People with lupus often need to use medicines to manage their symptoms. Although there are many oral medicines that treat lupus, some people with more severe symptoms may not get enough benefit from them. Benlysta is a different type of medicine, called a biologic, that may reduce symptoms in some of these people.
How Does Benlysta Work for Lupus?
Systemic lupus erythematosus (SLE), more commonly known as lupus, is an autoimmune disorder, which means that a person’s immune system attacks the healthy cells in their body. In people with lupus, the immune system may attack many different parts of the body, including the skin, the joints, and certain organs. This causes swelling (inflammation) that can lead to different symptoms depending on which part of the body is affected.
Many people with lupus feel very tired and may have headaches and low fevers. Most people also have symptoms related to their skin and hair, such as sensitivity to sunlight, a butterfly-shaped rash on the face, sores in the mouth or nose, or hair loss. Some people may experience pain in their joints, pain in the chest while taking a deep breath, or swelling in the hands, feet, and around the eyes. Over time, lupus can cause damage to the heart or kidneys, which can increase the risk for heart and kidney disease.
Some people with lupus may have relatively mild symptoms whereas others may have very severe symptoms. For many people, symptoms will change over time. Many people will have flare-ups when symptoms become much worse for weeks or months. Some people may have periods of remission when their symptoms go away for some length of time. If a person is experiencing lupus symptoms, their disease is considered active at that time.
The first step to treating lupus is to manage symptoms through lifestyle changes, exercise, diet, and certain medicines. But the key to treating lupus over time is to use medicines that slow down the attacks from the immune system. Oral corticosteroids (such as prednisone) are commonly used for this purpose. Many people also take a medicine that was originally used to treat malaria, such as hydroxychloroquine (Plaquenil). There are also many medicines that limit the activity of the entire immune system (immunosuppressants), such as azathioprine, methotrexate, and mycophenolate (Cellcept).
Benlysta is a different type of medicine called a biologic. Belimumab, the active ingredient in Benlysta, targets a specific type of cell in the immune system that plays a major role in lupus called the B cell. Benlysta blocks a substance called B lymphocyte stimulator (BLyS) from binding to B cells, which reduces the number of B cells in the body. This can help to reduce swelling and symptoms in people with lupus.
Can Anyone With Lupus Use Benlysta?
Benlysta is approved for use in people with lupus who still have symptoms even though they are already taking other medicines to treat their overactive immune system. If you are already using other medicines and are still having difficult symptoms, your specialist may discuss a medicine like Benlysta with you.
Benlysta may not be a safe option for everyone. For example, it is not recommended for people who have severe lupus in the central nervous system, which can cause symptoms like seizures and stroke. Make sure that your health care provider knows about any past or current medical conditions, especially specific conditions such as depression and cancer.
How Was It Studied in Adults?
Three large studies were done to see if Benlysta is safe and effective for the treatment of lupus in adults. Everyone in these studies was at least 18 years old, with an average age of about 35-40. Most of the people (95%) in these studies were female. About 37% were White, 27% were Black, 18% were Native American, and 17% were Asian. About 20% of the people in these studies identified as Hispanic or Latino.
All of the people in these studies had active lupus and high levels of a certain marker in their blood called antinuclear antibody (ANA). To manage their symptoms, most (86%) were taking oral corticosteroids every day, about 69% were taking a malaria medicine, and half (50%) were taking oral immunosuppressants.
These studies measured efficacy by counting the number of people who “responded” to treatment. A treatment response means that a person’s condition improved by a certain amount during the study. In these studies, a treatment response meant that a person had their symptoms improve by a certain amount, had no new severe flare-ups, and had no more than one moderate flare-up during the study.
In all of these studies, Benlysta was compared with a placebo. No one knew whether they were receiving the medicine or the placebo. If anyone was taking oral medicines to treat lupus before the study started, they kept taking those medicines during the study.
What Benefits Were Seen in the Studies?
Treatment response. All three studies counted how many people had a response to treatment after 1 year in the study.
- In two of these studies, the people who used Benlysta were more likely to respond to treatment after 1 year than the people who used a placebo. About 43%-58% of people who used Benlysta had a response to treatment, compared with about 34%-44% of people who used a placebo.
- A third study specifically looked at how well Benlysta worked for Black people with lupus and whether it was safe. After a year, more people had a response to treatment with Benlysta compared to a placebo. However, it wasn't enough of a difference to know if the results were due to chance. Overall, this study showed that Benlysta's safety was similar to previous studies and this medicine could be an option for treating lupus in people who identify as Black. It isn't clear from this study whether Benlysta is more or less effective in Black people.
How Was It Studied in Children?
One clinical study was done to see if Benlysta is safe and effective for the treatment of lupus in children 5-17 years old. Most (86%) of the children were between the ages of 12-17, and most (95%) were female. The race of the children in this study was not reported.
