All About Benlysta: A Biologic Treatment for Lupus

In 2011, when the United States Food and Drug Administration (FDA) approved Benlysta (belimumab) it was a big deal! Benlysta was the first drug approved for lupus in over 50 years.  Before then, the only drugs approved by the FDA to treat lupus were Plaquenil (hydroxychloroquine), prednisone (1955), and aspirin (1948). But Plaquenil was not created and is not used only for lupus. It's called an antimalarial drug because it's used to prevent malaria, and it's also used to treat rheumatoid arthritis.

When you hear about Benlysta, you'll often hear the word biologic. Unlike drugs created from chemical processes, a biologic is a drug that is developed from natural sources like animal, human, or microorganism. Benlysta is unique because other biologics have come before it and failed as lupus treatments.

In addition, Benlysta is the first targeted treatment for lupus. Other drugs commonly used to treat lupus—like hydroxychloroquine, corticosteroids, methotrexate, azathioprine, cyclophosphamide, and mycophenolate mofetil—were either designed for other purposes suppress the immune system more broadly. But because Benlysta is a biologic, made up of human proteins, researchers were able to develop a drug that could target a specific part of the immune system that plays a role in triggering lupus symptoms.

As the first targeted biologic lupus treatment, not only does Benlysta offer another treatment option, but it has encouraged more new and innovative lupus research. For these reasons, the FDA's approval of the drug is an important moment in the history of lupus research!

Naturally, someone learning about Benlysta for the first time would be curious to learn more about the drug. Below are answers to common questions about Benlysta.

How Does Benlysta Work?

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According to the Lupus Research Alliance, Benlysta "works by calming down the hyperactive immune system of lupus by inhibiting a protein called 'B lymphocyte stimulator (BLyS)' believed to increase inflammatory reactions that attack and damage the body’s own healthy tissues."

In other words, BLyS is the part of the immune system that the drug targets. Benlysta aims to prevent BLyS from activating the inflammation that causes the immune system to attack a person's own body.

Benlysta is typically used in combination with other lupus medications (standard therapy). The combination has shown to be more effective at decreasing lupus symptoms than standard therapy alone. Reduced symptoms tend to be related to the skin, the mouth, the joints and muscles, and the immune system.

Another possible benefit of the drug is the reduction of corticosteroid use. This is important becase as a long-term treatment, corticosteroids are known to cause side effects like bone loss and organ damage.

How Is Benylsta Administered?

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Unlike most other lupus treatments, Benlysta is not a pill. It is administered by intravenous (IV) infusion. This way it will go directly into the bloodstream and bypass the stomach. If it were swallowed in pill form, it would go into the stomach and important proteins that make up the drug would be destroyed.

Since the drug is administered by IV infusion, this means that you cannot administer the drug at home and have to go somewhere for the infusion like your doctor's office, a hospital or an infusion center. The infusion can take about an hour, but longer if prep and/or observation time is necessary.

For the first three infusions, it's typical for them to happen once every two weeks, and then once every four weeks after that.

Benlysta is intended as a long-term medication, and if you and your doctor agree that it's working well for you, don't stop infusions when you start feeling better. You should continue treatment even after you feel better as a way to maintain its positive benefits.

Also, there are efforts to offer a self-injection option. This would mean you would have the option of administering Benlysta yourself, at home.

I Heard it Doesn't Work for African-Americans

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The original studies that led to Benlysta's approval did not include enough African-American participants. This does not mean that the drug will not work for you if you are African-American. On the contrary, it might work well since everyone with lupus is unique.

There are currently clinical trials underway to help us learn more about how effective Benlysta is for African-Americans. These trials are especially important since African-American women are about three times more likely to develop lupus than white women.

Speak with your doctor if you are interested in trying Benlysta or participating in a Benlysta clinical trial.

What if I Have Organ-Involvement?

