Safety of tralokinumab in pediatric patients aged 12-17 years with moderate to severe atopic dermatitis: results from the phase 3 ECZTRA 6 trial
Bibliographic record
Abstract
Materials and Methods Study design• Adolescent patients were randomized 1:1:1 to subcutaneous tralokinumab 150 mg or 300 mg every 2 weeks (Q2W), or placebo for an initial treatment period of 16 weeks • Primary endpoints were Investigator's Global Assessment (IGA) score 0/1 and ≥75% improvement from baseline in Eczema Area and Severity Index (EASI-75) at Week 16 • Patients achieving primary endpoints without rescue treatment were re-randomized to tralokinumab Q2W or every 4 weeks (Q4W), at their same initial tralokinumab dosage for 36 weeks of maintenance treatment as shown in Figure 1, while Placebo responders continue in the Placebo Q2W • Patients not achieving primary endpoints at Week 16, those receiving rescue treatment from Week 2 to Week 16, and those meeting other specific criteria † were transferred to open-label treatment of tralokinumab 300 mg Q2W plus optional mild-to-moderate strength topical corticosteroids (TCS) • Key secondary endpoints include change in SCORing AD (SCORAD) from baseline to Week 16, reduction of worst daily pruritus numeric rating scale (NRS) (weekly average) of at least 4 from baseline to Week 16, and change in Children's Dermatology Life Quality Index (CDLQI) score from baseline to Week 16 Objective • To present detailed safety data up to 52 weeks for tralokinumab in pediatric patients aged 12-17 years with moderate-to-severe AD enrolled in the ECZTRA 6 trial (NCT03526861) Patient characteristics • Baseline demographic and clinical characteristics were comparable across treatment groups(Table 1) Results• Tralokinumab was well tolerated in pediatric patients aged 12-17 years with moderate-to-severe AD, with a favorable safety profile seen through 52 weeks of treatment• The safety profile was similar to that seen in adult phase 3 studies, with the frequency and type of AEs being generally consistent 9,10 • The frequency of conjunctivitis was low and similar between the tralokinumab and placebo arms at Week 16, with no increase observed up to Week 52• The frequency of acne was low across tralokinumab and placebo arms, supporting a favorable tolerability profile of tralokinumab in this age group• The detailed long-term safety data presented here add to the previous findings that tralokinumab is efficacious and well tolerated in this adolescent patient group 8 Conclusions
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| 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 | 0.001 | 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".