Everyone in this study had active lupus when the study started. Almost everyone (95%) was taking oral corticosteroids every day to manage their symptoms, most (81%) were taking a malaria medicine, and about two-thirds (65%) were taking oral immunosuppressants.
This study used a tool similar to the one used in the studies in adults to measure how many people had a treatment response. Benlysta was compared with a placebo, and no one knew if they were receiving the medicine or the placebo. After one year in the study, more of the children using Benlysta responded to treatment (53%) than those using placebo (44%).
How Quickly Will Benlysta Work for Lupus?
If Benlysta is working, your symptoms may start to improve during the first month of treatment. Most people see the greatest improvements during the first 4 months of treatment. Over time, this should mean that your symptoms are less severe and that you do not experience as many moderate to severe flare-ups.
Do not stop using Benlysta or any other medicines for lupus without talking to your health care provider first, even if your symptoms have gotten better. Your symptoms may get worse again if you stop or change any of your medicines.
Tell your health care provider if your symptoms do not seem to be improving after about 4 months of using Benlysta. Your health care provider may discuss other options for treating this condition.
How Do I Use It?
Benlysta is a liquid that can be injected into the body in two ways:
- As an infusion into a vein (IV) at a health care facility. You will receive an infusion every 2 weeks for the first three doses. Then you will receive an infusion every 4 weeks.
- As an injection under the skin. With proper training, these injections can be given at home. For adults, they are given every week. For children, they may be given every week or every other week, depending on the child’s weight.
In certain cases, your health care provider may recommend that you receive this medicine as an IV in a health care facility. You may also request this option if you would prefer to receive the infusion in a facility instead of giving the injections at home. If you change your mind in the future, your health care provider can work with you to switch from the IV infusion to the injections given at home.
If you are giving the injection at home, Benlysta comes in two different forms. The most common form is a prefilled device called an autoinjector. It is ready to be injected under the skin, so you do not need to learn how to use a syringe and needle. The medicine also comes in a pre-filled syringe with a needle. These injections are given under the skin of the thigh, stomach, or outer area of the upper arm. Your health care provider will show you how to inject the medicine the first time. Your prescription will also come with detailed “Instructions for Use,” which provide step-by-step guidance on how to use the medicine. It is important to follow each of these steps to ensure that you get the full dose of your medicine each time.
How Can I Prevent or Manage Side Effects?
In rare cases, some people may have a serious allergic reaction (anaphylaxis) to Benlysta. These reactions may be more likely to happen in people who have allergies to many other medicines or who have had a serious allergic reaction to another medicine in the past. Your first dose of the medicine will be given in a health care facility so that a health care professional can monitor you for an allergic reaction. They will also educate you on how to monitor for signs of an allergic reaction with future doses.
When injected under the skin, Benlysta can cause a skin reaction at the injection site, which may involve redness, pain, itching, and swelling. One way to reduce these reactions is to inject the drug into a different part of the body each time, which is called “rotating” the injection site. For example, Benlysta can be injected into different parts of the thigh, stomach, or outer area of the upper arms. Don’t inject the drug into skin that is already tender, damaged, bruised, or scarred.
People who use Benlysta are more likely to have infections, especially an infection of the airways. These include infections in the nose or throat, a sore throat, or common cold symptoms. The best way to prevent infection is to reduce your exposure to germs by washing your hands and avoiding people who are sick. You should also stay current on vaccinations, such as getting an annual flu shot. Before you start Benlysta, speak with your health care provider about whether you are due for any vaccines.
In some people, Benlysta may cause depression and suicidal thoughts. Following a daily schedule that includes exercise and a well-balanced diet can help manage symptoms of depression. It may also help to write down how you are feeling and keep track of your moods and mental state. Let your health care provider know right away if you are experiencing any thoughts of suicide or death, changes in your mood or behavior, or new or increased feelings of anxiety or depression. If you are thinking of harming yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline.
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Benlysta, you can also report side effects to the FDA at 800-FDA-1088.
Are There Any Interactions With Other Medicines?
It is important for your health care provider to be aware of all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
It is especially important to let your health care provider know if you are using any other biologic medicines, such as rituximab (Rituxan). Using multiple biologic medicines together may increase the risk of side effects.
Are There Any Interactions With Vaccines?
It is important to discuss any recent or upcoming vaccines (immunizations) with your health care provider. There are certain vaccines (“live” vaccines) that you should not receive either right before starting Benlysta or once you have already started using it. Your health care provider will confirm whether any recent or upcoming vaccines are safe.
Are There Any Special Steps Required to Get Benlysta?
Benlysta is a type of medicine called a “specialty” medicine. This means that it may require prior authorization from your insurance company. If you will be giving the injections at home, you may need to get the medicine from a specialty pharmacy.
Is There a Coupon Card Available?
There is a savings coupon available from the manufacturer that may help to reduce the cost of the medicine. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.benlystacopayprogram.com.
