Atopic dermatitis is a common type of skin condition called eczema. Eczema can cause inflammation and irritation of your skin. Some people may be able to control their symptoms with topical (on-the-skin) creams and ointments, but people with moderate to severe eczema may not benefit from these treatments and may need medicine that is taken by mouth or given as a shot. Ebglyss (lebrikizumab-lbkz) is an injectable medicine that was approved in 2024 to treat patients with moderate to severe eczema. Below you will find common questions and answers about Ebglyss to help you decide whether it's right for you.
How Does Ebgylss Work for Eczema?
Ebglyss is a type of medicine called a monoclonal antibody, and it works by targeting a protein in your body called interleukin-13 (IL-13). When you have eczema, your body may produce too much IL-13, causing inflammation of your skin. Ebglyss stops IL-13 from producing the cytokines that can stimulate your immune system and cause inflammation, thereby reducing symptoms of eczema.
Who Can Get Ebglyss?
Ebgylss treats moderate to severe eczema in adults and children who are at least 12 years old and weigh at least 88 pounds (40 kilograms). It is used in people who cannot use topical medicine to treat their eczema or who have not had success with topical medicine. It may be used alone or along with a topical medicine called a corticosteroid.
How Will I Get Ebglyss?
Ebglyss is a liquid that is put under the skin (subcutaneous injection). You will get Ebglyss as two shots on the first day, followed by another two shots two weeks later. Then you will get one shot every two weeks for another seven doses, or for longer if needed. If you have a good response, you may get a maintenance shot once every four weeks. A health care provider, yourself, or a caregiver may inject Ebglyss into your stomach, thigh, or back of the upper arm. You should not inject into areas where the skin is tender, red, bruised, hard, or affected by eczema. You should also not inject within 2 inches of your navel (belly button). Each injection should be put into a different site.
Ebgylss comes in two dosage forms: a prefilled syringe and a prefilled pen, both with a needle shield. If your health care provider decides that you or a caregiver can inject Ebglyss at home, you will get training on how to properly inject the medicine and your prescription should come with an “Instructions for Use” pamphlet. Both dosage forms are stored in the refrigerator. The prefilled syringe should be left at room temperature for 45 minutes before use. You can ask your health care provider or pharmacist if you have questions about how to inject Ebglyss.
How Was Ebglyss Studied?
Ebglyss was studied in three trials – ADvocate 1, ADvocate 2 and ADhere – in people who had moderate to severe eczema that did not respond to topical treatment for at least one year. The people in these studies were at least 12 years old, had a baseline Eczema Area and Severity Index (EASI) score of at least 16, an Investigator’s Global Assessment (IGA) score of at least 3, and an affected body surface area of at least 10%. An EASI score is calculated based on the area of eczema lesions and how severe they are. A score of 0 means clear or no eczema, 0.1 to 1.0 means almost clear, 1.1 to 7 means the disease is mild, 7.1 to 21 means the disease is moderate, 21.1 to 50 means the disease is severe, and greater than 51 means the disease is very severe. People were not included in these trials if they had gotten Ebglyss before or other medicines similar to Ebgylss.
In ADvocate 1 and ADvocate 2, people received either Ebglyss or a placebo every two weeks. There were 851 people in the two trials, and there were twice as many people in the Ebglyss groups as there were in the placebo groups. The average age for both trials was about 36 years old, and 12% were between the ages of 12 and 17. Males and females were split evenly among the groups. Overall, 63.7% of the people were White, 22.6% were Asian, and 9.9% were Black.
In ADhere, people received Ebglyss plus topical corticosteroid (TCS) therapy or a placebo plus TCS. There were 211 people in this study, and there were twice as many in the Ebglyss group as there were in the placebo group. The average age of patients was 37 years old, and 22% were between the ages of 12 and 17. Males and females were evenly distributed among the groups. In this trial, 61.6 % of people were white, 14.7% were Asian, and 13.3% were Black or African American.
What Benefits Were Seen With Ebglyss?
The primary endpoint for all three trials was the percentage of people who achieved an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and at least a 2-point improvement from baseline at week 16. The trials also looked at improvement in EASI-75 and EASI-90, and improvement in itch severity scores, which was defined as a reduction of at least 4 points on the Pruritus Numerical Rating Score (NRS). The IGA and EASI are tools used for measuring and monitoring eczema by looking at thickening and hardening, redness, and scaling of your skin lesions. EASI also takes into account where the dermatitis is on the body. EASI-75 indicates an improvement of at least 75% in the EASI score; whereas, EASI-90 indicates a 90% improvement. The Pruritus NRS measures how bad your itching is using a scale of 0 (no itch) to 10 (worst itch).
