FDA Approves Lebrikizumab for Treatment of Atopic Dermatitis

Lebrikizumab (Ebglyss; Eli and Lilly Company) received FDA approval for the treatment of adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe atopic dermatitis (AD) that is not well controlled despite treatment with topical prescription therapies. The decision is based on data from the ADvocate 1 (NCT04146363), ADvocate 2 (NCT04178967), and ADhere (NCT04250337) trials, which demonstrated significant itch relief and skin clearance in as early as 2 and 4 weeks, respectively. The approval expands therapeutic options for patients with AD who require alternatives to topical treatments.^1-3

AD can be a debilitating and uncomfortable condition for patients, and those who struggle to find relief with TCSs need alternative options. Image Credit: © New Africa - stock.adobe.com

AD is a chronic skin disorder characterized by constant itchy, inflamed, and dry skin that typically begins in childhood; however, it can develop at any age. Itching is a significant symptom and complication for patients with AD and scratching leads to worsening of redness, swelling, cracking, leaking clear fluid, crusting, and scaling, as well as increasing risk of infection. AD is typically controlled through healthy skin care practices, which can involve topical medications, moisturizers, baths, and antihistamines, as well as lifestyle modifications to mitigate flares.⁴

Lebrikizumab is a monoclonal antibody that targets and neutralizes interleukin (IL)-13, a proinflammatory Th2 cytokine central to the pathogenesis of AD. It is a 250 mg/2 mL injection administered as a monthly maintenance injection that can be used in conjunction with or without topical corticosteroids (TCS). The recommended starting dose is 500 mg, split into 2 injections, given at weeks 0 and 2 followed by 250 mg every 2 weeks until adequate clinical response is achieved.⁵

The success of lebrikizumab was demonstrated in the ADvocate 1, ADvocate 2, and ADhere trials evaluating lebrikizumab as a monotherapy or in combination with TCS in adults and children ages 12 to 18. ADvocate 1 and ADvocate 2 are 52-week randomized, double-blind, placebo-controlled, parallel-group, global, phase 3 studies designed to evaluate lebrikizumab as a monotherapy. According to data averaged from both studies, 38% percent of participants achieved clear or almost-clear skin at 16-weeks versus 12% with placebo, and 10% saw these results in as early as 4 weeks.^5,6

The capabilities of lebrikizumab were also reflected in ADhere, a 16-week randomized, double-blind, placebo-controlled, parallel-group, global, phase 3 study assessing the efficacy and safety of lebrikizumab in combination with (TCS) in 211 adults and children. Using the Investigator’s Global Assessment score (IGA), the authors found that, at week 16, 145 participants (41.2%) achieved an IGA score of 0 or 1 compared with the placebo group (22.1%).^5,6

AD can be a debilitating and uncomfortable condition for patients, and those who struggle to find relief with TCSs need alternative options. The lebrikizumab injection marks another advancement in care for AD, providing relief and reducing the risk of associated complications for patients.

"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," Kristin Belleson, president and CEO of the National Eczema Association, said in a news release. "The approval of [lebrikizumab] provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms."⁶

REFERENCES

1. Evaluation of the efficacy and safety of lebrikizumab (ly3650150) in moderate to severe atopic dermatitis (advocate1). ClinicalTrials.gov Identifier: NCT04146363. Updated November 30, 2011. Accessed September 16, 2024. https://clinicaltrials.gov/study/NCT04146363

2. Evaluation of the efficacy and safety of lebrikizumab (ly3650150) in moderate to severe atopic dermatitis (advocate2). ClinicalTrials.gov Identifier: NCT04178967. Updated May 24, 2023. Accessed September 16, 2024. https://clinicaltrials.gov/study/NCT04178967

3. Safety and efficacy of lebrikizumab (ly3650150) in combination with topical corticosteroid in moderate-to-severe atopic dermatitis. (adhere). ClinicalTrials.gov Identifier: NCT04250337. Updated May 9, 2022. Accessed September 16, 2024. https://clinicaltrials.gov/study/NCT04250337

4. E-cigarette exposure may increase risk of atopic dermatitis in children. Pharmacy Times. June 18, 2024. Accessed September 16, 2024. https://www.pharmacytimes.com/view/e-cigarette-exposure-may-increase-risk-of-atopic-dermatitis-in-children

5. Simpson E, 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. JAMA Dermatol. January 11, 2023. doi:10.1001/jamadermatol.2022.5534

6. Fda approves lilly's ebglyss™ (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. Lilly. September 13, 2024. Accessed September 16, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and