Five-Year Follow-up of Delayed-Release Dimethyl Fumarate in RRMS: Integrated Clinical Efficacy Data from the DEFINE, CONFIRM, and ENDORSE Studies (P7.234)
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Bibliographic record
Abstract
OBJECTIVE: To report long-term (5-year minimum follow-up) clinical efficacy outcomes with delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) in patients with relapsing-remitting multiple sclerosis (RRMS). BACKGROUND: DMF demonstrated broad efficacy and an acceptable safety profile in RRMS patients in the phase 3 DEFINE and CONFIRM studies; ENDORSE is an 8-year extension of DEFINE/CONFIRM. DESIGN/METHODS: Patients randomized to DMF 240 mg twice (BID) or three times daily (TID) in DEFINE/CONFIRM continued the same dosage in ENDORSE. Patients randomized to placebo (PBO; DEFINE/CONFIRM) or glatiramer acetate (GA; CONFIRM) were re-randomized 1:1 to DMF 240 mg BID or TID. Data were analyzed (May 14, 2014 cutoff) by treatment arm in parent/extension study: BID/BID, TID/TID, PBO/BID, PBO/TID, GA/BID, GA/TID. Results for DMF 240 mg BID are reported, as this represents the maintenance dosage of DMF approved for treatment of patients with relapsing MS. 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], 118 [GA/TID]). Adjusted annualized relapse rates (ARRs) (95[percnt] confidence interval [CI]) for BID/BID during Years 1 and 2 (DEFINE/CONFIRM) and Years 3, 4, and 5 (ENDORSE) were 0.202 (0.162-0.252), 0.163 (0.128-0.208), 0.139 (0.105-0.184), 0.143 (0.109-0.188), and 0.138 (0.104- 0.183), respectively. For patients switching treatment from PBO or GA, the ARRs (95[percnt] CI) during Years 3, 4, and 5 were 0.176 (0.121-0.255), 0.131 (0.086-0.198), and 0.107 (0.068- 0.171) for PBO/BID and 0.182 (0.109-0.302), 0.137 (0.077-0.245), and 0.118 (0.062-0.225) for GA/BID, respectively. Estimated probability of disability progression remained low among patients continuing DMF. CONCLUSIONS: Treatment with DMF was associated with low relapse rates and estimated probability of disability progression over 5 years; these results support its use as a long-term treatment option for patients with RRMS. 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 | 0.003 |
| 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 | 0.001 | 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