Efficacy and Safety of Lebrikizumab Is Maintained to Two Years in Patients With Moderate-to-Severe Atopic Dermatitis
Bibliographic record
Abstract
BACKGROUND■ Lebrikizumab is a novel monoclonal antibody that binds with high affinity and slow off-rate to IL-13, thereby blocking the downstream effects of with high potency 1■ The efficacy and safety of lebrikizumab have been investigated in a number of Phase 3 trials including: ADvocate1 (NCT04146363), ADvocate2NCT04178967), ADhere (NCT04250337), and ADjoin (NCT04392154) 2-4 ■ Lebrikizumab (with or without TCS) was efficacious in providing clinically meaningful improvements in the signs and symptoms of AD through Week 52 in adult and adolescent patients with moderate-to-severe AD 2-4 OBJECTIVE ■ To evaluate the efficacy and safety of lebrikizumab through 2 years in the long-term extension study ADjoin in responders a enrolled from the parent studies ADvocate1&2 and ADhere a Responders in ADvocate 1&2 and ADhere were defined as those patients who achieved either EASI 75 or IGA (0,1) following 16 weeks of LEBRI 250mg Q2W treatment without use of rescue therapy Note: Statistical results of the primary and major secondary endpoints for ADvocate1&2 and ADhere were confirmed through replicate statistical programming, validation, and quality reviews 2-4 SUMMARY OF KEY FINDINGS CONCLUSIONS ■ Lebrikizumab provided durable efficacy in skin and itch outcomes through 2 years of treatment with both monthly and 2-week dosing ■ The lebrikizumab safety data in ADjoin is consistent with previous lebrikizumab studies in patients with moderate-to-severe AD, and no new safety signals were noted METHODS Study Design Key Eligibility Criteria Parent Study (ADvocate 1&2 or ADhere) ■ Adults (≥18 years) and adolescents (≥12 to <18 years; weight ≥40 kg) ■ Diagnosis of AD, as defined by the American Academy of Dermatology Consensus Criteria, for ≥1 year before screening ■ Moderate-to-severe AD, defined as having all the following at the baseline visit:-EASI ≥16 -IGA ≥3 -BSA involvement ≥10%
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".