4CPS-079 Indirect comparison of il-13 inhibitors plus topical corticosteroids in moderate to severe atopic dermatitis
Bibliographic record
Abstract
Background and Importance Lebrikizumab, tralokinumab and dupilumab are anti-interleukin-13 monoclonal antibody used as therapy in patients with moderate to severe atopic dermatitis (msAD). There are no direct comparisons among them. Aim and Objectives To establish whether lebrikizumab plus topical corticosteroids (L-TC), tralokinumab plus topical corticosteroids (T-TC) and dupilumab plus topical corticosteroids (D-TC) can be declared equivalent therapeutic alternatives (ETA) in patients with msAD through an adjusted indirect treatment comparison (ITC) using a common comparator. Material and Methods A bibliographic search was conducted to identify phase III clinical trial (CTs) with L-TC or T-TC or D-TC with similar populations, duration and endpoints. Inclusion criteria were: phase III, randomised, double-blinded, placebo controlled and in patients with msAD. The 90% improvement in Eczema Area and Severity Index (EASI90) at week 16 was used as the main variable. An ITC of L-TC versus T-TC and L-TC vs D-TC was performed using the Bucher method, using the Indirect Treatment Comparisons calculator from the Canadian Agency for Health Technology. Delta value (Δ, maximum difference as a clinical criterion of equivalence) was calculated using half of the ARR in EASI90 obtained in the pivotal CT of dupilumab (pooled ARR=29%; Δ =15%). The results were analysed graphically and the relative position of the 95% CI and the equivalence margin were observed. Positioning was established following the ETA Guide. Results Included three CTs in the ITC between L-TC (Adhere), T-TC (ECZTRA 3) and D-TC (Liberty ad Chronos). The difference in EASI90 expressed as ARR (IC95%) of L-TC versus T-TC, and L-TC versus D-TC, was: 6.6 (-9–22.2) y -11 (-27– 5). Applying the ETA Guide, L-TC, T-TC and D-TC could be considered ETA, being the probability of clinically relevant difference <50% (most of the 95% CI is in the equivalence range), and the failure does not involve serious/irreversible damage. Conclusion and Relevance The ITC showed no statistically significant and clinically relevant differences in EASI90 between anti-interleukin-13 plus topical corticosteroids. These drugs could be considered ETA in most patients with msDA. References and/or Acknowledgements Conflict of Interest No conflict of interest.
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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 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.008 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.025 | 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".