Drug Update · Dermatology

FDA Approves Lebrikizumab for Mod-to-Severe AD: 43% IGA 0/1 ADvocate1

July 10, 2026

FDA approval date

2024-09-13

Primary endpoint (ADvocate 1)

IGA (0,1) with ≥2-point improvement at Week 16: 43% lebrikizumab vs 13% placebo [12]

Adolescent pooled result (ADvocate1&2)

IGA (0,1) 46.6% lebrikizumab (N = 67) vs 14.3% placebo (N = 35) at Week 16 [1]

Approved dosing

500 mg at Week 0 and Week 2, then 250 mg every 2 weeks; maintenance 250 mg every 4 or 8 weeks [8][12]

Clinical Perspective

Information about specific clinician types affected was not available in the provided source excerpts; the approval applies to adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis ^[2]^[3]. The source-confirmed data support that lebrikizumab increased the proportion of patients achieving clear or almost-clear skin (IGA 0/1) at Week 16 compared with placebo, and produced higher EASI-75 and EASI-90 rates in ADvocate trials ^[3]^[1]. An important remaining clinical question is how response durability and longer-term comparative safety beyond the 52-week maintenance evaluations will compare with other systemic therapies for moderate-to-severe atopic dermatitis?

Dr. Rohan Gupta, MBBS, MD (Dermatology, Venereology & Leprosy) · Dermatology

The FDA approved lebrikizumab (EBGLYSS) for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg on 2024-09-13 based on the ADvocate development program. The ADvocate 1 trial showed 43% of patients achieved Investigator Global Assessment (IGA 0,1) with ≥2-point improvement at Week 16 versus 13% with placebo ^[3]^[2].

Clinical Context

Lebrikizumab (trade name EBGLYSS) is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds interleukin-13 (IL-13) and inhibits IL-13 signaling; it is manufactured by Eli Lilly and Company ^[2]^[3]. The FDA indication covers adults and pediatric patients 12 years and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies or when those therapies are not advisable; EBGLYSS may be used with or without topical corticosteroids ^[2]^[3]. The regulatory decision relied on three randomized, double-blind, placebo-controlled Phase 3 trials in the ADvocate program (ADvocate 1, ADvocate 2) and the concomitant-therapy trial ADhere, which evaluated skin clearance, EASI responses, and itch outcomes at Week 16 and maintenance through Week 52 ^[3].

Key Findings

ADvocate 1 (Phase 3) primary endpoint: 43% of subjects randomized to lebrikizumab achieved IGA 0 or 1 with ≥2-point improvement at Week 16 versus 13% with placebo (difference 30%; 95% CI not reproduced here) ^[3].
ADvocate 1 also reported EASI-75 of 59% with lebrikizumab versus 16% with placebo, and EASI-90 of 38% versus 9% with placebo at Week 16 ^[3].
ADvocate 2 showed concordant results: IGA (0,1) 33% with lebrikizumab versus 11% with placebo; EASI-75 52% versus 18%; EASI-90 31% versus 10% at Week 16 ^[3].
In adolescents (pooled ADvocate 1 & 2), the subgroup analysis reported IGA (0,1) 46.6% with lebrikizumab (N = 67) versus 14.3% with placebo (N = 35) at Week 16, with corresponding EASI-75 62.0% versus 17.3% and EASI-90 40.7% versus 11.5% (pooled results) ^[1].

These efficacy results across trials supported the FDA approval for moderate-to-severe atopic dermatitis ^[3]^[1].

Safety & Tolerability

Conjunctivitis was reported as a common adverse reaction in the pivotal trials and labeling ^[2]^[3].
Injection site reactions were reported as a common adverse reaction in the pivotal trials and labeling ^[2]^[3].
Herpes zoster was reported as a common adverse reaction in the pivotal trials and labeling ^[2]^[3].
Hypersensitivity reactions, including angioedema and urticaria, are listed in warnings and precautions in the prescribing information ^[2].
Parasitic (helminth) infection guidance and vaccination precautions are described in labeling; treat pre-existing helminth infections prior to initiating therapy and avoid live vaccines during treatment ^[2].

All safety statements above are drawn from the FDA labeling and trial summaries ^[2]^[3].

Study Design

The FDA approval was supported by three randomized, double-blind, placebo-controlled Phase 3 trials (ADvocate 1, ADvocate 2, ADhere) enrolling a total of 1,062 subjects 12 years and older with moderate-to-severe atopic dermatitis; the trials used subcutaneous lebrikizumab versus placebo with the primary endpoint measured at Week 16 ^[3]. The primary efficacy endpoint was the proportion of subjects achieving IGA score of 0 or 1 with a ≥2-point improvement at Week 16 ^[3]. Maintenance and durability of response were evaluated through Week 52 in ADvocate 1 and ADvocate 2. [Detail] was not available in the provided source excerpts was written where specific administrative or funding details were not included in the excerpted materials ^[3]^[1].

FAQ

Q1 What is lebrikizumab (EBGLYSS) approved for?

Lebrikizumab (EBGLYSS) is approved for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. EBGLYSS can be used with or without topical corticosteroids.

Q2 How does lebrikizumab work?

Lebrikizumab-lbkz is a human IgG4 monoclonal antibody that binds interleukin-13 (IL-13) and inhibits IL-13 signaling through the IL-4Rα/IL-13Rα1 receptor complex. By inhibiting IL-13-induced signaling, lebrikizumab reduces downstream type 2 inflammatory responses implicated in atopic dermatitis.

Q3 What is the recommended dose of lebrikizumab (EBGLYSS)?

The recommended subcutaneous dosage is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg (one injection) every 2 weeks until Week 16 or later when adequate clinical response is achieved. The maintenance dose may be 250 mg every 4 weeks or 250 mg every 8 weeks as described in the prescribing information. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects reported with lebrikizumab?

The most commonly reported adverse reactions (≥1%) in the pivotal trials and labeling include conjunctivitis, injection site reactions, and herpes zoster. Hypersensitivity events including angioedema and urticaria are described in warnings and precautions. The label also includes guidance on helminth infections and vaccination considerations.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves Lebrikizumab for Mod-to-Severe AD: 43% IGA 0/1 ADvocate1

FDA Approves Lebrikizumab for Mod-to-Severe AD: 43% IGA 0/1 ADvocate1

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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