I f you’re unhappy with your treatment plan for hidradenitis suppurativa (HS), you may be wondering what’s next for you.
Currently only one medication, a biologic called adalimumab (Humira?), has been approved by the U.S. Food and Drug Administration (FDA) to treat HS. But this drug class isn’t new: Biologics have been used to treat other inflammatory conditions, such as rheumatoid arthritis and psoriasis, for decades.
But biologics can still feel new to many people with HS who are considering them for the first time. You may have questions about how they work and whether or not they’re right for you. We’re here to help.
How Biologics Work for HS
Understanding HS: An Underrecognized Yet Prevalent Skin Disease
HS is a chronic inflammatory skin disease that causes recurrent, painful boil-like lumps to form under the skin, typically in areas where the skin folds or rubs together, such as your armpits, buttocks, breasts, groin, and inner thighs. Over time, these lumps may break open, draining fluid and pus and creating large, open wounds. As these wounds heal, they often turn into scars and may even develop into tunnellike tracts beneath the skin’s surface.
The exact cause of HS isn’t known, but an overactive immune system may play a role. HS occurs when hair follicles become blocked with bacteria, which can cause an immune system response that leads to inflammation, swelling, and redness.
“It’s a severe and debilitating chronic inflammatory skin disease,” explains?Haley Naik, MD, an assistant professor of dermatology and the director of the HS program at the University of California, San Francisco.
Previously thought to be a rare disease, HS actually affects about 1 percent of the population. “That’s the same prevalence as psoriasis, but in comparison to psoriasis, HS is understudied, undertreated, and underrecognized,” adds Dr. Naik. “And it’s often misdiagnosed.”
In fact, it often takes around 7 years to receive an accurate HS diagnosis. While you may feel embarrassed to talk about these symptoms with your doctor, it’s important to speak up and get proper care.
How Biologics Are Transforming HS Treatment
Until recently, there were no FDA-approved medications to treat HS. Then, in 2015, the FDA approved a biologic drug called adalimumab (Humira?) specifically for the treatment of HS. This drug, along with other biologics, already have long track records treating other chronic inflammatory autoimmune conditions, such as rheumatoid arthritis, psoriasis, and ulcerative colitis, but adding HS to the indication list was groundbreaking for the treatment of this skin disease.
That said, many other types of treatment have been and continue to be used to control skin lesions and reduce the discomfort of HS, including nonsteroidal anti-inflammatory medications (NSAIDs), antibiotics, corticosteroids, retinoids, and surgery to drain or remove abscesses.
But biologics work differently: They block the underlying inflammatory process before it even starts.
“Over the last 20 to 25 years, biologics have really become one of the best ways to target the immune system to improve disease states and also to minimize complications of oversuppressing your immune system,” says Iltefat Hamzavi, MD, FAAD, president of the Hidradenitis Suppurativa Foundation and a practicing physician at Hamzavi Dermatology Specialists and Henry Ford Hospital in Michigan.
While adalimumab is the only biologic approved by the FDA for treating HS, others are also used sometimes to treat the condition. Each type of biologic targets a specific protein that’s thought to play a role in triggering the inflammation that contributes to HS.
7 Essential Facts About Biologics for HS
1. There’s only one FDA-approved biologic for HS.
A biologic called adalimumab (Humira?) is the first and only drug approved by the FDA to treat HS. Adalimumab is a TNF-alpha inhibitor, meaning it blocks the signaling pathway of TNF-alpha, a protein involved in the inflammatory process that contributes to HS symptoms. “That said, there are a number of medications and a number of biologics that are used to treat HS off label,” says Naik.
2. Biologic drugs are typically prescribed for moderate to severe HS.
Your treatment options will depend on the severity of your HS, which is divided into three stages, called Hurley stages:
- Stage I: You have one or a few lumps in one area of your body.
- Stage II: Lumps get bigger and may appear in more than one area of your body. You may experience some scarring or tunneling.
- Stage III: You have widespread lumps, with extensive scarring or tunneling, and chronic pain.
Stage I (mild) HS may be managed with warm compresses, antibacterial or antiseptic washes, or NSAIDs. For stages II and III (moderate and severe) HS, your doctor may prescribe antibiotics, corticosteroids, retinoids, hormone therapy, or biologics. “When you have a lot of new nodules and have tried other treatments, that’s when you should consider a biologic,” says Dr. Hamzavi.
