Natalizumab-Treated Patients with Multiple Sclerosis Have Low Rates of Brain Volume Decrease and Low MRI Disease Activity in the Long-term STRATA Study (P7.260)
Bibliographic record
Abstract
OBJECTIVE: To assess brain magnetic resonance imaging (MRI) disease activity and changes in brain volume in patients with relapsing multiple sclerosis receiving more than 6 years of natalizumab. BACKGROUND: The Safety of TYSABRI® Re-dosing and Treatment (STRATA) study is a single-arm, open-label, multinational study of natalizumab treatment in relapsing MS patients who completed the randomized AFFIRM, SENTINEL, and GLANCE trials and their open-label extensions (the “feeder studies”). DESIGN/METHODS: A subset of patients underwent 2 brain MRI scans 1 year apart, the first performed between weeks 242 and 347 and the second between weeks 292 and 397. Numbers of gadolinium-enhancing (Gd+) lesions, new nonenhancing T1 lesions, and new or enlarging T2 lesions, along with T2 lesion volume and annual percent brain volume change (PBVC) between scans, were evaluated. RESULTS: Of 716 patients dosed in STRATA, a subset of 268 had evaluable MRI data, including 80 patients receiving placebo and 188 patients receiving natalizumab in feeder studies. At the first reference MRI scan, the overall (n=267) mean (standard deviation [SD]) normalized brain volume was 1421.617 (83.536) mL. At the first and second annual scans, mean (SD) T2 lesion volume (n=268) was 11.843 (11.864) mL and 11.863 (11.916) mL, respectively; 1/267 patients (0.4[percnt]) and 0/268 patients (0[percnt]) had Gd+ lesions, respectively. At the second scan, 262/268 patients (97.8[percnt]) had no new or enlarging T2 lesions; 266/268 patients (99.3[percnt]) had no new nonenhancing T1 lesions. The overall (n=233) mean (SD) PBVC was −0.253 (0.4275) (mean [SD] time between scans, 319.4 [57.11] days); 71[percnt] and 46[percnt] of patients had brain volume decreases of <0.4[percnt] and <0.2[percnt], respectively. CONCLUSIONS: MRI disease activity and rates of annual brain volume decrease were low in patients treated with natalizumab for more than 6 years in STRATA. Study Supported by: Biogen Idec
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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) | 0.000 | 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) | 0.002 | 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".