Efficacy and Safety of Tralokinumab in US Adults with Moderate-to-Severe Atopic Dermatitis: A Post-hoc Analysis of ECZTRA3
Bibliographic record
Abstract
Background: Tralokinumab, a monoclonal antibody that specifically neutralizes interleukin (IL)-13, is approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD). Tralokinumab was studied in ECZTRA3 (NCT03363854), a randomized, double-blind, multi-national, placebo-controlled Phase 3 trial of tralokinumab in adults with moderate-to-severe AD. Objective: We conducted a post-hoc analysis in the United States (US) subset of ECZTRA3 patients to inform healthcare practitioners and payers on the efficacy and safety of tralokinumab in the US setting. Methods: Patients were treated with either 300 mg tralokinumab (n=63) or placebo (n=25) every 2 weeks (Q2W) in combination with TCS as needed for an initial 16 weeks. Thereafter, tralokinumab-treated patients continued with either Q2W dosing or Q4W+TCS for 16 additional weeks. Primary, secondary, and safety endpoints of the ECZTRA3 US subset were evaluated at 16 and 32 weeks following main statistical analyses (previously published). Results: At Week 16, 37.1% tralokinumab+TCS vs 12.0% placebo+TCS reached Investigator’s Global Assessment (IGA) 0/1 (nominal P=0.039); 56.5% of tralokinumab+TCS vs 24.0% placebo+TCS (nominal P=0.012) achieved the Eczema Area and Severity Index (EASI)-75. Secondary, patient-reported outcomes including itch score and health-related quality of life (HRQoL) were also improved at Week 16 versus baseline, more so for tralokinumab+TCS group. Tralokinumab was well tolerated, with an overall safety profile comparable to placebo. Conclusions: Consistent with the full ECZTRA3 population, US patients with moderate-to-severe AD treated with tralokinumab+TCS as needed achieved greater symptom relief, reductions in disease severity and improvement of HRQoL than placebo+TCS, with comparable safety.
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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 | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".