What Were the Key Phase 3 Trial Results for Ebglyss?
Ebglyss (lebrikizumab-lbkz), approved by the FDA in September 2024 for moderate-to-severe atopic dermatitis in adults and children 12+ weighing at least 40 kg whose condition isn't controlled by topical therapies, showed efficacy in two pivotal Phase 3 trials: ADvocate1 and ADvocate2.[1][2]
In both trials, patients had baseline IgE levels ≤1,000 IU/mL and an EASI score ≥16. At week 16, 43% of those on Ebglyss (250 mg every 2 weeks after initial doses) achieved clear or almost clear skin (IGA 0/1) versus 13% on placebo. EASI-75 (75% improvement in Eczema Area and Severity Index) was reached by 59% versus 12% on placebo.[1]
ADjoin, a long-term extension, showed sustained response: 82% maintained IGA 0/1 through week 36 with dosing every 2 or 4 weeks.[1]
How Does Ebglyss Compare to Dupixent in Trials?
Head-to-head data is limited, but in ADvocate2's active comparator arm, Ebglyss achieved IGA 0/1 in 33% at week 16 versus 27% for dupilumab (300 mg every 2 weeks). EASI-75 rates were 52% versus 47%. Differences were not statistically significant for non-inferiority, but Ebglyss had a faster itch reduction onset (33% improvement by week 1 vs. 25% for dupilumab).[2][3]
Week 16 IGA 0/1 rates:
| Treatment | ADvocate1 (vs placebo) | ADvocate2 (vs placebo) | ADvocate2 (vs dupilumab) |
|-----------|-------------------------|-------------------------|---------------------------|
| Ebglyss | 43% | 33% | 33% |
| Comparator | 13% | 11% | 27% (dupilumab) |
What Safety Data Came from the Trials?
Across 1,324 patients in ADvocate1/2/ADjoin (up to 56 weeks), common side effects included conjunctivitis (7%), injection site reactions (3%), herpes infections (2%), and dry eye (1%). Serious events occurred in 5% of Ebglyss patients vs. 4% placebo; discontinuation due to adverse events was 2% vs. 1%.[1][2]
No new safety signals emerged long-term. Conjunctivitis was mostly mild/moderate and didn't lead to higher discontinuations than dupilumab (10% in comparator arm).[3]
When Did Trials Start and What Populations Were Studied?
ADvocate trials ran from 2019-2022, enrolling ~700 patients each with moderate-to-severe atopic dermatitis (failed topicals). About 33% had prior biologic exposure. ADhere (Phase 3 in adolescents) supported pediatric approval, showing 34% IGA 0/1 at week 16 vs. 10% placebo.[1][4]
Ongoing trials include ADjoin-Asia (NCT04800315) and head-to-head vs. other biologics.
What Do Real-World or Post-Approval Concerns Look Like?
Pre-approval data holds; post-marketing surveillance is early. Patient forums highlight conjunctivitis as a top complaint, similar to IL-13/IL-4 inhibitors. No patent data directly ties to trials, but Eli Lilly holds exclusivity until ~2036.[5]
Sources
[1]: FDA Ebglyss Label
[2]: NEJM: Lebrikizumab Phase 3 Results
[3]: Lilly ADvocate2 Data
[4]: ClinicalTrials.gov ADhere (NCT04146363)
[5]: DrugPatentWatch: Ebglyss