Daclizumab HYP Versus Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis: Primary Results of the DECIDE Study (S4.003)
Bibliographic record
Abstract
OBJECTIVE: To evaluate the efficacy of daclizumab high-yield process (DAC HYP) versus interferon beta-1a (IFNβ-1a) in patients with relapsing-remitting multiple sclerosis (RRMS). BACKGROUND: Daclizumab HYP is a humanized monoclonal antibody against CD25 that results in a reversible modulation of interleukin-2 signaling. DESIGN/METHODS: DECIDE was a randomized, double-blind, active-controlled study comparing subcutaneous DAC HYP 150mg once every 4 weeks with intramuscular IFNβ-1a 30mcg once weekly for 96 to 144 weeks. The primary endpoint was the annualized relapse rate (ARR). RESULTS: At baseline, patients (N=1841; DAC HYP, n=919; IFNβ-1a, n=922) had a mean (SD) age of 36.3 (9.3), EDSS score of 2.5 (1.2), 21[percnt] had highly active MS, and 41[percnt] had previously used disease-modifying therapy. Treatment with DAC HYP versus IFNβ-1a resulted in a 45[percnt] reduction in the ARR (P<0.0001) and a 41[percnt] reduction in the proportion of patients who relapsed (nominal P<0.0001). For DAC HYP versus IFNβ-1a, there was a 54[percnt] reduction in the number of new/enlarging T2 hyperintense lesions at week 96 (P<0.0001). For DAC HYP versus IFNβ-1a, the risk of 3-month confirmed disability progression was reduced by 16[percnt] (P=0.158). The risk of clinically meaningful worsening in the physical impact of MS (蠅7.5-point worsening on the Multiple Sclerosis Impact Scale-29 physical subscale) was reduced by 24[percnt] in DAC HYP-treated patients compared with IFNβ-1a-treated patients (nominal P=0.0176). Infections, cutaneous events, and hepatic events were more common in the DAC HYP group than in the IFNβ-1a group. CONCLUSIONS: DAC HYP demonstrated superior efficacy compared with IFNβ-1a across key clinical, radiographic, and patient-reported MS outcome measures in relapsing MS patients. Risks were manageable with appropriate monitoring. Study Supported by: Biogen Idec and AbbVie Biotherapeutics.
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How this classification was reachedexpand
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 | 0.001 | 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 | 0.001 |
| 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".