Effect of Two Dosing Frequencies of Subcutaneous Interferon (scIFN) β-1a on MRI Lesion and Brain Volume Changes in Patients with a First Clinical Demyelinating Event (FCDE): 5-year Results of Phase III REFLEX Study Extension (REFLEXION) (P7.250)
Bibliographic record
Abstract
OBJECTIVE:Determine the effects of scIFN β-1a, initiated early after an FCDE, on changes in MRI lesion volume and brain volume over 5 years compared with delayed treatment (DT). BACKGROUND:Early treatment with scIFN β-1a 44 µg three times weekly (tiw) or once weekly (qw) significantly delayed McDonald MS diagnosis (2005 criteria) and CDMS versus placebo over 24 months in the REFLEX study. In the REFLEX extension (REFLEXION), early initiation of scIFN β-1a significantly benefited MRI lesion and brain volume changes at 36 months. DESIGN/METHODS:In REFLEX, patients were randomized to double-blind scIFN β-1a 44 µg tiw or qw, or placebo for 24 months; upon CDMS diagnosis, patients switched to open-label scIFN β-1a 44 µg tiw. In REFLEXION, placebo patients not reaching CDMS were switched to tiw (DT); qw and tiw patients not reaching CDMS continued their regimen for up to 60 months after randomization. MRI and brain volume assessments were performed annually. Statistical analyses were exploratory; all p-values were nominal. RESULTS: 402/517 (77.8[percnt]) REFLEX patients entered REFLEXION (DT, n=133; tiw, n=127; qw, n=142). At Month 60, mean numbers of new T2, gadolinium-enhancing and T1 hypointense lesions/subject/scan were lower with scIFN β-1a 44 µg qw (all p<0.05) and tiw versus DT (all p<0.001). For DT versus tiw, mean (SD) change from baseline to last observed value (LOV) in T2 lesion volume was -367.9 (2633.79) mm3 versus -33.6 (2513.13) mm3 (p<0.001) and for T1 hypointense lesion volume was 165.1 (863.4) mm3 versus 329.8 (939.33) mm3 (p=0.007). Mean (SD) percentage change from baseline in brain volume at LOV was DT -1.49 (1.46)[percnt], qw -1.33 (1.35)[percnt] and tiw -1.70 (1.58)[percnt] (p=0.032 qw versus tiw). CONCLUSIONS:Over 5 years, scIFN β-1a, initiated early after an FCDE, improved changes in MRI lesion number and volume, and brain volume compared with DT. Study Supported by:Merck Serono.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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 | 0.001 | 0.001 |
| 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".