People with rheumatoid arthritis often take medicines to help manage their condition and improve their symptoms. Some of these medicines work directly on the body’s immune system and help to limit the swelling (inflammation) that causes damage to the joints over time.
Some people will be able to manage their condition with oral medicines. For people with more serious forms of the condition, or people who do not get enough benefit from oral medicines, many medicines that are injected into the body may be an option. One of these medicines, called Enbrel, was the first injected medicine to be approved for rheumatoid arthritis.
How Does Enbrel Work for Rheumatoid Arthritis?
Rheumatoid arthritis (RA) is a type of autoimmune condition, which means that the body’s immune system attacks its own healthy cells. In people with RA, the immune system attacks the lining in the joints, which causes swelling (inflammation). This can cause the joints to become red, warm, stiff, and painful. Over time, the swelling can cause permanent damage, which can make the joints very painful and difficult to use. Although RA may start in only a couple of joints, it can spread to other joints if it is not treated. It most commonly causes issues in the wrists, hands, elbows, shoulders, feet, and knees.
Everyone with RA has a different experience. If a person with RA is having symptoms, their disease is considered “active.” Some people with this condition will have their symptoms come and go over time. These people have periods of “remission,” when the pain or stiffness goes away for a while. Many people with RA will have “flare-ups,” where symptoms become much worse. These flare-ups may be due to stress, too much activity, or changes in treatment.
The key to treating RA is to reduce the swelling in the joints. This can help to reduce pain and stiffness. It can also help to prevent permanent damage to the joints. It is important to start treatment for RA as soon as possible after receiving a diagnosis, so that the damage to the joints does not become severe.
There are certain medicines available that help to stop the immune system from attacking its own cells and causing swelling. Since these medicines prevent damage to the joints over time, they are called disease-modifying antirheumatic drugs (DMARDs). Some of these medicines are taken by mouth and others are injected into the body. People with RA often take more than one DMARD. They may also take other medicines to help manage the pain and swelling in their joints.
Enbrel is a DMARD that is injected into the body. The main ingredient in Enbrel is called etanercept. This medicine works by blocking a substance in the body, called tumor necrosis factor (TNF), from working. People with RA have too much TNF activity. Blocking TNF from working can decrease the swelling in the joints, preventing damage and reducing pain and stiffness.
Can Anyone With RA Use Enbrel?
Enbrel is approved for use in people with moderate or severe RA. Many people who use it may already have tried DMARDs that are taken by mouth. Some people who start Enbrel will still continue to take DMARDs by mouth, and others may not. Your specialist will work with you to find the best treatment plan.
Enbrel may not be a safe option for everyone. It is important to speak with your health care provider about any past or current medical conditions, especially specific conditions such as:
- Multiple sclerosis
- Optic neuritis
- Granulomatosis with polyangiitis
- Alcoholic liver disease
It is also important for your health care provider to know if you have recently traveled to different parts of the U.S. or to other countries, or if you have recently been around someone who has had a serious infection, such as chickenpox or tuberculosis (TB).
How Was It Studied?
Multiple clinical studies were done to see if Enbrel was safe and effective for the treatment of RA. Everyone in these studies had active RA, and most of the people in these studies had already used an oral DMARD. Some of the oral DMARDs that people had used were methotrexate (MTX), sulfasalazine, and hydroxychloroquine. Most of the people in these studies had also taken an oral corticosteroid, which is a medicine that helps reduce swelling.
Everyone in these studies was at least 18 years old, with an average age of 50-53. Most of the people (about 76%) were female and most (about 80%-90%) were White. The race of the other people in these studies was not reported. Here is some other important information about these studies:
- In two studies, Enbrel was compared with a placebo. No one knew whether they were using the medicine or the placebo. In one of these studies, everyone was already using MTX and was told to continue using it during the study. In the other study, people were told to stop their oral DMARDs.
- In two studies, Enbrel was compared with MTX. Some of the people used Enbrel, some people used MTX, and some people used both of these medicines together. No one in these studies knew which medicine(s) they were taking.
