Bimzelx (bimekizumab-bkzx) is a biologic medicine approved by the FDA in 2023. Bimzelx is approved to treat a variety of skin and joint conditions affected by the immune system, including a skin condition called hidradenitis suppurativa. Hidradenitis suppurativa is a chronic inflammatory condition that causes painful bumps under your skin in the hair roots and near sweat glands. It’s also known as acne inversa. The bumps can get infected. When that happens, pockets form under your skin and fill with pus. They can smell bad when they break open. They can also leave scars. There's no cure for hidradenitis suppurativa, but treatments and lifestyle changes can bring some relief and cut down on flare-ups.
How Does Bimzelx Work?
Bimzelx is a type of medicine called a monoclonal antibody. Monoclonal antibodies are human-made antibodies created in the lab to mimic antibodies in the body. Bimzelx works by blocking two naturally occurring proteins called cytokines in the immune system (interleukin [IL]-17A and IL-17F) from interacting with a receptor complex that can cause inflammation in the skin and joints. By stopping these proteins, Bimzelx helps reduce redness, swelling, and scaling of the skin.
How Do I Take Bimzelx for Hidradenitis Suppurativa?
Bimzelx is given as a shot under the skin (subcutaneous injection). 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 to 45 minutes before using it.
The treatment plan usually follows the following steps after the recommended evaluations and vaccines:
- For hidradenitis suppurativa
- Starting dose: 320-mg injection every two weeks for the first 16 weeks
- Ongoing treatment: 320-mg injection every four weeks after the first 16-week phase
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. Bimzelx should be used with the help and guidance of a doctor or health care provider. Adults or caregivers can learn to give the injections at home after proper training.
How Was It Studied for the Treatment of Hidradenitis Suppurativa?
The effectiveness and safety of Bimzelx for hidradenitis suppurativa were studied in two clinical trials (BE HEARD I and BE HEARD II). These studies compared Bimzelx to a placebo (inactive treatment) for 16 weeks, after which all people in the study received Bimzelx. The results showed that Bimzelx helped nearly half of the people in the studies (48% to 52%) reduce their skin bumps and abscesses by at least 50%, while only 29% to 32% of those taking the placebo saw similar improvements. Sustained improvements were maintained for up to a year in those who had seen at least a 50% reduction in symptoms at week 16. Overall, the treatment was generally well-tolerated, with the most common side effects being mild infections, headaches, and diarrhea.
Your results may differ from what was seen in clinical studies.
Who Was Included in These Studies?
Overall, Bimzelx for use in hidradenitis suppurativa treatment has been studied in a variety of people.
How Strong Is the Evidence for Bimzelx?
Based on the current clinical studies, Bimzelx is a safe and effective treatment for people with hidradenitis suppurativa. The United States Hidradenitis Suppurativa Foundation published clinical management guidelines in 2019, but Bimzelx is not included in these guidelines since it was approved by the FDA after these guidelines were published.
How Long Does It Take for Bimzelx to Work?
In studies of Bimzelx for hidradenitis suppurativa, significant improvements were seen within four months (16 weeks) of starting treatment. Studies have also reported that some patients saw a 50% reduction in symptoms as early as two weeks. Your results may differ from what was seen in clinical studies.
Do not stop using Bimzelx 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 medicine.
What Can I Do to 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. Do not inject the drug into 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. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088).
What Types of Drug Interactions Can Happen?
Your body uses special enzymes called CYP450 to break down certain medicines. When you have long-term inflammation, your body may produce more or less of these enzymes, which can change how some medicines work.
Bimzelx may affect the levels of these enzymes, which could impact other medicines you take, especially those that need careful dosing (like warfarin or cyclosporine). If you start or stop taking Bimzelx, your doctor may need to monitor your other medications and adjust the doses if needed.
Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have recently taken. This will help make sure your medicines work well together.
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 Any Cost Assistance 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 www.bimzelx.com/patient-support/navigate-benefits.
