Although some people with plaque psoriasis can control their symptoms by using topical treatments that are applied to the skin, some people with moderate or severe plaque psoriasis do not get enough benefit from these treatments. In these cases, medicines that are taken by mouth or injected into the body may be needed. These medicines act directly on the body’s immune system to help reduce symptoms.
In 2023, Bimzelx was approved for the treatment of moderate or severe plaque psoriasis. Clinical studies show that this injectable medicine may improve symptoms more than some of the other injectable medicines that have been approved for this purpose in the past.
How Does Bimzelx Work for Plaque Psoriasis?
Plaque psoriasis, the most common form of psoriasis, is a type of autoimmune condition where the body’s immune cells attack its own healthy cells. In people with plaque psoriasis, the immune system attacks healthy skin cells, which causes swelling (inflammation). This can make too many skin cells form on the skin, causing discolored patches. These patches, which are known as “plaques,” are sections of thick, raised skin that may be covered with a thin silvery-white scale.
For many people, these plaques will be itchy and uncomfortable. But it is important not to scratch the itchy areas, since scratching can cause the plaques to get bigger and thicker. Plaques most often appear on the scalp, elbows, knees, and lower back, although some people may get plaques on other parts of the body as well.
People with plaque psoriasis have “flare-ups,” or times when their symptoms are most noticeable. These flare-ups can last weeks or even months. Many “triggers” can make psoriasis worse or cause a flare-up, including certain medicines. An infection, such as a cold or the flu, can also trigger a flare-up. Some other common triggers include:
- Dry and/or cold weather
- Stress
- Skin injuries, such as cuts or severe sunburns
- Smoking
- Drinking large amounts of alcohol
For most people, the key to treating plaque psoriasis is to avoid triggers, moisturize the skin, and apply topical treatments as prescribed. But this does not always work for people with very bad symptoms. People with more severe plaque psoriasis may need more treatments that target the body’s overactive immune system.
The active ingredient in Bimzelx is a medicine called bimekizumab. This medicine blocks two substances in the body from working, called interleukin-17 (IL-17) A and F. Many people with plaque psoriasis have too much of these substances, which can increase swelling. By blocking IL-17A and IL-17F, Bimzelx can reduce swelling in people with plaque psoriasis, easing symptoms.
How Do I Use It?
Bimzelx is a liquid that is injected under the skin. When you start using this medicine, you will have a shot every 4 weeks for four doses. After that, you will have a shot every 8 weeks. Each dose requires two shots, which are typically given into two different parts of the body. Each shot can be given into the thigh, stomach, or outer area of the upper arm.
This medicine comes in two 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. The medicine also comes in a pre-filled syringe with a needle. Since the medicine is stored in the refrigerator, it is helpful to let it warm up to room temperature for 30-45 minutes before using it. Your health care provider will show you how to inject the medicine before you use it the first time.
It is important to inject the medicine properly so that you get the right dose. Your prescription should come with “Instructions for Use,” which explains how to prepare and give a dose. Ask your pharmacist or other health care provider if you are unsure how to use it.
Can Anyone With Plaque Psoriasis Use Bimzelx?
People with moderate or severe plaque psoriasis may not get enough benefit from topical treatments and may need to consider other options, such as oral or injected medicines, or a type of treatment called light therapy. If you are not able to manage your symptoms with topical treatments, Bimzelx may be an option to discuss with your health care provider.
Bimzelx 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. In particular, be sure to let them know if you have inflammatory bowel disease (IBD), which includes ulcerative colitis and Crohn’s disease. It is also important for your health care provider to know if you have recently traveled to other countries, or if you have been around someone who has had a serious infection such as tuberculosis (TB).
How Was It Studied?
Three studies were done to see if Bimzelx is safe and effective for the treatment of plaque psoriasis. All of the people in these studies had moderate to severe plaque psoriasis and had been diagnosed about 18 years, on average, before the study started. Everyone was at least 18 years old, with an average age of about 45. Most (71%) of the people in these studies were male and most (84%) were White. Two of the studies did not report the race of the other people. In the one study that did report the race of each person, about 22% were Asian, about 2% were Black, and less than 1% were Native American or Alaska Native.
Here is some other important information about these studies:
- One study compared Bimzelx with a placebo. No one in the study knew whether they were receiving the medicine or the placebo.
- One study compared Bimzelx with another medicine called adalimumab (Humira). Adalimumab, which is injected into the body, is approved for the treatment of plaque psoriasis and works by blocking a substance in the body called tumor necrosis factor (TNF). No one in the study knew which medicine they were receiving.
- One study compared Bimzelx with a placebo or another medicine called ustekinumab (Stelara). Ustekinumab, which is injected into the body, is approved for the treatment of plaque psoriasis and works by blocking multiple substances in the body. No one knew if they were receiving Bimzelx, ustekinumab, or a placebo.
All of these studies measured efficacy in two ways:
- The number of people whose symptoms improved by at least 90% during the study
- The number of people whose symptoms improved on a scale called the Investigator Global Assessment (IGA). A health care provider rates a person’s plaque psoriasis symptoms on this scale from 0 to 4. A score of 0 or 1 means that the skin is completely or almost completely clear of plaques. A score of 4 means that symptoms are severe.
What Benefits Were Seen in These Studies?
Improvement in symptoms. After 4 months in the study, the people who used Bimzelx were more likely to have their symptoms improve by at least 90% from where they were before the study started. Most (85%-91%) of the people who used Bimzelx had their symptoms improve by this much. Here are the percentages of people who had their symptoms improve by 90% or more while receiving the other treatments used in these studies:
- Adalimumab: 47%
- Ustekinumab: 50%
- Placebo: ≤5%
This means that Bimzelx worked better than any of these other options for improving symptoms.
The number of people with clear or almost clear skin. After 4 months in the study, the people who used Bimzelx were more likely to have clear or almost-clear skin (a score of 0 or 1 on the IGA). Most (84%-93%) of the people who used Bimzelx had this score. Here are the percentages of people who had clear or almost-clear skin while receiving the other treatments used in these studies:
- Adalimumab: 57%
- Ustekinumab: 53%
- Placebo: ≤5%
This means that Bimzelx worked better than any of these other options for clearing the skin.
How Quickly Will Bimzelx Work for Plaque Psoriasis?
If Bimzelx is working, your symptoms will start to improve over the first few months. Most people see the greatest improvements during the second and third months of taking the medicine. Some people may continue to see some improvement during the fourth month as well.
Do not stop using this or any other medicines for plaque psoriasis 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 2-3 months of using Bimzelx. Your health care provider may discuss other options for treating this condition.
How Can I Prevent or Manage Side Effects?
Bimzelx can cause a skin reaction where you get the shot, which may involve redness, pain, bruising, and swelling. 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 the drug into a psoriasis plaque or any skin that is already tender, damaged, bruised, or scarred.
People who use Bimzelx 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 vaccine. Before you start Bimzelx, speak with your health care professional about whether you are due for any vaccines.
In some people, Bimzelx may cause depression and suicidal thoughts. Following a daily schedule that includes exercise and a well-balanced diet can help with this. 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 having 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 Bimzelx, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
Are There Any Interactions With Other Medicines?
Bimzelx may alter the blood levels of some 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.
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 Bimzelx 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 Bimzelx?
Bimzelx 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.
Is There a Coupon Card Available?
There is a savings coupon available from the drugmaker that may allow you to pay as little as $5 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 https://www.bimzelx.com/patient-support/navigate-benefits.