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When Benlysta was first approved by the FDA, it was unclear whether the drug would benefit people with organ involvement like lupus nephritis or central nervous system (CNS) lupus. However, in one research analysis, it was found that during the first five years of treatment with Benlysta, the drug did not cause or make organ damage worse, and could possibly slow disease progression related to organ damage. Since this was information based on a single research analysis that combined two studies, more research would be beneficial. The research is promising, so if you have organ involvement and are interested in trying Benlysta, speak with your rheumatologist to see if they think this is a good option for you.

What Are the Side Effects and Risks?

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Like all medications, Benlysta can cause side effects and comes with risks. The drug company must warn of all known possible side effects, but this does not mean that you will experience these. If you are concerned about side effects, it's important to speak with your rheumatologists about your concerns. In cases where people do experience side effects, they might decide to continue treatment if the side effects are not severe or if they and their doctor feel that the benefits of the drug outweigh the side effects.

Because of risks associated with Benlysta, before starting the drug, tell your rheumatologist if you:

  • have signs of or have been diagnosed with an infection, heart disease, or mental illness
  • need or have just gotten a vaccination, especially a live vaccine
  • have medication allergies
  • are taking another biologic medicine, monoclonal antibodies or IV infusions of cyclophosphamide (Cytoxan®)
  • are on any other type of medication, herbal supplement, or vitamin
  • have or have ever had any type of cancer
  • have other medical conditions
  • are pregnant or planning on becoming pregnant, or if you are breastfeeding

This information will help your doctor determine if Benlysta is the right treatment for you and the best time to start treatment. For example, if you have an infection, they would need to postpone treatment since the drug increases infection risk.

If any of these circumstances occur while you are already on the drug, you should tell your rheumatologist, as well.

During clinical trials, people experience side effects, but it is not always clear if the side effects are directly caused by the drug. However, researchers—and in this case GlaxoSmithKiline (GSK), the makers of the drug—must list any negative symptoms that people experience during clinical trials.

The most common Benlysta side effects are

  • nausea
  • diarrhea
  • fever
  • stuffy or runny nose
  • sore throat
  • cough (bronchitis)
  • trouble sleeping
  • leg or arm pain
  • depression
  • headache (migraine)
  • urinary tract infection
  • decreased white blood cell count (leukopenia)
  • vomiting
  • stomach pain

If you experience these or more severe side effects, it's important to tell your rheumatologist right away. If you experience life threatening side effects, like an allergic reaction that restricts your breathing, call 9-1-1 immediately.

There are other possible, less common, side-effects. They are listed on GSK's website, but it's also important to speak with your rheumatologist about Benlysta side effects and risks, in general.

You can also report negative side effects of any prescription drugs, not just Benlysta, to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Will I Be Able to Afford Benlysta?

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Although Benlysta is an expensive treatment option, GSK does provide financial support. Your rheumatologist can work with your insurance and GSK to obtain the financial assistance you will need.

Does Benlysta Work for Children With Lupus?

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It is not yet known if Benlysta is safe and effective for children with lupus.  There is an ongoing pediatric lupus study that is evaluating the effectiveness and safety of Benlysta for children with lupus between the ages of 5-17 years old. If your child has lupus, you can speak with your doctor about whether it is appropriate to enroll them this study.

Are There Still Clinical Trials for Benlysta?

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Yes. If you would like more information about Benlysta clinical trials, you can speak with your rheumatologist or contact GSK directly. You can also visit clinicaltrials.gov and type Benlysta in the search box.

Is it Safe to Take Benlysta for a Long Time?

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Researchers studied the effects of Benlysta in people who have taken the drug for five years and have found that, so far, the drug is safe to take for this amount of time. They did not find an increase in already-known side effects.

What if I'm Pregnant or Want to Breastfeed?

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While there have been women who have have given birth successfully to healthy babies while taking Benlysta, researchers are still studying if it is safe to take Benlysta while pregnant—does the drug get passed onto the fetus and if so, what is the impact? Researchers have collected and analyzed some data but more data is necessary.

If you become pregnant while taking Benlysta or within four months after stopping the drug, tell your rheumatologist right away, and also ask them about the Belimumab (Benlysta™) Pregnancy Registry

Through observations and data collection, the registry is designed to help researchers better understand the impact of Benlysta on pregnancy. You and your baby will also be closely monitored if you decide to stay on the drug.

