Long-term Efficacy of Delayed-Release Dimethyl Fumarate for Relapsing-Remitting Multiple Sclerosis According to Prior Therapy: Integrated Analysis of the DEFINE, CONFIRM, and ENDORSE Studies (P7.229)
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
OBJECTIVE: To report long-term efficacy of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) in relapsing-remitting multiple sclerosis (RRMS) patients treated with prior approved interferon β-1a/b or glatiramer acetate (GA) therapy (ABCR). BACKGROUND: DMF demonstrated efficacy and safety in 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 (TID) daily in DEFINE/CONFIRM continued the same dosage in ENDORSE. Patients randomized to placebo (PBO) or GA (CONFIRM only) were re-randomized 1:1 to DMF BID or TID. Data were analyzed (May 14, 2014 cutoff) by treatment in parent/extension study. BID data are reported, as this represents the approved dosage; GA/BID data are not included as patient numbers were low. Minimum follow-up was 5 years in patients remaining on study: BID/BID patients received 蠅5 years DMF; PBO/BID patients received 2 years PBO (DEFINE/CONFIRM) followed by 蠅3 years DMF (ENDORSE). RESULTS: Subgroups included 267 BID/BID and 133 PBO/BID ABCR-naïve patients, 93 BID/BID and 53 PBO/BID with 1 prior ABCR, and 124 BID/BID and 68 PBO/BID with 蠅1 prior ABCR. Over the entire observation period, adjusted annualized relapse rates (95[percnt] confidence interval) for BID/BID and PBO/BID were 0.123 (0.097-0.157) and 0.207 (0.152-0.283) in naïve patients, 0.171 (0.125-0.234) and 0.256 (0.173-0.377) with 1 prior ABCR, and 0.195 (0.151-0.252) and 0.253 (0.181-0.353) with 蠅1 prior ABCR. CONCLUSIONS: Among ABCR-naïve and prior ABCR-treated patients, relapse rates remained low over 5 years with sustained DMF treatment, consistent with beneficial effects of early treatment. Results support the reported clinical efficacy of DMF in patients who previously received ABCR therapy from the integrated analysis of DEFINE/CONFIRM. However, results should be interpreted cautiously as this was a post-hoc analysis and sample sizes were small. Study Supported by: Biogen Idec
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| 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