What Is It, and Why Does It Matter?
Ebglyss (lebrikizumab-lbkz) is a prescription biologic medicine given as an under-the-skin (subcutaneous) injection to treat moderate to severe atopic dermatitis, or eczema. It is approved in adults and children ages 12 years and older who weigh at least 40 kilograms (88 pounds) if prescription creams or ointments do not work or aren't advisable. Ebglyss can be used alone or with topical corticosteroids, depending on the treatment plan recommended by your health care provider.
The FDA approved a less frequent maintenance dosing plan of every eight weeks for Ebglyss. Once patients achieve an adequate clinical response after the initial treatment period, they transition to a maintenance dosing schedule of one injection every eight weeks, or the previously approved once-every-four-week maintenance plan.
People with moderate to severe eczema often have repeated flare-ups and demanding treatment routines. This approval matters as a once-every-eight-week shot offers reliable disease control with fewer injections to eligible patients.
Ebglyss is a lab-made antibody that selectively targets interleukin-13 (IL-13), a protein that sends signals that cause inflammation, a key factor in the development of eczema. Ebglyss binds to IL-13 to block its signal, calming inflamed skin, easing symptoms, and allowing the body to naturally clear IL-13, which provides consistent disease control and fewer flare-ups.
Why Was It Approved?
The FDA's approval was based on analyses that tracked how drug levels in the body over time related to symptom control (exposure-response modeling). The results showed that Ebglyss maintained similar skin clearance whether given as a single shot every eight weeks or every four weeks. Also, patients who responded to treatment could safely keep their condition under control using a once-every-eight-week maintenance dose instead of the more frequent once-monthly dose.
An extension study lasting 32 weeks was done to assess longer-term safety and benefits in adults and adolescents (ages 12-17 years and weighing ≥ 40 kilograms) with moderate to severe eczema receiving Ebglyss either once every eight weeks or once every four weeks. Results showed that 79% of patients on the once-every-eight-week plan versus 86% of patients on once-monthly dosing achieved or maintained an improvement of at least 75% in the Eczema Area and Severity Index. Also, 62% and 73% of patients, respectively, achieved or maintained clear or almost-clear skin. No new safety concerns or immune system issues (immunogenicity) were observed with the extended dosing interval.
The most common side effects were eye inflammation (conjunctivitis), reactions where the needle went in, and shingles (herpes zoster).
What Do I Need to Know?
Ebglyss comes as a single-dose prefilled pen or syringe and is given as a shot under the skin. Your health care provider will train you or a caregiver on how to safely inject it. The dosing plan starts with two loading doses, followed by shots every two weeks until week 16 or until a good response is seen. After that, based on your or your child's response and your health care provider's plan, you or your child will receive a maintenance dose either once every four weeks or once every eight weeks. For adolescents, a trained caregiver may give the shots. If you miss a dose, take it as soon as you can, then return to your regular schedule.
Before starting Ebglyss, let your health care provider know about your or your child's medical conditions, including any parasitic (helminth) infections. Also tell your health care provider about all medicines – including prescription and over-the-counter medicines, vitamins, and herbal supplements – you or your child takes and about your or your child's vaccination schedule. It is advisable to get all recommended vaccines before you or your child starts Ebglyss and to avoid live vaccines during the treatment.
Do not use Ebglyss if you or your child has had a serious allergy to lebrikizumab-lbkz or to any of its ingredients.
Discuss with your health care provider if you are pregnant, planning to get pregnant, or breastfeeding, as it is not yet known whether Ebglyss can harm a fetus or whether it passes into breast milk.
Call your health care provider right away if you or your child has new or worsening eye symptoms, such as pain or changes in vision, or any signs or symptoms of allergic reactions, such as breathing problems; swelling of the face, lips, mouth, tongue, or throat; hives; itching; a skin rash; fainting; dizziness; feeling lightheaded; or cramps in your stomach area (abdomen).