Baseline Subgroup Characteristics of EXPAND: A Phase 3 Study of Siponimod (BAF312) for the Treatment of Secondary Progressive Multiple Sclerosis (P3.084)
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Bibliographic record
Abstract
OBJECTIVE:To present baseline subgroup analysis of the EXPAND study population. BACKGROUND:EXPAND is the largest, controlled phase 3 study in secondary progressive multiple sclerosis (SPMS) investigating the therapeutic potential of siponimod. DESIGN/METHODS:Patients with SPMS aged 18-60 years and Expanded Disability Status Scale (EDSS) score between 3.0-6.5 were randomized (2:1) to receive either siponimod or placebo. The primary outcome measure is time to 3-month confirmed disability progression as measured by increase in EDSS. RESULTS:As of August 2015 (end of recruitment), 1649 patients were enrolled (mean age 48.0±7.9 years). Relapses in the 2 years prior to study start were documented in 35.1[percnt] patients (n=578) whereas 64.5[percnt] were free of clinical relapses (n=1064) [information was missing for 0.4[percnt] (n=7)], and 55.2[percnt] had an EDSS ≥6. In patients with prior relapses, median duration (years) of MS since first symptom/conversion to SPMS were 14.3/1.8. Results of baseline clinical/MRI measures were (mean±SD): EDSS 5.4±1.0, T25FW 17.0±20.9 seconds (s), 9Hole Peg Test (9HPT) in dominant hand (DH) 32.0±22.7s, 12-item MS Walking Scale (MSWS12) 68.0±22.7, and T2 lesion volume (T2LV) 16306.8±17164.0 mm3. The corresponding values for patients without prior relapses were: median duration (years) of MS since first symptom/conversion to SPMS 16.9/3.12, EDSS 5.4±1.1, T25FW 17.7±31.6s, 9HPT-DH 35.4±37.1s, MSWS12 68.5±23.2, and T2LV 14701.5±15267.8 mm3. Most patients had no Gd+T1 lesions at baseline (patients with vs. without prior relapse: 71.5[percnt] vs. 81.5[percnt]; difference[95[percnt]CI]: 10.1[percnt][5.6;14.5]). In patients with EDSS of 3.0-5.5 (n=717) vs. those with high EDSS (6.0-6.5, n=910): median duration (years) from MS symptom-onset was 14.6 vs. 17.0; median duration (years) since conversion to SPMS was 1.94 vs. 3.35; T2LV (mean±SD) 13723.0±15052.3 mm3 vs. 16557.7±16683.8 mm3 and no Gd+T1 lesions in 79.2[percnt] vs. 72.9[percnt]. CONCLUSIONS:Subgroup analysis of the EXPAND baseline characteristics confirms the consistency of the SPMS profile, and considerable representation of non-relapsing patients. Study Supported by Novartis Pharma AG
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 it