By Paras P. Vakharia, MD, PharmD, with Keri Wiginton
Vakharia is assistant professor of dermatology at Northwestern University Feinberg School of Medicine in Chicago. The information here represents his knowledge and experience as a medical professional. Vakharia was not involved in the development of or clinical trials for nemolizumab (Nemluvio).
Prurigo nodularis is a chronic skin condition that causes intensely itchy bumps. These hard lumps, called nodules, often appear on areas you can easily scratch, like your arms, legs, and upper back. The more you scratch, the more bumps form, creating an itch-scratch cycle that can be tough to break.
In August 2024, the FDA approved nemolizumab (Nemluvio) for adults with moderate-to-severe prurigo nodularis. To help explain how this medication works and who might benefit from it, we spoke with Paras Vakharia, a dermatologist at Northwestern Medicine in Chicago with expertise in medical and pharmacy training.
Who is this treatment for?
Clinical trials for nemolizumab have mostly focused on adults with moderate-to-severe prurigo nodularis (PN). To fit this group, you’d typically need to be 18 or older, have 20 or more nodules, and rate your daily itch intensity as a 7 or higher on a scale where 0 means no itch and 10 is the worst itch imaginable.
In general, nemolizumab is worth talking about with your doctor if you have intense itching that hasn’t improved with other treatments. It may be especially helpful if your symptoms disrupt your daily life, affect your mental health, or keep you awake at night.
That said, nemolizumab likely won’t be the first treatment your doctor suggests, especially if you’re newly diagnosed. It’s usually an option after other therapies, like topical steroids or light therapy, haven’t worked.
What’s different about this drug?
Nemolizumab is a monoclonal antibody, a type of biologic medication that targets specific parts of the immune system. It’s the second biologic approved for prurigo nodularis (PN), but it’s the first to directly block a key protein that drives itch.
While the exact cause of PN is not clear, here’s a breakdown of how nemolizumab works:
When your immune system senses a problem – like germs, allergens, or an injury – it sends out chemical messengers called cytokines. These proteins tell your body to protect or heal itself. For example, an itch is your brain’s way of telling you to scratch something bothering your skin.
Normally, this kind of short-term inflammation is helpful, but people with PN tend to have chronically high levels of IL-31. And we know IL-31 plays a big role in triggering feelings of itchiness. Nemolizumab blocks IL-31, reducing the number of itch signals sent to your brain. This helps break that frustrating itch-scratch cycle and gives your skin a chance to heal.
Other treatments, like steroids you rub on your skin or phototherapy, mainly focus on calming overall inflammation and soothing your skin. While they can ease symptoms of PN, they don’t directly address the itch itself.
The first biologic approved to treat prurigo nodularis, dupilumab (Dupixent), works by blocking other proteins that are broadly involved in inflammation and itch (IL-4 and IL-13). But nemolizumab targets IL-31, which is thought to be mostly an “itch cytokine.”
How effective is this treatment? How fast does it work?
There’s no way to know exactly who’ll respond to nemolizumab or how quickly it will work, but I usually tell people to expect noticeable relief within a month. Some people probably feel better sooner.
In recent clinical trials, about 4 out of 10 (41%) people taking nemolizumab reported significantly less itching after just four weeks. By week 16, that number increased to almost 6 out of 10 (56.3%). At least half of study participants also reported better sleep and fewer nodules by the end of the 16-week trial, and many ended up with clear or almost clear skin.
I’ve seen similar results in my patients. Most tell me they feel more comfortable and can finally sleep through the night again within a month or two. That’s a big deal when you’ve been dealing with unrelenting itchiness for so long. They also appreciate having an effective treatment after years of limited options.
How do you take nemolizumab?
It’s a once-monthly shot you give yourself under the skin. Your doctor or pharmacist will likely give you the first dose and teach you how to do it at home. It’s pretty simple, and most of my patients find it easy to learn.
You can always ask a health care professional to give you your shot if that makes you more comfortable.
Are there any side effects? How do you manage them?
All medications come with risks, but most people tolerate nemolizumab well. Common side effects include headache and mild pain or redness where the needle goes into your skin. If you have atopic dermatitis (eczema) or asthma, you could have a worsening of symptoms.
Less often, you might get swelling (edema) in your face, legs, or arms or have an allergic reaction. Call your doctor right away if you have trouble breathing or have serious swelling. Mild issues can often be managed with other treatments, but in rare cases, you might need to stop nemolizumab.
Since nemolizumab is a biologic, it can weaken parts of your immune system. This might make you more likely to get certain infections, like colds or other respiratory illnesses. Your doctor should talk to you about the best ways to keep a check on these risks and what to do if you get sick.
Is this treatment safe?
Yes, nemolizumab has been shown to be safe and well-tolerated. You can take it even if you have conditions like liver or kidney disease. If you have eczema or asthma, though, it’s important to discuss this with your doctor. While you may see improvements in these conditions, it’s possible to have a flare-up.
How long do you take it? Is it safe to use with other treatments?
Nemolizumab is intended for long-term use. While you might not need to take it forever, you should expect to use it for an extended period unless you and your doctor find a more effective way to manage your symptoms. Again, it’s not a short-term or as-needed treatment.
This drug is meant to be used on its own, but you can still use topical medication to help with a few spots here and there if you need to. And I always recommend lifestyle changes, things like keeping your nails trimmed, moisturizing often, and trying to scratch less (which I know is easier said than done!).
How often will you need follow-ups?
When I start people on nemolizumab, I suggest follow-ups at least every two months to monitor how they’re doing and check for any side effects. Once we’re confident the treatment is working for them, those visits can be spaced out every few months.
Will insurance cover it?
Since nemolizumab is new, your insurance might ask you to try other treatments first. But most people with moderate-to-severe PN have already tried older treatments without success, so getting insurance approval hasn’t been a problem in my experience.
Once approved, you may not get your medication right away. There’s often a delay while a specialty pharmacy fills your prescription and ships it to your home. That process can take a few weeks.
If cost is a concern, the drugmaker offers financial help through the Galderma Patient Services program. You can visit their website or call 855-NEMLUVIO to learn more.
How can you find out if nemolizumab is right for you?
Start by making an appointment with your dermatologist. If you feel like your doctor doesn’t know much about nemolizumab or prurigo nodularis, ask if they can refer you to a specialist in medical dermatology or itch disorders – academic centers often have clinics that focus on these issues.
Before your visit, write down how your symptoms affect your life – like how it messes with your sleep, mental health, social life, work, or daily activities. This can help you remember what to talk about and make sure your doctor understands what you’re going through.
How carefully was this drug studied?
The FDA approved nemolizumab after seeing good results from the OLYMPIA trials, which tested the drug’s safety and effectiveness in over 500 people with prurigo nodularis. But researchers have actually been studying this drug for years, including looking at how it might help with other skin conditions like atopic dermatitis.
Nemolizumab’s approval is a big step forward, but scientists are still working on finding new therapies. With growing interest in itch disorders, the future of treatment looks promising for people with prurigo nodularis.
I think we’re just scratching the surface with biologics – there are many more on the way. And these therapies are exciting because they don’t suppress your entire immune system and target the actual source of the itching, not just the symptoms.
It’s incredibly gratifying to see these drugs move from research labs to real life. Because if you’re someone who’s struggled with limited treatment options for prurigo nodularis, you know just how life-changing it can be to find a medication that really works.