In some cases, people might decide to stay on Benlysta throughout pregnancy if the benefits of staying on the drug are greater than the negative impact it might have on the baby.

Otherwise, it is recommended to use contraception to prevent pregnancy while taking Benlysta, or up to four months after stopping the drug.

Similarly, it is unknown if the drug passes from parent to baby through breastfeeding. A parent would have to choose between breastfeeding or taking Benlysta. If you are considering breastfeeding, please speak with your rheumatologist who will help you figure out your best option.

How Do I Find Current News About Benlysta?

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To find out about any recent research or news related to Benlysta, you can speak with your doctor. You can also do an internet search, making sure to find reliable sources.

In your preferred search engine, you can enter a search term like Benlysta research 2016 (use the current year).

The first few search results will possibly include links to the Lupus Research Alliance, or other reputable lupus organizations. Examples of reliable lupus research news websites are MedPage Today and Lupus News Today. These might also come up in your search. (Learn more about how to find reliable health information on the internet.)

You might come across articles published by GSK. It's always helpful to go directly to the pharmaceutical company and see what press releases they've recently published about a particular treatment.

If you want to go directly to the research, PubMed is a United States government website that provides free access to the National Library of Medicine database called Medline. Sometimes it provides complete articles. Other times it provides abstracts. An abstract is a summary of the article.

If you do a search on PubMeb for Benlysta, you will get many results. You could narrow down the results by adding to your search term. Instead of searching for Benlysta, search for Benlysta side effects, for example.

Is Benlysta Available Outside the U.S.?

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In addition to being available in the United States, Benlysta is available across six continents - North and South America, Africa, Asia, Europe, and Australia. To find out if Benlysta is available in your specific country, speak with your rheumatologist. You can also call GSK. To contact them if you live outside of the U.S., visit their website's Worldwide section and search by region.

Will Benlysta Work for Me?

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Everyone with lupus is a unique individual, so there is no simple answer to this question. 

Speak with your rheumatologist to find out if they think you are a good candidate for this treatment.

If you and your rheumatologist think it is a good treatment option, you will have to try the drug to see how it works for you. Keep in mind that it does not work as immediately as a treatment like corticosteroids. It can take weeks or months to start seeing results.

Considering Benlysta? Speak With Your Rheumatologist

If you are considering Benlysta, the next step is to speak with your rheumatologist. You will naturally have many questions during your initial conversation about the treatment, as well as at any point after that, including while you are taking the drug. Write down your questions as they arise, and bring your list of questions to your next appointment. You can also call GSK directly through the BENLYSTA Gateway at 1-877-4-BENLYSTA (1-877-423-6597) Monday through Friday, 8 AM to 8 PM Eastern Time. When it comes to your health, your have the right to be as informed as possible.

Sources: 

Bruce I, Urowitz M, Vollenhoven R, et al. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016; 0: 1-11. http://lup.sagepub.com/content/early/2016/02/18/0961203315625119.full.pdf+html.

Dubey A, Handu S, Dubey S, Sharma P, Sharma K, Ahmed Q. Belimumab: First Targeted Biological Treatment for Systemic Lupus Erythematosus. Journal of Pharmacology & Pharmacotherapeutics. 2011; Oct-Dec; 2(4): 317–319. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3198539/.

Landy H, Powell M, Hill D, Eudy A, Petri M. Belimumab Pregnancy Registry: Prospective Cohort Study of Pregnancy Outcomes. Obstetrics & Gynecology. 2014; 123(1). http://journals.lww.com/greenjournal/Abstract/2014/05001/Belimumab_Pregnancy_Registry__Prospective_Cohort.130.aspx.

Vollenhoven R, Petri M, Wallace J, et al. Cumulative Corticosteroid Dose Over Fifty-Two Weeks in Patients With Systemic Lupus Erythematosus: Pooled Analyses From the Phase III Belimumab Trials. Arthritis & Rheumatology. 2016; 68(9): 2184–2192. http://onlinelibrary.wiley.com/doi/10.1002/art.39682/abstract.