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 machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 source (direct Gemma or distilled Codex), 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".