FAQ – Nemluvio® (Nemolizumab-ilto)

What is Nemluvio?

Nemluvio (nemolizumab-ilto) is a biologic drug approved by the FDA for people ages 12 and older with moderate to severe atopic dermatitis, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI), whose disease is not adequately controlled with topical prescription therapies.  

Moderate to severe atopic dermatitis is generally determined by skin involvement (how much of your body surface is affected) and severity of symptoms, such as itch and rash that cannot be controlled by topical medications alone. However, atopic dermatitis can be considered moderate or severe if the disease has a significant negative impact on your quality of life, even if the body surface affected is more limited. It’s important to talk to your doctor about how atopic dermatitis affects not just your skin but also other aspects of your life. 

Together, you and your healthcare provider can determine if Nemluvio is an appropriate treatment option.  

What type of medicine is Nemluvio?

Nemluvio is a biologic, a type of medicine made from living organisms or components from living organisms (like proteins).  

Biologics are designed to target specific parts of the immune system that contribute to chronic inflammatory diseases, such as atopic dermatitis. Biologics take an “inside out” approach to treating inflammatory conditions. 

How does Nemluvio work?

Nemluvio works by inhibiting the activity of a protein called interleukin-31 (IL-31). Nemluvio is an antibody that specifically targets the IL-31 receptor alpha (IL-31R alpha) on the surface of cells, preventing IL-31 from binding and initiating its effects. IL-31 can be produced by many cells of the immune system and has been found to contribute to the itch, inflammatory processes and decreased barrier functions in atopic dermatitis.  

How do you take Nemluvio?

Nemluvio is taken by subcutaneous injection (an injection under the skin). Nemluvio is not available as a pill or a cream.  

Like other biologics for atopic dermatitis, Nemluvio is an antibody with a unique protein structure, and must be given by injection. If given in a pill, our digestive system would break down the structure needed for Nemluvio to bind to its target, making the drug ineffective.

The recommended dosage of Nemluvio is an initial 60 mg dose (given as two 30 mg injections), followed by a single 30 mg injection every 4 weeks.1  

After 16 weeks of treatment, for patients who achieve clear or almost clear skin, a dosage of 30 mg every 8 weeks is recommended.1 

How effective is Nemluvio for atopic dermatitis? 

In the ARCADIA 1 and 2 clinical trials for Nemluvio (Nemluvio or placebo in combination with TCS and/or TCI), after 16 weeks on Nemluvio2:

  • Primary Clinical Trial Endpoints:
    • Investigator Global Assessment (IGA)
      • A tool used to provide a clinical trial investigator rating of overall disease severity at a particular time point. 
      • 36% and 38% of patients had an IGA score of clear to almost clear (IGA 0 or 1) versus 25% and 26% on placebo.   
    • Eczema Area and Severity Index (EASI)-75
      • An investigator tool used to measure the extent (area) and severity of atopic dermatitis. EASI-75 is a 75% improvement in this score from the start of the trial.
      • 44% and 42% of patients achieved an EASI-75 versus 29% and 24% on placebo.  
  • Reductions in itch (decreases equal or greater to 4 points on the itch numeric rating scale) were also observed with Nemluvio vs placebo with statistically significant reduction after 1 week.
    • 1 week itch reduction: 5% and 7% versus 1% and less than 1% on placebo
    • 16 week itch reduction: 43% and 48% versus 18% and 21% on placebo

Clinical trial long-term extension data (56 weeks) has not yet been published, however interim results suggest continued efficacy and safety of Nemluvio.3 

What are the most common side effects of Nemluvio?

In clinical trials, the most common side effects reported in ≥1% of those taking Nemluvio (and greater than the recorded rate in placebo group) were headache, arthralgia (joint pain), urticaria (hives) and myalgia (muscle aches). The majority of side effects were mild to moderate in severity.1,2

Are there other biologics FDA-approved for atopic dermatitis?

Yes. Adbry (tralokinumab-ldrm), Dupixent (dupilumab) and Ebglyss (lebrikizumab-lbkz) are all biologics that are FDA-approved for moderate to severe atopic dermatitis. Each has a different antibody target. Learn more about these other biologics here. 

Clinical trials for other biologics for atopic dermatitis are currently underway.

Head-to-head comparative clinical trials of Nemluvio to other biologics are not yet available.  

How long do I have to take Nemluvio?

Atopic dermatitis is a chronic skin disease that can affect everyone differently. The length of therapy with Nemluvio should be discussed with your healthcare provider.  

Can children use Nemluvio?

Nemluvio is approved by the FDA for adolescents ages 12 and older. Nemluvio is not FDA-approved for children ages 11 years and younger, although clinical trials are underway.4  

Can I use Nemluvio with other prescription atopic dermatitis therapies?

Talk to your healthcare provider about using Nemluvio with other prescription and over-the-counter therapies for atopic dermatitis. Nemluvio can be used in combination with topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI).1 

Be sure your doctor knows all medications you are using for your atopic dermatitis as well as other medical conditions.  

How much does Nemluvio cost?

The cost for Nemluvio depends on your health insurance coverage for prescriptions. Galderma, the company that makes Nemluvio has a program to help with your copay costs and other care issues if needed. You can learn more and complete the online enrollment for the GPS (Galderma Patient Services) program here or call 1.855.NEMLUVIO from 8 a.m. – 8 p.m. ET, Monday-Friday.

How do I know if Nemluvio is right for me?

It’s important to talk to your doctor about how atopic dermatitis affects your skin and other aspects of your life. Together, you and your healthcare provider can determine if Nemluvio is an appropriate treatment option.  

How can I get Nemluvio?

Nemluvio is available by prescription only. Talk to your healthcare provider and visit www.Nemluvio.com to learn more.

________________

1Prescribing information. https://www.nemluvio.com.  

2Silverberg JI, Wollenberg A, Reich A et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024;3;404(10451):445-460.

3EADV 2024 Late breaking news sessions: new Galderma data demonstrating nemolizumab’s long-term efficacy and safety in atopic dermatitis and durability in prurigo nodularis to be shared during three oral presentations. September 25, 2024. https://www.galderma.com/news/eadv-2024-late-breaking-news-sessions-new-galderma-data-demonstrating-nemolizumabs-long-term

4Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis. https://clinicaltrials.gov/study/NCT04921345

Get the latest eczema news delivered to your inbox.