FAQ – EBGLYSS™ (Lebrikizumab-lbkz)

What is Ebglyss?

Ebglyss (lebrikizumab-lbkz) is a biologic drug approved by the FDA for people ages 12 and older (who weigh at least 88 pounds) with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies used on the skin.  

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 Ebglyss is an appropriate treatment option.  

What type of medicine is Ebglyss?

Ebglyss 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 Ebglyss work?

Ebglyss works by inhibiting a type of protein called interleukin-13, or IL-13, from binding to one of its cell surface receptors (IL-13R alpha 1). IL-13 can be produced by many cells of the immune system and has been found to contribute to the inflammatory processes and decreased barrier functions in atopic dermatitis.  

How do you take Ebglyss?

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

Like other biologics for AD, Ebglyss 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 Ebglyss to bind to its target, making the drug ineffective.

The recommended dosage of Ebglyss is an initial 500 mg dose (given as two 250mg injections at Week 0 and 2) followed by a single 250mg injection every 2 weeks until week 16 or until adequate clinical response is achieved. Maintenance dosing is then a single 250mg injection every 4 weeks.

How effective is Ebglyss for atopic dermatitis? 

In the ADvocate 1 and 2 monotherapy clinical trials for Ebglyss (i.e. Ebglyss used as a single therapy taken every other week), after 16 weeks on Ebglyss1:

  • 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. 
      • 43.1 and 33.2% of patients had an IGA score of clear to almost clear (IGA 0 or 1) versus 12.7 and 10.8% 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.
      • 58.8 and 52.1% of patients achieved an EASI-75 versus 18.1% and 16.2% on placebo.  
  • Reductions in itch (decreases equal or greater to 4 points on the itch numeric rating scale) and improved sleep (decreases equal or greater than 2 points on the sleep-loss scale) were also observed with Ebglyss vs placebo with statistically significant reduction as early as 2 weeks.2
  • Over 70% of patients who saw benefit from Ebglyss at 16 weeks (IGA 0  or 1) maintained their response at 52 weeks with continued bi-weekly or once-monthly Ebglyss dosing.3  

What are the most common side effects of Ebglyss?

In clinical trials, the most common side effects reported were eye and eyelid inflammation (redness, swelling and itching), herpesvirus infections, and injection site reactions. The majority of side effects were mild to moderate in severity.1,3

Are there other biologics FDA-approved for atopic dermatitis?

Yes. Adbry (tralokinumab-ldrm), Dupixent (dupilumab), and Ebglyss are all biologics FDA-approved for moderate to severe atopic dermatitis. Each has a different antibody target. Learn more about Adbry here and Dupixent here. Clinical trials for other biologics for AD are currently underway.

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

How long do I have to take Ebglyss?

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

Can children use Ebglyss?

Ebglyss is approved by the FDA for adolescents ages 12 and older who weigh at least 88 pounds. Ebglyss is not FDA-approved for children ages 11 years and younger, although clinical trials are underway.4,5  

Can I use Ebglyss with other prescription atopic dermatitis therapies?

Talk to your health care provider about using Ebglyss with other prescription and over the counter therapies for atopic dermatitis. Ebglyss can be used in combination with topical corticosteroids (TCS).6 

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

How much does Ebglyss cost?

The cost for Ebglyss depends on your health insurance coverage for prescriptions. Eli Lilly & Company, the company that makes Ebglyss may introduce programs that may help with your copay costs if needed. You can learn more at www.ebglyss.lilly.com. 

How do I know if Ebglyss 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 tralokinumab is an appropriate treatment option.  

How can I get Ebglyss?

Ebglyss will be available by prescription in the coming weeks. Talk to your health care provider and visit www.ebglyss.lilly.com to learn more.

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1Silverberg JI, Guttman-Yassky E, Thaci D et al. Two phase 3 trials of lebrikizumab for moderate-to-severe atopic dermatitis. NEJM. 2023;388(12):1080-191.

2Simpson EL, Fernandez-Penas P, Bruin-Weller et al. Improvement across dimensions of disease with lebrikizumab use in atopic dermatitis: two phase 3, randomized, double-blind, placebo-controlled monotherapy trials (ADvocate 1 and ADvocate2). Adv Ther. Online ahead of print. https://doi.org/10.1007/s12325-024-02974-y

3Blauvelt A, Thyssen JP, Guttman-Yassky E et al. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: 52 week results of two randomized double-blinded placebo-controlled phase III trials. Br J Dermatol. 2023;188:740-748. 

4A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-1). https://clinicaltrials.gov/study/NCT05559359

5A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis (ADorable-2). https://clinicaltrials.gov/study/NCT05735483

6Simpson EL, Gooderham M, Wollenberg A et al. Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adolescents and Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial (ADhere). JAMA Dermatol. 2023 Feb 1;159(2):182-191. 

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