3. Biologics are administered by injection or infusion.
Adalimumab, the FDA-approved biologic for HS, is administered through a self-injection at home. Other types of biologics may be administered as an infusion at a hospital or clinic. “Different options are given at different intervals — weekly, monthly, once every three months, or even every day,” says Maria Aleshin, MD, a clinical assistant professor of dermatology and the director of the HS clinic at Stanford Medicine in California.
4. Most people can expect to experience improvement in three months.
You may start to notice some improvement in your HS symptoms after three months. “But we really want to stick it out to about the six-month mark to make sure we understand the maximum benefits that you’re able to get from this medication,” explains Naik.
Because biologics can take some time to start kicking in, “Some dermatologists will prescribe additional therapy, like an antibiotic, to help bridge the gap until the biologic starts working,” adds Dr. Aleshin.
5. Biologics are an effective HS treatment, but they may not work for everyone.
Biologics are a pioneer when it comes to treatment for HS. “This is a disease for which really no good treatments existed for many decades,” says Naik. “Biologics have completely changed the way we treat HS and are more effective than any previous treatment we’ve used to treat this disease.”
But they don’t work for everyone. “For some, a biologic can be incredibly effective. For others, it can be partially effective,” adds Naik. “The main takeaway is that it’s hard to predict how you’re going to respond to biologics unless you try them.”
6. Biologics are considered safe but come with potential side effects.
Each type of biologic has its own unique set of risks and side effects. The most common are pain and redness at the injection site. Because biologics work by suppressing the immune system, they may increase your risk of bacterial and fungal infections as well as certain cancers. And biologics may reactivate latent tuberculosis or hepatitis B or C infections, so you will need to be tested for these conditions before starting a biologic.
That said, two large, randomized control trials, known as Pioneer I and Pioneer II, compared the FDA-approved biologic adalimumab with a placebo, and results showed that adalimumab was very well tolerated and didn’t have significant adverse side effects. These trials were sponsored by AbbVie, the drug company that manufactures adalimumab.
7. They’re expensive, but you have options for coverage and financial assistance.
Biologics can cost $10,000 to $30,000 a year — and potentially in excess of $500,000 a year for the most expensive options. The good news: Now that adalimumab has been approved by the FDA, it’s usually covered by insurance, explains Aleshin. “For some of the other biologics that aren’t approved, we oftentimes have to write a prior authorization letter to insurance companies, advocating on behalf of the patient to explain why the medication is necessary and important,” she says.
You may still have out-of-pocket costs, but how much you’ll need to pay depends on your insurance plan. If you have trouble getting insurance approval or are concerned about paying for your biologic treatment for HS, talk to your doctor, who can help you find a solution that meets your insurance and treatment needs. They can also discuss your financial assistance options, such as patient assistance programs that various pharmaceutical companies offer to help lower the cost of medication.
Is It Time to Try a Biologic for HS?
Your dermatologist will likely recommend trying other treatment options before starting you on a biologic. These may include:
- Topical or systemic antibiotics, which can help infected lesions. “These are considered to be first-line therapy for HS,” explains Naik.
- Topical cleansing products, combined with warm baths or compresses and good hygiene
- NSAIDs, which can help alleviate pain
- Hormone therapy, to address the possibility that HS may be caused by a hormonal imbalance
- Corticosteroids, which can help reduce inflammation and relieve symptoms
- Retinoids, or acne medications, to clear up the skin
“Currently, biologics are intended for people who have more moderate to severe HS that has not been responsive to first-line treatment,” explains Naik.
If you’re having trouble controlling your HS, talk to your dermatologist. Together, you can come up with the right treatment — or combination of treatments — that can help. “It’s important to have a good relationship with a dermatologist who knows about you and your overall health in order to help you make good decisions about biologic treatment,” says Naik.
Our Experts Answer Common Questions About Biologics for HS
Next Steps: Making HS Treatment Decisions
You’ve learned a lot about biologics for HS. So what’s next?
Take some time to absorb all of this info and decide if biologics are something you might want to consider.
Before your next appointment, think about your current treatment plan and how well it’s controlling your HS.
- Are you satisfied with your current treatment?
- Has it improved your HS symptoms as well as you had hoped?
- Does HS impact your emotional health and quality of life?
- Are you downplaying your HS symptoms when you talk to your dermatologist?
- Have you tried other treatments to see if they help you manage your HS?
If you decide it’s time to discuss a potential treatment change with your doctor, jot down some questions you’d like to ask. Here are a few conversation starters you can save on your phone and bring to your next appointment.
- Do you think it’s possible for me to gain better control of my HS?
- What can I do to improve my skin and manage my pain?
- Am I a good candidate for biologic therapy?
- If so, what type of results should I expect?
- How long should I use this medication before I notice any progress?