FDA Approves Lebrikizumab-lbkz for Moderate-to-Severe Atopic Dermatitis
Lebrikizumab-lbks is a targeted treatment that addresses the root cause of atopic dermatitis; by reducing inflammation throughout the body, it can help alleviate the dry, itchy, and irritated skin that often characterizes the condition.
The FDA has approved Eli Lilly and Company’s lebrikizumab-lbkz (Ebglyss), a targeted IL-13 inhibitor for the treatment of moderate-to-severe atopic dermatitis that is not well controlled by topical prescription therapies in adults and children 12 years of age and older who weigh at least 88 pounds, the company announced in a release.1
Atopc dermatitis on wrist / ltyuan - stock.adobe.com
Lebrikizumab-lbks injection can be used with or without topical corticosteroids. After an intial treatment phase, it is dosed as a single monthly maintenance injection.
The recommended starting dose is 500 mg, administered as two 250 mg injections at week 0 and 2, followed by 250 mg injections every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is administered as a single 250 mg monthly injection every 4 weeks.
“Patients will struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives,” said Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington DC, and first author of the New England Journal of Medicine manuscript summarizing lebrikizumab-lbks clinical trials, in the release.1 “Today’s FDA approval of Ebglyss is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren’t enough."
READ MORE: Chronic Hand Eczema Studies Show Condition is Common, Burdensome
The approval was supported by data from 3 clinical trials: ADvocate 1 (NCT04146363), ADvocate 2 (NCT04178967), and ADhere (NCT04146363). These studies involved over 1000 adults and children aged 12 years and older with moderate-to-severe eczema that did not improve with topical prescription treatments.
ADvocate 1 and ADvocate 2 were 52-week, randomized, double-blind, placebo-controlled, parallel-group, global phase 3 studies that compared lebrikizumab-lbkz to placebo. ADhere was a 16-week, randomized, double-blind, placebo-controlled, parallel-group, global, phase 3 study to evaluate the efficacy and safety of lebrikizumab-lbkz in combination with topical corticosteroids.
The primary endpoint for all 3 studies measured clear or almost clear skin and was evaluated at 16 weeks.
In the average results of ADvocate 1 and 2, 38% of people who took lebrikizumab-lbks had clear or almost skin after 16 weeks compared to 12% of those who took placebo. For 10% of participants who took lebrikizumab-lbks, this improvement started as early as 4 weeks.
Of those who had clear or almost clear skin at 16 weeks, 77% maintained these results at 1 year with once-monthly dosing. Even when participants were switched form lebrikizumab-lbks to placebo at week 16, 48% maintained clear or almost clear skin a year later.
In both studies, an average of 43% of participants who took lebrikizumab-lbks felt itch relief at 16 weeks compared to 12% of those who took placebo. For 5% of people, itch relief started as early as 2 weeks.
Of those who felt itch relief at week 15, 85% continued to feel relief at 1 year of treatment with once-monthly maintenance dosing. Even when participants were switched from lebrikizumab-lbks to placebo at week 16, 66% felt itch relief a year later.
“Eczema can affect people of all skin tones, ethnicities, genders and ages. Nearly 16.5 million adults in the US have eczema, with 6.6 million experiencing moderate-to-severe symptoms like itchiness, dry and scaly skin, discoloration and rashes, which can lead to more scratching that may cause skin to crack and bleed,” said Kristin Belleson, president and CEO of the National Eczema Association, in the same release.1 “The approval of Ebglyss provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms.”
Severe, uncontrolled atopic dermatitis can significantly disrupt daily life, as those with the chronic skin condition may face challenges in school, work, and personal relationships.2 What’s more, the constant itch and discomfort can lead to sleep disturbances and increased stress, and the visible signs of eczema can lead to feelings of embarrassment, shame, and low self-esteem.3
Lebrikizumab-lbks is a targeted treatment that addresses the root cause of atopic dermatitis; by reducing inflammation throughout the body, it can help alleviate the dry, itchy, and irritated skin that often characterizes the condition.
According to Lilly, lebrikizumab-lbks will be available in the US in the coming weeks.1 The company will offer a patient support program including co-pay assistance for eligible, commercially insured patients, to expand access to the medication.
READ MORE: Dermatology Resource Center
Are you ready to elevate your pharmacy practice? Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.