These studies measured efficacy by looking at how much a person’s symptoms improved. This was done by counting how many tender and swollen joints a person had before and during the study. Patients and health care professionals were also asked to rate symptoms on a scale throughout the study. If a person’s symptoms improve by at least 20%, this is considered a meaningful change.
What Benefits Were Seen in These Studies?
Change in symptoms. In the studies that compared the medicine to a placebo, the people who used Enbrel had more improvements in their symptoms than the people who used the placebo. In the studies that compared the medicine to MTX, the people who used Enbrel had more improvements in their symptoms than the people who used MTX.
More people who used Enbrel had their symptoms improve by at least 20% than the people who used either a placebo or MTX. There were also more people who used Enbrel who had their symptoms improve by much larger amounts, such as at least 50% or 70%, than the people who used a placebo or MTX.
In the studies where people took Enbrel and MTX together, this combination of medicines worked better than the placebo. This combination also worked better than using either of the medicines alone.
How Quickly Will Enbrel Work for Rheumatoid Arthritis?
If Enbrel is working, your symptoms may start to improve within the first few weeks of treatment. Symptoms should continue to improve over the next 6-12 months. This means that you should have fewer painful, swollen joints and should also feel better overall.
Do not stop using this or any other medicines for RA 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 Enbrel does not seem to be improving your symptoms after 3-4 months. Your health care provider may discuss other options for treating this condition.
How Do I Use It?
Enbrel is a liquid that is injected under the skin every week. It can be injected into the thigh, stomach, or outer area of the upper arm. The medicine is stored in the refrigerator. To make the shot more pleasant, it is helpful to let the medicine warm up to room temperature for 15-30 minutes before using it.
The medicine comes in different forms. The most common form is a pre-filled device that is ready to be injected under the skin, so you do not need to learn how to use a syringe and needle. This device is called an autoinjector. The medicine also comes in a pre-filled cartridge (called Enbrel Mini), which is placed into an autoinjector device called the AutoTouch.
Your health care provider will show you how to inject the medicine before you use it the first time. It is important to inject it properly so that you get the right dose. Your prescription should also come with “Instructions for Use,” which explains how to prepare and give a dose. If you are unsure how to use the medicine, speak with your health care professional or pharmacist.
How Can I Prevent or Manage Side Effects?
Enbrel can cause a skin reaction where you get the shot, which may involve redness, pain, swelling, and/or bruising. These reactions are most common during the first month of treatment but can happen with later doses as well. One way to reduce these reactions is to inject the medicine into a different part of the body each time, which is called “rotating” the injection site. For example, it can be injected into different parts of the thigh, stomach, or outer area of the upper arms. Don’t inject it into skin that is already tender, damaged, bruised, or scarred.
People who use Enbrel are more likely to have infections, especially an infection of the airways. These include sinus infections, 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 vaccine. Before you start this medicine, speak with your health care professional about whether you are due for any vaccines.
Some types of microbes that cause infections (such as viruses and bacteria) can stay in the body even after you have recovered from an infection. When this happens, the microbes are considered “latent,” which means they are not active and do not cause infection. In some cases, Enbrel may cause these microbes to reactivate and cause a new infection. Before starting treatment, it is important to let your health care provider know if you have had any serious infections in the past, such as tuberculosis (TB), hepatitis B, or histoplasmosis. You and your health care provider can discuss a plan to use Enbrel safely or to consider other treatment options.
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 Enbrel, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
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 medicines that may affect the function of your immune system.
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 Enbrel or after 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 This Medicine?
Enbrel is a “specialty” medicine. This means that you can only get it from a specialty pharmacy and that it may require prior authorization from your insurance company. Your first dose will always be given by a health care provider in a health care setting.
Is There a Coupon Card Available?
There is a savings coupon available from the drugmaker that may allow you to pay $0 for your prescription. 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.enbrel.com/support.
