2014 Las Vegas Dermatology Scientific Abstracts
Bibliographic record
Abstract
BACKGROUND: Psoriasis is associated with cardiovascular risk and an increased frequency of major adverse cardiovascular events (MACE). 1 Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, demonstrated rapid, robust, and sustained efficacy with an acceptable safety profile up to 52 weeks in clinical studies of subjects with moderate-tosevere plaque psoriasis.OBJECTIVE: Here, we report the safety analysis of data pooled from secukinumab trials that assessed the incidence of cardiovascular safety.METHODS: We evaluated pooled data from 10 randomized, double-blind, phase 2 and 3 studies.Subjects were treated with subcutaneous secukinumab 300 mg (n = 1410; 1178 subject-years of exposure) or 150 mg (n = 1395; 1142 subject-years of exposure), etanercept 50 mg (n = 323; active comparator; 294 subject-years of exposure), or placebo (n = 793; 201 subjectyears of exposure) for up to 52 weeks.RESULTS: Overall, 13 MACE were reported, with an incidence per 100 subject-years of: secukinumab 300 mg, 0.51 (6 cases); secukinumab 150 mg, 0.44 (5 cases); etanercept, 0.34 (1 case); placebo, 0.50 (1 case).No dose dependence was evident.To verify potential MACE, an independent, blinded Cardiovascular and Cerebrovascular Safety Adjudication Committee was established.Two cases (1 for secukinumab 300 mg [myocardial infarction]; 1 for 150 mg [moyamoya disease]) did not meet prespecified adjudication criteria (the 300 mg dose level event initially reported as a myocardial infarction was reclassified as an electrocardiographic abnormality).The exposure-adjusted rate of confirmed incident MACE was thus 0.42 for secukinumab 300 mg and 0.35 for 150 mg.All confirmed MACE incidence occurred in subjects with prior/active cardiovascular disease or risk factors.Risk difference between secukinumab and placebo was calculated through meta-analysis across placebo-controlled studies (all phase 2 and four phase 3 studies).Meta-analyses showed that there was no difference in risk of developing MACE between secukinumab and placebo during the placebo-controlled induction periods.LIMITATIONS: Data for etanercept is available from only one phase 3 study.Placebo data were mostly from the first 12 weeks of treatment.Mode of administration varied between studies, and range of doses tested was broad (intravenous doses of 3 to 30 mg/kg and subcutaneous doses of 25 to 300 mg).CONCLU-SION: MACE incidence, regardless of the outcomes based on prespecified adjudication criteria, was infrequent and comparable among each secukinumab dose level, etanercept, and placebo.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.501 | 0.256 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".