Baseline Subgroup Characteristics of EXPAND: A Phase 3 Study of Siponimod (BAF312) for the Treatment of Secondary Progressive Multiple Sclerosis (P3.084)
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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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 | 0.004 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".