4-Year Follow-up of Delayed-Release Dimethyl Fumarate Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS): Integrated Clinical Efficacy Data From DEFINE, CONFIRM, and the ENDORSE Extension Study (P3.173)
Why this work is in the frame
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Bibliographic record
Abstract
OBJECTIVE: To report 4-year interim clinical efficacy outcomes with delayed-release dimethyl fumarate (DMF) from DEFINE, CONFIRM, and ENDORSE. BACKGROUND: Delayed-release DMF demonstrated efficacy and safety in patients with RRMS in the 2-year, Phase 3 DEFINE and CONFIRM studies. ENDORSE is an ongoing, 5-year, dose-blind extension study evaluating long-term safety and efficacy. DESIGN/METHODS: In ENDORSE, patients randomized in DEFINE/CONFIRM to delayed-release DMF 240 mg twice- (BID) or three-times daily (TID) continued on the same dosage. Patients randomized to placebo (PBO) or glatiramer acetate (GA) were re-randomized 1:1 to delayed-release DMF BID or TID. Efficacy was analyzed (June 12, 2013 cutoff) according to treatment arm in parent/extension study: BID/BID, TID/TID, PBO/BID, PBO/TID, GA/BID, GA/TID. RESULTS: Of 2,079 patients completing DEFINE/CONFIRM, 1,736 were dosed in ENDORSE (n=501 [BID/BID], 502 [TID/TID], 249 [PBO/BID], 248 [PBO/TID], 118 [GA/BID], and 118 [GA/TID]). Both BID/BID and TID/TID patients showed consistent efficacy over 4 years (2 years in parent studies, 2 years ENDORSE). Adjusted annualized relapse rate (ARR) (95% confidence interval [CI]) during Year 1 and Year 2 in parent studies and Year 3 and Year 4 in ENDORSE were: 0.202 (0.162-0.252), 0.163 (0.128-0.208), 0.138 (0.104-0.183), and 0.142 (0.108-0.187) for BID/BID, and 0.239 (0.195-0.294), 0.123 (0.094-0.162), 0.167 (0.128-0.217), and 0.198 (0.155-0.252) for TID/TID, respectively. For patients switching treatment from PBO or GA, ARR (95% CI) in Year 4 (second year of delayed-release DMF treatment) was 0.126 (0.083-0.194) for PBO/BID and 0.138 (0.092-0.209) for PBO/TID, and 0.128 (0.070, 0.233) for GA/BID, and 0.184 (0.105, 0.325) for GA/TID patient groups. Disability progression remained low among patients who continued treatment with delayed-release DMF. CONCLUSIONS: Treatment with delayed-release DMF resulted in low relapse rates and disability progression sustained over 4 years. Along with neuroradiologic efficacy and an acceptable safety profile, results support its potential as a long-term treatment option for relapsing MS. Study Supported by: Biogen Idec
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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) | 0.000 | 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 it