Continuous Tralokinumab Treatment over 4 Years in Adults with Moderate-to-Severe Atopic Dermatitis Provides Long-Term Disease Control
Bibliographic record
Abstract
Introduction: Tralokinumab, a monoclonal antibody that specifically neutralizes interleukin-13, is approved for the treatment of moderate-to-severe AD in multiple countries. Clinical trials of up to 52-week duration showed tralokinumab was effective and well-tolerated as monotherapy and in combination with TCS. ECZTEND (NCT03587805) is an ongoing open-label, 5-yr extension trial investigating the long-term safety and efficacy of tralokinumab ± optional TCS. To assess the efficacy of long-term tralokinumab treatment, we conducted a post hoc interim subgroup analysis restricted to the largest, most homogenous patient population, with the longest treatment duration. Methods: Adult patients with moderate-to-severe AD who were continuously treated with tralokinumab ± optional TCS for 52 weeks in the phase 3 parents trials (PTs) ECZTRA 1 (NCT03131648) or ECZTRA 2 (NCT03160885) and for up to 152 weeks in ECZTEND as of data cutoff 04/30/2022 were included. Endpoints included proportion of patients achieving IGA 0/1, EASI-75 or EASI-90 relative to PT baseline, EASI ≤7, worst weekly pruritus (itch) NRS ≤4, and DLQI ≤5. Results are presented using observed data (AO). Sensitivity analyses on patients who completed Week152 in ECZTEND (or who withdrew, but were enrolled in the study ≥152 weeks prior to cutoff) were performed using mNRI with discontinuations due to AEs or lack of efficacy imputed as non-responders and a 2-step MI for other missing data. Results: 347 patients with mean age (SD) of 42.2 (14.5) years and mean EASI (SD) of 30.8 (13.7) at PT baseline were included. After 4 years of total tralokinumab treatment (at Week 152 in ECZTEND), IGA 0/1 [% (n/N)] was observed in 52.6% (92/175) of patients. EASI-75 {% (n/N) [95% CI]} was achieved in 84.5% (147/174) [78.4, 89.1] of patients AO, and 73.4% (254.8/347) [68.6, 78.3] using mNRI. EASI-90 was achieved in 64.4% (112/174) [57.0, 71.1] of patients AO, and 53.4% (185.2/347) [47.8, 59.0] using mNRI. EASI ≤7 was observed in 84.5% (147/174), itch NRS ≤4 in 68.0% (119/175), and DLQI ≤5 in 79.0% (128/162) of patients. The safety profile was favorable and consistent with earlier analyses, with no new safety signals arising with continued tralokinumab use. Conclusions: Continuous use of tralokinumab ± optional TCS provided long-term disease control over 4 years in adult patients 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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.004 |
| 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) | 0.003 | 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".