Lebrikizumab-Treated Patients With Atopic Dermatitis Had No Increase in Treatment-Emergent Adverse Events of Facial, Head, and Neck Erythema Compared to Placebo
Bibliographic record
Abstract
■ Use of some advanced systemic therapies has been associated with the development of facial, head, and neck erythema in patients with AD ■ Potential causes include Th2/Th1 cytokine profile switching, undiagnosed allergic contact dermatitis, reaction to facial Malassezia species, 1 colonization of Demodex mite, 2 resistance of facial AD to therapy, or drug eruption ■ Lebrikizumab is a monoclonal antibody that binds with high affinity and slow off-rate to IL-13, thereby blocking the downstream effects of IL-13 with high potency 3 ■ Lebrikizumab has demonstrated a positive benefit-risk profile and efficacy in Phase 2 and Phase 3 clinical trials for AD 4-7 OBJECTIVE ■ To assess the development of facial, head, and/or neck erythema in patients taking lebrikizumab for moderate-to-severe AD SUMMARY OF KEY FINDINGS ■ Treatment-emergent adverse events of facial, head, and/or neck erythema were not increased in patients with moderate-to-severe AD treated with lebrikizumab compared with placebo ■ The IR did not increase with increased number of exposure years to lebrikizumab CONCLUSIONS ■ The development of treatmentemergent adverse events of facial, head, and/or neck erythema is not more common in patients with moderate-tosevere AD taking lebrikizumab than those taking placebo ■ IR does not increase with increased number of exposure years to lebrikizumab METHODS Integrated Safety Analysis Study Design 8 PBO-Controlled, Weeks 0-16 Analysis Set ■ Patients treated with LEBRI 250 mg Q2W compared with placebo, for 16 weeks ■ 4 studies: ADvocate1, ADvocate2, ADhere, and a Phase 2b study All LEBRI Analysis Set ■ Patients who received ≥1 dose of LEBRI ■ 8 studies: ADvocate1, ADvocate2, ADhere, ADjoin, ADore, TREBLE, ARBAN, and a Phase 2b study Assessments and Statistical Analyses■ Treatment-emergent AEs were analyzed for specified terms related to facial, head, and neck erythema in adults and adolescents with moderate-to-severe AD based on patients who received ≥1 dose of study treatment, excluding 38 patients from one study site as the patient eligibility criteria could not be confirmed ■ Blinded medical review was completed ■ For PBO-controlled group, adj % and adj IRs were used to report AEs ■ For All LEBRI group, crude % and IRs were reported ■ Adj IRs were calculated as the number of patients reporting an event per 100 PYR RESULTS Development of Treatment-Emergent Facial, Head, and/or Neck Erythema a Limitations■ These findings need to be confirmed in the real-world setting Baseline Patient Demographics and Disease Characteristics
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".