Daclizumab HYP Reduced Brain MRI Lesion Activity Compared With Interferon Beta-1a: Results from the DECIDE Study (P7.252)
Bibliographic record
Abstract
OBJECTIVE: To evaluate the impact of treatment with daclizumab high-yield process (DAC HYP) versus interferon beta-1a (IFNβ-1a) on brain magnetic resonance imaging (MRI) lesion activity in patients with relapsing-remitting multiple sclerosis (RRMS). BACKGROUND: In the 52-week SELECT study, subcutaneous DAC HYP 150mg every 4 weeks significantly reduced clinical multiple sclerosis disease activity and brain MRI activity compared with placebo in patients with RRMS. DESIGN/METHODS: DECIDE was a randomized, double-blind, Phase 3 study of subcutaneous DAC HYP 150mg once every 4 weeks versus intramuscular IFNβ-1a 30mcg once weekly for 96 to 144 weeks in RRMS patients. Prospective brain magnetic resonance imaging (MRI) endpoints included: numbers of new/newly-enlarging T2 hyperintense lesions, gadolinium-enhancing lesions, or new T1 hypointense lesions; volume of T2 hyperintense lesions and T1 hypointense (black hole) lesions; and change in whole brain volume over 96 weeks. RESULTS: 1841 patients were randomized and treated (DAC HYP, n=919; IFNβ-1a, n=922). At Week 96, DAC HYP treatment versus IFNβ-1a resulted in 54[percnt], 65[percnt], and 52[percnt] reductions in the number of new/enlarging T2 hyperintense lesions, gadolinium-enhancing lesions, and new T1 hypointense (black holes) lesions (all P<0.0001). Similar significant reductions in these 3 MRI lesion parameters also were observed at Week 24 (P<0.0001). The median volumes of new/newly enlarging T2 hyperintense and T1 hypointense lesions were significantly smaller at Week 24 (both P<0.04) and Week 96 (both P<0.0001) for DAC HYP versus IFNβ-1a. The mean annualized percentage reduction in brain volume was smaller in the DAC HYP group compared with the IFNβ-1a group between Weeks 0 to 24 (0.67 vs 0.74; P=0.03) and Weeks 24 to 96 (0.52 vs 0.56; P<0.0001). CONCLUSIONS: DAC HYP reduced focal inflammatory lesions and brain atrophy over a 2-3 year treatment period compared with IFNβ-1a. Study Supported by: Biogen Idec and AbbVie Biotherapeutics.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.004 | 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".