Safety and Tolerability Results From the DECIDE Study: A Phase 3 Active-Comparator Study of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis (P7.230)
Bibliographic record
Abstract
OBJECTIVE: To evaluate the safety and tolerability of daclizumab high-yield process (DAC HYP) in patients with relapsing-remitting multiple sclerosis (RRMS) over a 2-3 year treatment period. BACKGROUND: DAC HYP is a humanized monoclonal antibody specific for the α subunit (CD25) of the interleukin-2 receptor that reversibly modulates interleukin-2 signaling. DESIGN/METHODS: DECIDE was a randomized, double-blind, double-dummy, active-controlled Phase 3 study comparing subcutaneous DAC HYP 150mg once every 4 weeks with intramuscular interferon beta-1a (IFNβ-1a) 30mcg once weekly for 96 to 144 weeks. RESULTS: 1841 patients were randomized and treated (DAC HYP, n=919; IFNβ-1a, n=922). The overall incidence of adverse events (AEs) was similar in both treatment groups (91[percnt]). Excluding MS relapse, there was a higher incidence of serious AEs (15[percnt] and 10[percnt]) and discontinuations due to AEs (14[percnt] and 9[percnt]) in the DAC HYP group versus the IFNβ-1a group, respectively. The most common AEs (蠅10[percnt] excluding MS relapse) in the DAC HYP and IFNβ-1a groups, respectively, were nasopharyngitis (25[percnt] and 21[percnt]), headache (17[percnt] and 19[percnt]), upper respiratory tract infection (16[percnt] and 13[percnt]), pyrexia (11[percnt] and 15[percnt]), urinary tract infection (10[percnt] and 11[percnt]), injection site pain (10[percnt] and 11[percnt]) and influenza-like illness (10[percnt] and 37[percnt]). There were 5 deaths (1 DAC HYP; 4 IFNβ-1a); none were related to study treatment. There was an increased incidence of serious infections (4[percnt] and 2[percnt]), serious cutaneous events (2[percnt] and <1[percnt]), and ALT or AST >5 times the ULN (6[percnt] and 3[percnt]) in the DAC HYP group versus the IFNβ-1a group, respectively. CONCLUSIONS: DAC HYP over a 2-3 year treatment period was associated with an increased risk of infection, cutaneous events, and liver function test elevations that were manageable with standard monitoring and medical care. 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 | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".