Banner: About BENLYSTA

What is BENLYSTA?

Erica

Actual patient
receiving BENLYSTA

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What Kind of Medicine is BENLYSTA?

BENLYSTA (belimumab) is a biologic therapy, not a steroid. It is taken in addition to your other lupus medications and is available in three options:

  • an autoinjector you self-inject, for adults
  • a prefilled syringe you self-inject, for adults
  • an intravenous (IV) infusion a healthcare provider administers, for adults and children ages 5 and above

Talk to your doctor to see if BENLYSTA is right for you.

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What’s Different About BENLYSTA?

Unlike other medicines used to treat lupus, BENLYSTA was specifically designed for lupus. In fact, it is the first and only approved treatment designed for lupus. 

In many people with lupus, certain white blood cells called autoreactive B cells (cells that react against the body) stay in the body longer than they should. One of the important proteins for the growth of these cells is called B-lymphocyte stimulator, or BLyS. BENLYSTA binds to BLyS and prevents it from stimulating B cells.

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The Benefits of BENLYSTA

Adult Patients
In studies used in the approval of BENLYSTA,* when added to other medicines commonly used to treat lupus, compared to other lupus medicines alone, BENLYSTA has demonstrated:

Superior reduction in disease activity
Mainly due to improvements in the immune system, muscles, mouth, joints, and skin

Superior reduction in the chance of severe flares 
Reduction in the chance of severe flares occurred in two of the three studies†

Reduction in steroid dose‡
By 25% or more (to a daily dose of 7.5 mg or less) during Weeks 40-52, in patients receiving 7.5 mg or higher daily doses of steroid at the start of the study

* BLISS-52, BLISS-76, and BLISS-SC.

† A superior reduction in the chance of severe flares did not occur in the BLISS-76 trial.

‡ A numerical reduction in daily steroid dose was observed, but this difference was not big enough for researchers to be sure that BENLYSTA was better than the placebo when added to patients’ current lupus medicine(s).

Your results may vary.

Pediatric Patients (5 years and above)
When added to other medicines commonly used to treat lupus, compared to those medicines alone, BENLYSTA IV has been observed to§:

Reduce lupus disease activity

Reduce the chance of severe flares

§ Because lupus doesn’t occur in children very often, the pediatric study had a much smaller number of patients than the adult studies of BENLYSTA. The study in children was still able to support that BENLYSTA worked, with results similar to those from the adult studies. Due to the small size of the study, however, there was no way to confirm the effect or the consistency of the results.

Please note that these are findings based upon a study in pediatric patients.
Your child’s individual results may vary.

HOW TO TAKE BENLYSTA

 

Studied in Multiple Clinical Trials

BENLYSTA has been studied for FDA approval in the largest successfully completed series of adult lupus clinical trials ever conducted.

 

Study

Characteristics

BLISS-SC

Evaluated the efficacy, safety, and tolerability of BENLYSTA subcutaneous (SC) + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 52 weeks.

BLISS-52

Evaluated the efficacy, safety, and tolerability of BENLYSTA intravenous (IV) infusion + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 52 weeks.

BLISS-76

Evaluated the efficacy, safety, and tolerability of BENLYSTA intravenous (IV) infusion + other lupus medicines compared to other lupus medicines alone in adult patients with active SLE.

Duration: 76 weeks.

These adult trials showed that people treated with a combination of BENLYSTA and other lupus medicines experienced a superior reduction in disease activity at Week 52 compared to people who received the other lupus medicines alone.

Additionally, BENLYSTA was studied in the first pediatric lupus clinical trial ever conducted.

Study

Characteristics

PLUTO

Evaluated the efficacy, safety, and pharmacokinetics of BENLYSTA intravenous infusion (IV) + other lupus medicines compared to other lupus medicines alone in children and adolescents (5-17 years) with active SLE.

Are you ready to learn more about BENLYSTA?

Register for Your Free Information Kit

How BENLYSTA Works

Watch this short video to learn more about what lupus is, how it affects the body, and how BENLYSTA works.

TRANSCRIPT

Narrator: The human immune system is made up of organs and lymphatic vessels and nodes. It also consists of cells and a wide range of chemical messengers and other proteins that are produced by these cells of the immune system. This is the system that helps protect us from infections caused by bacteria, viruses, and other germs. B cells, a type of white blood cell, are an important component of the immune system. These cells recognize and fight germs by producing a special type of protein called an antibody. Antibodies recognize and latch onto germs. This attachment is a key step in how the immune system protects from infection and fights infection. Working together, the many parts of the immune system play a vital role in maintaining health.

When the immune system is not working properly, however, it can cause illness rather than help maintain health. Systemic lupus erythematosus, or SLE, is one of many diseases caused by abnormal immune system activity. In many people with lupus, certain B cells remain in the body longer than they should. These cells, called autoreactive B cells, play a role in causing lupus. Like other B cells, autoreactive B cells can produce antibodies. But the antibodies released by autoreactive B cells do not fight germs. Instead, these antibodies, which are called autoantibodies, attach to normal tissues inside the body. When this happens, the autoantibodies end up attacking your own body and tissues can become inflamed.