In both ADvocate trials, a significantly larger percentage of people had an IGA response in the Ebglyss group versus those in the placebo group. More people in the Ebglyss group also saw an EASI-75 and EASI-90 response, as well as at least a 4-point reduction in Pruritus NRS than people in the placebo group (see Table 1).
Table 1:
| ADvocate 1 | ADvocate 2 | ||
| Ebglyss | Placebo | Ebglyss | Placebo |
IGA response | 43% | 13% | 33% | 11% |
EASI-75 Response | 59% | 16% | 52% | 18% |
EASI-90 Response | 38% | 9% | 31% | 10% |
Reduction of >/= 4 points in Pruritus NRS | 45.9% | 13% | 39.8% | 11.5% |
In the ADhere trial, there was a greater percentage of people in the Ebgylss plus TCS group who had an IGA response than in the placebo plus TCS group. There were also more people who achieved an EASI-75 or EASI-90 response and had a reduction in their Pruritus NRS score in the Ebglyss plus TCS group (see Table 2).
Table 2:
| ADhere | |
| Ebglyss + TCS | Placebo + TCS |
IGA response | 41.2% | 22.1% |
EASI-75 Response | 69.5% | 42.2% |
EASI-90 Response | 41.2% | 21.7% |
Reduction of >/= 4 points in Pruritus NRS | 50.6% | 31.9% |
What Should I Do Before Starting Treatment?
You should tell your health care provider if you have a helminth (parasitic) infection. If you have a parasitic infection, your health care provider may have you take medicine to treat the infection before starting Ebglyss. If you get a parasitic infection while taking Ebglyss, your health care provider may stop your shots.
Your health care provider will review your vaccination record and recommend any vaccines you may need before starting Ebglyss. You should not get any live vaccines while you are receiving Ebglyss. Live vaccines include measles, mumps, rubella (MMR) and chickenpox.
It is unknown if Ebglyss can harm a fetus or if it will pass into your breast milk. You should tell your health care provider if you are pregnant or plan on becoming pregnant before starting Ebglyss.
How Long Does It Take Ebglyss to Work?
You may see an improvement in your eczema symptoms, such as skin itchiness and redness, in as little as two weeks, but it can take several months to see the full benefit. In clinical studies, most people saw a response in about 16 weeks.
What Are the Possible Side Effects of Ebglyss, and How Can I Prevent or Manage Them?
The most common side effects of Ebglyss are inflammation of eyes and eyelids (conjunctivitis), reactions where the needle went in, and shingles (herpes zoster).
You may have eye and eyelid inflammation, including redness, swelling, and itching, while you are getting Ebglyss shots. There are some things that you can do to ease your symptoms. You can soak a washcloth in cool or warm water and use it as a light compress on your closed eyes. You can do this several times a day. You can also use over-the-counter lubricating eye drops or artificial tears, which may help with itching. Your health care provider may also give you a prescription for steroid eye drops. If you wear contacts, you may need to stop wearing them while your symptoms persist and instead wear your glasses. You should tell your health care provider if you have any symptoms of conjunctivitis.
Ebglyss can irritate the skin where you get the shot. You can help prevent this by making sure you inject into a different site for every shot. Also, avoiding skin that is red, swollen, or sensitive may help prevent this symptom.
Shingles is caused by a chickenpox virus that has been “woken up” (reactivated) after it has been asleep (dormant) in your body for some time. One of the main symptoms of shingles is pain that may feel like burning or tingling, often on one side of your face, chest, back, or waist. This pain may come with a rash, and sometimes, this rash may spread to your nose or around your eye. You may also have flu-like symptoms such as a fever, headache, chills, or fatigue. If you have any of these symptoms, you should contact your health care provider right away. They may be able to give you medicine to help with your pain and other symptoms.
Is There a Cost Savings Program?
A savings program from the drugmaker may make the monthly copay for your Ebglyss prescription as low as $5. Whether you are eligible depends on your insurance coverage. You can find out more by visiting https://ebglyss.lilly.com/savings-support or by calling 800-545-5979.
