Bimzelx is a biologic medication (made from living cells) called a monoclonal antibody. Monoclonal antibodies are proteins made in a lab to act like the antibodies your body makes. In your body, antibodies recognize and attach to certain targets — like germs — so your immune system can fight them. Bimzelx attaches to two proteins and stops them from releasing chemicals that tell your body to create inflammation.
Bimzelx is prescribed for people with “moderate to severe” Hidradenitis Suppurativa (HS). These patients have abscesses, scarring, or tunnels in their skin as a result of HS.Research shows that Black patients with HS are often diagnosed later than white or Latino patients and are more likely to be given surgery as a treatment option. Bimzelx is intended to treat later stages of the disease and may prevent the need for surgery.
Even though HS is three times more common in Black people than white, research into the condition has mostly been done with non-Blackpatients. The two major clinical trials of Bimzelx were international, and around 11% of the 1,014 participants were Black or African American. In just the U.S. portion of the trial, a little over a third were, which is actually higher than most clinical research in the U.S. However, the research didn’t give specific information on how well the medicine worked for those patients — or whether there are different safety or side effect concerns for Black patients.
That does not mean Bimzelx is not good for Black patients, or that it works differently for us. There are not enough Black patients included in clinical trials for medications in general. Since HS affects our community three times more than others, there is a clear need for more studies and trials with Black participants to help determine why that is and whether medications approved to treat HS work better or worse for Black patients. Likewise, clinical trials that recruit more women are needed, since women make up three-quarters of people living with HS in the US.
Bimzelx is the newest biologic medication approved to treat HS.
Biologics are drugs made using living cells. Other biologics you may have heard of include insulin and clotting factors. The biologics used to treat HS are called monoclonal antibodies, which are proteins made in a lab designed to act like antibodies your body makes naturally. When you have an infection, your antibodies recognize and attach to specific targets, such as germs, and can help your body fight infection. Monoclonal antibodies can be designed to target many different things. For instance, some used to treat cancer help the immune system recognize and attack cancer cells.
The monoclonal antibodies used to treat HS are designed to block specific signals in your immune system that cause inflammation. Bimzelx targets two signaling proteins, interleukin-17A (IL-17A) and interleukin-17F (IL-17F). These proteins normally help your immune system manage inflammation and fight infection, but they are found at higher levels in HS. Bimzelx attaches to these two proteins and stops them from sending inflammatory signals to other cells. Because it targets these two specific proteins Bimzelx is called an IL-17A + IL-17F inhibitor.
Your provider may recommend a monoclonal antibody if other treatments, such as antibiotics, have not worked or are not doing enough to treat your symptoms, or may decide to start with a monoclonal antibody if you already have moderate symptoms. Sometimes providers recommend more than one treatment, for instance if it is clear that your HS is influenced by hormonal changes, they may prescribe a hormonal therapy at the same time as a monoclonal antibody.
Bimzelx is prescribed for adults with “moderate to severe” HS, which usually means that you have abscesses, scarring, or tunnels in your skin.
Bimzelx helps calm down the inflammation that comes with HS. It does this by attaching to two proteins in your body, IL-17A and IL-17F. These proteins are like little messengers that tell your body to create more inflammation and are found at higher levels in HS bumps and lesions. Bimzelx helps calm down the inflammation that comes with HS. It does this by attaching to and blocking proteins in your body called IL-17A and IL-17F. These proteins are like little messengers that tell your body to create more inflammation and are found at higher levels in HS bumps and lesions. Bimzelx stops IL-17A and IL-17F from sending those inflammatory messages. This lowers the inflammation that creates your symptoms.. This lowers the inflammation that creates your symptoms.
Bimzelx is a shot that you can give yourself. It comes in a pre-packaged autoinjector and a prefilled syringe (which you need to store in the refrigerator). Your provider will give you specific instructions and show you how to use the device before you do it on your own at home. For the first 16 weeks, you will inject yourself once every two weeks. After that, you only need to take the shot every four weeks for as long as you are on the medication. If you forget to take your dose, take it as soon as you remember. Make sure to talk about all of this with your provider.
The 1,014 adults with moderate to severe HS who participated in the clinical trials had been dealing with HS for at least six months, and many for much longer. They all had five or more painful lumps (called inflammatory nodules) and/or pus-filled bumps (abscesses). They had also tried antibiotics by mouth, which hadn’t helped enough.
After 16 weeks of treatment, about half of the people who took Bimzelx saw a big improvement: they had 50% fewer abscesses and nodules, and no new ones appeared. In comparison, about one third of the people who did not get the drug saw that much improvement. Many participants who took Bimzelx reduced their number of skin problems by 70% or more.
Almost a year after the study began (48 weeks), participants were still seeing the same results, or had improved more. Those taking Bimzelx also said their pain got better starting as early as two weeks into the study, and kept improving. Many who described their pain as “severe” at the beginning of the study later said it was mild or even completely gone by the end.
Possible side effects include:
Contact your healthcare team immediately if you experience:
Liver enzymes can increase when people are taking Bimzelx. These enzymes are proteins that help your liver do its job of processing nutrients, medications, and other substances. When your liver is stressed or damaged, it will release some of these enzymes into your blood, which is a sign that your liver is struggling. Your doctor will do a simple blood test to check your enzyme levels before you start Bimzelx and then regularly as long as you are taking the medication. For people who have been diagnosed with liver disease or cirrhosis, Bimzelx is probably not a good medication choice. So, make sure your doctor is aware of any liver condition or concern you have.
Bimzelx works by blocking two proteins in your immune system that cause inflammation. But these same proteins also help your body fight off infections. So, taking Bimzelx can make it more likely that you will develop certain infections, especially fungal infections in your mouth, throat, skin, nails, feet or genitals.Your doctor should test you for tuberculosis (TB) before you start Bimzelx. You should not start the medication if you have an active TB or other serious infection.
Talk to your doctor if you tend to get a lot of infections, have any that keep coming back, or if you live with diabetes. Diabetes can make it harder for your body to fight infections. Having diabetes doesn’t automatically mean you cannot take Bimzelx, but your doctor should know before prescribing the medication. If you have diabetes and take Bimzelx, talk with your provider about any special precautions they would like you to take. They will likely ask you to be in touch with them at the first sign of any infection.
Bimzelx isn’t known to have many direct interactions with other medicines. Still, make sure your healthcare provider knows about everything you take, including prescription and over-the-counter medicines, vitamins, and supplements.
Bimzelx may change how quickly your body breaks down certain medicines. This includes warfarin, a blood thinner that needs to stay within a certain level in your body. If you take warfarin, your provider may need to monitor you more closely or adjust your dose when you start or stop Bimzelx.
This may be particularly important for Black patients. Studies have found that Black patients who need blood thinners have historically been less likely than white patients to receive newer blood thinners and more likely to receive warfarin. If you take warfarin, make sure your provider knows before you start or stop Bimzelx.
There are no known side effects of Bimzelx that only affect Black individuals. However, certain health conditions more common in Black Americans should be discussed with your doctor. For example, diabetes can make it harder to fight infections, and Bimzelx can make you more prone to infections. Having diabetes doesn’t mean you can’t take Bimzelx, but your doctor needs to know about it. Also tell your doctor if you take warfarin, a blood thinner that some studies have found is prescribed more often to Black patients than newer blood thinners. Starting or stopping Bimzelx may change how your body processes warfarin, so your doctor may need to monitor you more closely.
Getting specialist care earlier: Black patients with HS tend to wait longer to see a dermatologist and are more likely than white patients to see a surgeon first. Because a dermatologist can help you understand all of your treatment options—including biologics like Bimzelx—seeing one as early as possible can help you get appropriate treatment for your HS.
The research gap: Even though HS is three times more common in the Black community Black patients haven’t been included in enough studies for HS. The two main studies for Bimzelx included 1,014 adults worldwide. About 11% of all participants were Black, and in the US part of the study, over a third were Black (which is higher than most US medical research). However, these studies didn’t give specific details on how well the medicine worked for Black patients, or if there were any special safety concerns or side effects for them. This lack of specific information shows why we need more dedicated research to understand how HS treatments specifically affect Black patients and women (who make up three-quarters of all HS patients in the US).
Black women may experience HS more than any other group. Studies across the country have shown that HS is more common both in Black people and in women. One smaller U.S. study found that HS was about three times as common among Black women as among white women, but there is little large-scale research focused specifically on Black women. Scientists still don’t know exactly how many Black women in the U.S. have HS, why HS is more common in Black people, or why it is more common in women in general, although hormones appear to play a role.
If you’re thinking about taking Bimzelx and are pregnant, breastfeeding, or hoping to get pregnant, tell your doctor. Bimzelx can reach a developing baby through the placenta, especially later in pregnancy. The safety of Bimzelx in pregnant women and lactating women is unclear. If you are pregnant or thinking of becoming pregnant, or if you are breastfeeding, please talk to your doctor about this.
Your symptoms: Before your appointment, write down (or ask a loved one to write down) a few things: how long you have had bumps, abscesses or tunnels, where they tend to pop up, and how often they come back? Since HS symptoms can flare up and then improve before you see the doctor, snap some photos when your symptoms are at their worst and bring them with you to your appointment. If your provider does not suggest HS as a possibility, ask directly: “Could this be hidradenitis suppurativa?” If you feel like your concerns aren’t being heard or your treatment plan isn’t helping, it’s a good idea to get a second opinion from another doctor.
Your past treatments: Let your doctor know what treatments, if any, you’ve tried before and whether they helped or not. Doctors often consider Bimzelx if other treatments haven’t worked well enough or if your symptoms are already serious or affecting your daily life and comfort.
Your Liver Health: Tell your doctor if you’ve ever had liver disease or cirrhosis. Bimzelx can sometimes make liver enzymes go up, which is a sign that your liver is stressed or damaged. If so, your doctor will need to do a blood test to see how your liver is working before you start the medicine and regularly while you’re taking it.
