 weeks resolved enthesitis in 50 percent of patients, versus 29 percent in patients receiving placebo (p=0.0301).. TREMFYA ® is a prescription medicine used to treat adults with active psoriatic arthritis.. What is the most important information I should know about TREMFYA ® ?TREMFYA ® is a prescription medicine that may cause serious side effects,including:. 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.. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past.. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A.

HORSHAM, Pa., Sept. 16, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA ® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).. The safety profile observed for TREMFYA in the DISCOVER studies was generally consistent with previous studies as well as the current TREMFYA prescribing information.. "We're excited about the DISCOVER data and the potential of TREMFYA as a treatment option given the unmet needs of patients living with psoriatic arthritis, a chronic lifelong disease," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC.. About TREMFYA ® (guselkumab) Developed by Janssen, TREMFYA ® is a human monoclonal antibody against the p19 subunit of interleukin (IL)-23, and is approved in the U.S., Canada, the European Union, Japan and a number of other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet [UV] light).. The TREMFYA development program includes: two Phase 3 programs evaluating TREMFYA in the treatment of active psoriatic arthritis, a Phase 2b/3 program in Crohn's disease, a Phase 2b/3 program in Ulcerative Colitis, and two Phase 2 programs – one exploring biologic combination therapy in Ulcerative Colitis and the other for the treatment of Hidradenitis Suppurativa.. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA.. Important Safety Information What is the most important information I should know about TREMFYA ® ?TREMFYA ® may cause serious side effects, including infections.. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA ® and may treat you for TB before you begin treatment with TREMFYA ® if you have a history of TB or have active TB.. What are the possible side effects of TREMFYA ® ?TREMFYA ® may cause serious side effects.. 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 and herpes simplex infections.. Janssen Research & Development, LLC and Janssen Scientific Affairs, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

HORSHAM, Pa., Sept. 16, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA ® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).. The DISCOVER program comprises the first-ever Phase 3 studies evaluating a human monoclonal antibody against the p19 subunit of IL-23 for active PsA, and the results have been submitted for presentation at an upcoming medical meeting.. "We're excited about the DISCOVER data and the potential of TREMFYA as a treatment option given the unmet needs of patients living with psoriatic arthritis, a chronic lifelong disease," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC.. DISCOVER-2 included 739 biologic-naïve participants and is planned to continue through 100 weeks.. Janssen also expects to submit a marketing application to the European Medicines Agency seeking approval of TREMFYA as a treatment for PsA before the end of the year.. Important Safety Information What is the most important information I should know about TREMFYA ® ?TREMFYA ® may cause serious side effects, including infections.. 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 and herpes simplex infections.. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A.. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

BEERSE, Belgium--( BUSINESS WIRE )--The Janssen Pharmaceutical Companies of Johnson & Johnson today announced 24-week Phase 3 data showing a significantly greater proportion of patients with active psoriatic arthritis (PsA) treated with TREMFYA ® ▼ (guselkumab) achieved at least a 20 percent improvement in disease signs and symptoms (American College of Rheumatology ACR20 response) compared to placebo.. 1,2 These findings represent the primary endpoints of the DISCOVER-1 and DISCOVER-2 Phase 3 studies, which were designed to evaluate the efficacy and safety of investigational use of guselkumab for the treatment of adult patients with active PsA.. DISCOVER-1 is a randomised, double-blind, multicentre Phase 3 study evaluating the efficacy and safety of guselkumab administered by subcutaneous injection in participants with active psoriatic arthritis including those previously treated with biologic anti-TNF alpha agent(s).. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis.. 5 Deodhar A, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study.. Psoriatic Arthritis.. About Psoriatic Arthritis.

TORONTO, Sept. 10, 2020 /CNW/ - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that Health Canada has approved TREMFYA ® (guselkumab injection) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation.. TREMFYA ® is also approved for the treatment of adult patients with moderate-to-severe plaque psoriasis.. "This new approval represents an important advancement for patients and physicians navigating treatment options for psoriatic arthritis," said Dr. Ron Vender**, Associate Clinical Professor of Medicine at McMaster University, and Director of Dermatrials Research Inc. "TREMFYA ® is already a well-established and proven treatment for patients with psoriasis of the skin, and the data show it can now benefit patients with psoriatic arthritis, providing evidence of significant improvement in joint symptoms.". This approval for TREMFYA ® is based on results from two pivotal Phase 3 clinical trials; DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of TREMFYA ® , administered by subcutaneous injection in adults with active PsA compared to a placebo.. The results, recently published in The Lancet , demonstrated that patients treated with TREMFYA ® reached the primary endpoint of ACR20 response at 24 weeks in both studies (an improvement of at least 20 percent in the number of tender and swollen joints, and at least 20 percent improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure, visual analog pain scale, and C-reactive protein).. "Guselkumab reinforces our broad commitment to developing first-in-class treatments for patients living with psoriatic arthritis and other immune-mediated diseases.". Approximately 58 percent of patients from both studies had concomitant methotrexate (MTX) use.. 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.. It is also approved in Canada, the U.S., Japan and Brazil for the treatment of adult patients with active psoriatic arthritis.. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we're creating a future where disease is a thing of the past.. Janssen Inc. and Janssen Research & Development, LLC are members of the Janssen Pharmaceutical Companies of Johnson & Johnson.. Janssen Inc. September 4, 2020 3 Arthritis Society, Psoriatic Arthritis.. Available at: https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis 4 Arthritis Society, Psoriatic Arthritis.. Available at: https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis 5 Arthritis Society, Psoriatic Arthritis.

Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA and may treat you for TB before you begin treatment with TREMFYA if you have a history of TB or have active TB.. See the detailed “Instructions for Use” that comes with TREMFYA for information on how to prepare and inject a dose of TREMFYA, and how to properly throw away (dispose of) used TREMFYA prefilled syringes or One- Press injectors.. If you inject more TREMFYA than prescribed, call your healthcare provider right away.. If your healthcare provider decides that you or a caregiver may be able to give your injections of TREMFYA at home, you should receive training on the right way to prepare and inject TREMFYA using the prefilled syringe before attempting to inject.. Do not try to inject yourself until you have been shown the right way to give the injections by your healthcare provider.. The TREMFYA prefilled syringe is intended for injection under the skin, not into the muscle or vein.. 1 TREMFYA prefilled syringe. Not provided in the TREMFYA prefilled syringe carton:. Remove your TREMFYA prefilled syringe carton from the refrigerator.. Inject TREMFYA using prefilled syringe. Inject TREMFYA within 5 minutes of removing the needle cover.. Inject TREMFYA using prefilled syringe the skin and not into the muscle.. Dispose of your prefilled syringe Put your used TREMFYA prefilled syringe in an FDA-cleared sharps disposal container right away after use.. If your healthcare provider decides that you or a caregiver may be able to give your injections of TREMFYA at home, you should receive training on the right way to prepare and inject TREMFYA using the One-Press injector.. Inject TREMFYA using the One-Press injector

28.07.22 22:03 DGAP-News: MorphoSys AG MorphoSys AG: Einladung zu MorphoSys' Telefonkonferenz am 4 .. 28.07.22 21:28 DGAP-News: Ekosem-Agrar AG Ekosem-Agrar AG: Vorstandsmitglied Wolfgang Bläsi scheidet zum[...]. 28.07.22 21:25 DGAP-Ad-hoc: Ekosem-Agrar AG Ekosem-Agrar AG: Wolfgang Bläsi scheidet zum Jahreswechsel aus[...]. 28.07.22 19:07 DGAP-News: HELLA GmbH & Co. KGaA HELLA GmbH & Co. KGaA: Ausstieg aus Joint Venture: HELLA einig[...] -0.29%. 28.07.22 19:06 DGAP-Ad-hoc: HELLA GmbH & Co. KGaA HELLA GmbH & Co. KGaA: HELLA einigt sich mit Plastic Omnium üb[...] -0.29%. 28.07.22 18:38 DGAP-Stimmrechtsanteile: HUGO BOSS AG HUGO BOSS AG: Veröffentlichung gemäß § 40 Abs.. 28.07.22 18:35 DGAP-Stimmrechtsanteile: HUGO BOSS AG HUGO BOSS AG: Release according to Article 40, Section 1 of th[...] 0.6%. 28.07.22 17:29 DGAP-Ad-hoc: aap Implantate AG aap Implantate AG: Q2 schwächer als erwartet und Anpassung der[...] 7.52%. 28.07.22. DGAP-Berichte: Alzchem Group AG Halbjahresfinanzbericht 2022 1.07%. 28.07.22. DGAP-Berichte: Drägerwerk AG & Co. KGaA Halbjahresfinanzbericht 2022 1.6%. Die International School Augsburg begibt Wandelanleihe als weiteren Finanzierungsbaustein des geplanten Schulneubaus; unserer Einschätzung nach liegen attraktive Konditionen vor und die Anleihe ist von der ISA gAG solide finanzierbar; das Wertpapier ist aus unserer Sicht sowohl für das Unternehmen als auch für die Investoren ein attraktives Investment.

About TREMFYA(TM) (guselkumab) TREMFYA(TM) is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23 and is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).. A Phase 3 study evaluating TREMFYA(TM) in the treatment of active psoriatic arthritis is ongoing, and a Phase 3 program evaluating the efficacy of TREMFYA(TM) compared with Cosentyx(®) (secukinumab) in the treatment of moderate to severe plaque psoriasis is underway.. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA(TM) and may treat you for TB before you begin treatment with TREMFYA(TM) if you have a history of TB or have active TB.. The most common side effects of TREMFYA(TM) include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, and herpes simplex infections.. About STELARA(®) (ustekinumab) STELARA(®) is a human interleukin (IL)-12 and IL-23 antagonist indicated in the U.S. for the treatment of adult patients with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis, alone or in combination with methotrexate; and moderately to severely active Crohn's disease who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA(®), which is currently approved for the treatment of moderate to severe plaque psoriasis in 89 countries, active psoriatic arthritis in 79 countries, pediatric psoriasis in 33 countries and moderately to severely active Crohn's disease in 32 countries.. Common side effects of STELARA(®) include: upper respiratory infections, headache, and tiredness in psoriasis patients; joint pain and nausea in psoriatic arthritis patients; and upper respiratory infections, redness at the injection site, vaginal yeast infections, itching, urinary tract infections, and vomiting in Crohn's disease patients.

(guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).. 2 About TREMFYA ??. TREMFYA ?. ?TREMFYA ?. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA ?. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA ? .. Do not take TREMFYA ?. Before using TREMFYA ?. It is not known if TREMFYA ?. It is not known if TREMFYA ?. TREMFYA ?. Use TREMFYA ?. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics.

HORSHAM, Pa., Sept. 16, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).. DISCOVER-2 included 739 biologic-naïve participants and is planned to continue through 100 weeks..  TREMFYA® may cause serious side effects, including infections.. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: Â.  TREMFYA® may cause serious side effects.. 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 and herpes simplex infections.. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A.. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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