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EBGLYSS STUDY FOR

PEOPLE WITH DIVERSE SKIN TONES

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In a study for people with diverse skin tones

EBGLYSS helped provide clearer skin from moderate-to-severe eczema for a variety of skin tones

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Data collected in a less rigorous study so findings are less certain.

Select Safety information

Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS.

See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.

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Skin improvement across a variety of skin tones

In a first-of-its-kind EBGLYSS study, designed to focus on moderate-to-severe eczema in diverse skin tones, 89% saw noticeably clearer skin at week 16

Data collected in a less rigorous study so findings are less certain. This analysis was not the main purpose of the study.

“Noticeably clearer” skin is at least 50% clearer skin.

Study design

The efficacy and safety of EBGLYSS were evaluated in a 24-week study in adults and teens aged 12 and older who weighed ≥88 pounds with skin of color who had moderate-to-severe eczema.

The main goal of the study was to measure the number of people with moderate-to-severe eczema who saw at least 75% clearer skin at 16 weeks. The study consisted of 90 adults and teens (aged 12 and older) with a self-reported race other than White and whose skin rarely or never burns and tans easily.

People studied were able to apply topical therapies as needed.

The study of EBGLYSS for people with skin of color was a less rigorous study, and both doctors and patients were aware of the treatment being studied.

The safety of EBGLYSS in a study specific to people with diverse skin tones was similar to other EBGLYSS studies of people with moderate-to-severe eczema.

See the most common side effects from EBGLYSS clinical trials and other safety information.

SAFETY SUMMARY

Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.

Before using
Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you:

  • Have a parasitic (helminth) infection.
  • Are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with EBGLYSS.
  • Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.
  • Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Possible side effects
EBGLYSS can cause serious side effects, including:

  • Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
    • breathing problems or wheezing
    • swelling of the face, lips, mouth, tongue or throat
    • hives
    • itching
    • fainting, dizziness, feeling lightheaded
    • skin rash
    • cramps in your stomach area (abdomen)
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.

The most common side effects of EBGLYSS include:

  • eye and eyelid inflammation, including redness, swelling, and itching
  • injection site reactions
  • shingles (herpes zoster)

These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How to take

  • See the detailed “Instructions for Use” that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes.
  • Use EBGLYSS exactly as prescribed by your healthcare provider.
  • EBGLYSS is given as an injection under the skin (subcutaneous injection).
  • If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver.
  • If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time.

Learn more
EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com

This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you.

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INDICATION

EBGLYSS (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids.

It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg).