BASELINE CHARACTERISTICS AND RESPONSE TO EVINACUMAB IN WOMEN AND MEN WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN THE ELIPSE OLE STUDY
Bibliographic record
Abstract
CVD Prevention – Primary and Secondary Evinacumab is an angiopoietin-like protein 3 inhibitor developed for the treatment of homozygous familial hypercholesterolemia (HoFH), a rare condition characterized by extremely elevated low-density lipoprotein -cholesterol (LDL-C) levels and premature atherosclerotic cardiovascular disease. Women are under-represented in cardiovascular clinical trials. The ELIPSE OLE study involved 116 HoFH participants treated with evinacumab among which 49.1% were women. The aim of this study was to compare response to evinacumab in women and men in the ELIPSE OLE study. Data on 57 women and 59 men were analyzed from ELIPSE OLE, an open-label phase 3 extension study conducted in 12 countries to assess the safety and efficacy of evinacumab in HoFH (NCT03409744). Participants were aged >12 years and on stable background lipid-lowering therapy (LLT). Patients received evinacumab 15 mg/kg intravenously every 4 weeks. The primary efficacy endpoint was the reduction in LDL-C concentration from baseline to week-24. Follow-up was up to 192 weeks. Baseline characteristics and response to evinacumab were compared between woman and men of the whole sample and by age subgroups. There were no significant gender specific differences in HoFH diagnostic criteria, pathogenic variants, demographics, background LLT except that lomitapide was used less in women. Baseline LDL-C [mean (standard deviation)] tended to be higher in women aged 18 to <50 years than men: 8.4 (5.4) vs 6.4 (3.5) mmol/L. Following treatment with evinacumab, percentage decrease in LDL-C at week-24 was 43.6% in the overall cohort and sustained over time. Evinacumab significantly decreased LDL-C in both genders, regardless of age and LLT including other LDL receptor independent treatments (apheresis or lomitapide), but LDL-C reduction tended to be more pronounced in women. In a study where half were women, evinacumab led to substantial LDL-C reduction in HoFH patients of both genders, regardless of genotype or background LLT.
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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 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".