All of the cells of the immune system are influenced by chemical messengers. For example, one of the chemical messengers that binds to and helps the growth of B cells – including autoreactive B cells – is called BLyS. BLyS is short for B lymphocyte stimulator. BENLYSTA works by binding to BLyS. When BENLYSTA is attached to BLyS, BLyS can no longer bind to and stimulate the autoreactive B cells. Adding BENLYSTA to your other lupus treatments may help reduce the abnormal immune system activity that contributes to disease activity in lupus.

See the BENLYSTA Experience from their perspective

Learn from other patients as they share their struggles with lupus and discuss their experiences with BENLYSTA.

TRANSCRIPT

Morgan: I was excited to try BENLYSTA, but I wasn’t sure I would be covered by my parents’ insurance plan, and if I could manage the costs. My doctor told me about BENLYSTA Gateway, helped me complete the enrollment form, and suggested that I give them a call. The person who answered the phone told me about the BENLYSTA Co-pay Assistance Program.

Susan: As soon as my physician told me to consider BENLYSTA, he sent me over to the infusion center to talk with some of the nurses there. My nurse also mentioned that I could call BENLYSTA Gateway any time I needed. When I did, I definitely found the people there to be very helpful and compassionate. They helped me with everything I needed to know.

I honestly don’t think I could be where I am today without my parents and friends. When you have a chronic illness like lupus – one that’s so unpredictable – having a good support system is really important. I mean, there may be days when you just don’t feel well enough to do much of anything. So having that one or more people that you feel comfortable with – people that you can really depend on – is very helpful.

Michelle: I think it’s really important to have an open line of communication with your rheumatologist. It really wasn’t until I was able to open up to my doctor and talk to her about everything that was going on with me with my symptoms – what was working and what wasn’t working. And only at that point were we able to find a treatment strategy that was able to help me.

Morgan: My advice for other lupus patients is to be your own advocate. You need to make your own personal decisions. Remember, it’s a disease, not who you are. So live your life. Find something you’re passionate about – like a hobby – something worth getting out of bed for every day. For me, it’s my wonderful dogs.

Susan: Get educated – learn everything you can about lupus – and about BENLYSTA. Talk to people, read articles, ask questions, go online. I find BENLYSTA.com a really great resource.

Michelle: Stay positive. Continue to be your own best advocate, and find what works for you, as an individual person with lupus. Don’t let lupus define you. You are still you. And never be afraid of asking for help when you need it.

Frequently Asked Questions

  • Do I need to take BENLYSTA with lupus medicines?

    Yes. BENLYSTA is used to treat children ages 5 and above and adults with active SLE who are receiving other lupus medicines. Intravenous dosing of BENLYSTA is approved for patients 5 years and older, and subcutaneous dosing is only approved for adults. It is not known if BENLYSTA is safe and effective in people with severe active lupus nephritis or severe active central nervous system lupus.

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  • How is BENLYSTA administered?

    BENLYSTA is either given by intravenous (IV) infusion (for children ages 5 and above and adults) every 2 weeks for the first three doses and then every 4 weeks thereafter or injected subcutaneously (SC) (for adults only) once a week, either with an autoinjector or a prefilled syringe.

    It is not available in pill form. 

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  • How many patients were included in the clinical trials with BENLYSTA?

    BENLYSTA has been studied in multiple clinical trials involving more than 2,500 adult patients, over 1,100 of whom were treated with BENLYSTA. To date, the pediatric program has included 93 children. BENLYSTA has the largest lupus clinical trial program to date. 

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  • What are the most common side effects of BENLYSTA?

    The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, persistent cough, trouble sleeping, leg or arm pain, depression, headache, pain, redness, itching, or swelling at the site of injection (when given subcutaneously).

     

    These are not all the possible side effects of BENLYSTA. Talk to your healthcare provider for medical advice about side effects.

     

    Risks and side effects

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  • Can taking BENLYSTA make it easier for me to get an infection?

    BENLYSTA can cause serious side effects including infections. Symptoms of an infection can include fever, urinating often, chills, coughing up mucus, pain or burning with urination, and warm, red, or painful skin or sores on your body. Tell your healthcare provider right away if you have any of the symptoms listed above while receiving BENLYSTA.

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Looking for a physician?

If you are looking to find a lupus physician to help you or a loved one take the next step with BENLYSTA, we are here to help.

FIND A PHYSICIAN NEAR YOU

Looking for coverage assistance?

When you start BENLYSTA treatment, you also have access to help understanding your health insurance coverage with BENLYSTA Gateway & Co-pay Program. LEARN ABOUT YOUR COVERAGE OPTIONS