402 Efficacy of lebrikizumab in adolescent patients with moderate-to-severe atopic dermatitis: 16-week results from three randomized phase 3 clinical trials
Bibliographic record
Abstract
Abstract Lebrikizumab, a high-affinity monoclonal antibody targeting IL-13, previously demonstrated clinical efficacy in adults and adolescents with atopic dermatitis (AD) in phase 3 trials. Here we evaluate 16-week efficacy outcomes of lebrikizumab in adolescent patients with moderate-to-severe AD from 3 randomized, double-blind, placebo-controlled phase 3 trials: ADvocate1, ADvocate2 and ADhere. Eligible adolescents (≥12 to <18 years weighing ≥40 kg) were randomized 2 : 1 to subcutaneous lebrikizumab (loading doses of 500 mg at Baseline and Week 2 followed by 250 mg every 2 weeks) or placebo in ADvocate1&2 as monotherapy, and in combination with topical corticosteroids (TCS) in ADhere. Efficacy analyses at Week 16 included IGA (0,1) with ≥2-point improvement, EASI-75, and Pruritus NRS ≥4-point improvement. Adolescent data from ADvocate1 and ADvocate2 were pooled, and ADhere data were analysed separately. ADvocate2 and ADhere analyses were performed on a modified population, excluding 10 adolescent patients from a single site whose eligibility could not be confirmed. Combined adolescent 16-week results from ADvocate1 and ADvocate2 [lebrikizumab (n = 67) vs. placebo (n = 35)] were IGA (0,1) with ≥2-point improvement from baseline 46.6% vs. 14.3% (P < 0.01), EASI-75 62.0% vs. 17.3% (P < 0.001) and Pruritus NRS ≥4-point improvement from baseline 48.9% vs. 13.1% (P < 0.01), respectively. The corresponding proportions in ADhere (lebrikizumab + TCS, n = 32; placebo + TCS, n = 14) were IGA (0,1) 57.3% vs. 28.6% (P = 0.071), EASI-75 88.0% vs. 57.1%, (P < 0.05) and Pruritus NRS 45.8% vs. 13.8%, (P = 0.078), respectively. Lebrikizumab treatment with or without TCS demonstrated clinical efficacy in adolescents with moderate-to-severe AD.
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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 | 0.005 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 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".