Infections and TB: Because Bimzelx changes how certain proteins in your immune system work, it can also make you more likely to get infections. You can’t take Bimzelx if you have an active TB or other serious infection, so tell your provider about any infections you have or have had.
Living with diabetes: Talk with your doctor if you have diabetes, since that can increase your risk of infection. Having diabetes does not mean you cannot take Bimzelx, but your doctor will probably want you to let them know right away if you develop any infection while taking it.
Your pain level: Research and history shows that pain experienced by Black patients is not understood or treated with the same care by many people in the medical field. Research — and history and real life — show us that , as Black patients’ , our pain is often not taken seriously by the medical community. You deserve relief if pPain is a significant part of living with HS. Be sure to speak up. Talk about your level of pain with your doctor ,– and get specific. Is it making it hard to sleep? Does it stop you from doing work, moving your body, or doing what you need to do? Is it affecting your mood? How often do you notice it? Ask your doctor what you can do or take to manage your pain now. Treatments like Bimzelx can start making a big difference in your pain in as little as two weeks, but you might need some immediate relief until then.
Medication interactions: Before you start Bimzelx, tell your doctor about all the medications you’re taking. This is especially important if you’re on the blood thinner warfarin. When you start or stop Bimzelx, it might change how your body handles some medicines, including warfarin, so your doctor might need to keep a closer eye on how warfarin is affecting you. Research shows that Black patients who need blood thinners have historically been prescribed older blood thinners like warfarin more often than newer ones, compared to white patients. So, if you’re taking warfarin, be sure to tell your doctor before you start Bizmelx.
How to give yourself the shot: Your provider’s office should demonstrate exactly how to use the pre-filled syringe or autoinjector by having you give yourself the first dose in their office, before you do it at home. If a family member will be helping you with the shots, have them come to the appointment with you.
Insurance and cost: Most insurance plans want a pre-approval for these kinds of biologic drugs, and some might even make you try a different medicine first. If you have commercial insurance, UCB, the company that makes Bimzelx, has programs that can help to significantly cut down the cost if you qualify. They can also offer temporary help if your insurance is dragging its feet or says no at first. Though the program does not apply if you have Medicaid or Medicare, the government plans usually cover Bimzelx with smaller co-pays. UCB also has another program, called the Patient Assistance Program, for folks who don’t have insurance, don’t have enough insurance, or are currently having financial struggles that make it impossible to pay.
If you have commercial insurance, UCB, Inc., the maker of Bimzelx, offers programs that can significantly reduce the cost if you qualify. They also offer temporary assistance if your insurance is delayed or initially denies coverage. While the program does not apply to Medicaid or Medicare, these government plans typically cover Bimzelx with smaller co-pays. UCB also offers a Patient Assistance Program for individuals who are uninsured, underinsured, or experiencing serious financial hardship.
Learn more about savings and support about Bimzelx
If your provider recommends Bimzelx, but your insurance denies it or the medication seems too pricey, don’t assume it will not work for you. Talk to your dermatologist about appealing the insurance decision and ask them about all the financial help programs out there.
This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment.
There are no known side effects of Bimzelx that only affect Black individuals. However, certain health conditions more common in Black Americans should be discussed with your doctor. For example, diabetes can make it harder to fight infections, and Bimzelx can make you more prone to infections. Having diabetes doesn't mean you can't take Bimzelx, but your doctor needs to know about it. Also tell your doctor if you take warfarin, a blood thinner that some studies have found is prescribed more often to Black patients than newer blood thinners. Starting or stopping Bimzelx may change how your body processes warfarin, so your doctor may need to monitor you more closely.
Bimzelx often requires insurance approval, and some plans might make you try another treatment first. If your insurance denies coverage, ask your dermatologist about appealing the decision. UCB, the company that makes Bimzelx, also has programs that can help eligible patients with costs. Some programs are for people with commercial insurance, while a separate program may be available for those who are uninsured, underinsured, or facing serious financial hardship.
Black women may experience HS more than any other group, but there isn't much research specifically focused on them. Black patients made up about a third of the U.S. participants in the main Bimzelx HS studies. However, researchers haven't shared enough information to know if Bimzelx works differently or causes different side effects in Black patients, and there is also very little research on HS in women in general. There's limited information about Bimzelx use during pregnancy and breastfeeding, or its effects on fertility. If you're pregnant, breastfeeding, or hoping to become pregnant, talk to your dermatologist and OB/GYN before starting Bimzelx.
Before you start Bimzelx, your doctor will test you for tuberculosis (TB) and do a blood test to check your liver. You shouldn't start Bimzelx if you have active TB or another serious infection. It's also generally not recommended for people with active liver disease or cirrhosis. Be sure to tell your doctor if you get frequent infections or have diabetes. While diabetes doesn't mean you can't take Bimzelx, both diabetes and Bimzelx can increase your risk of infection, so it's important for your doctor to be aware. In addition, avoid taking live vaccines, such as those used to prevent Chickenpox and some flu vaccines, while taking Bimzelx.
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