Multiple Sclerosis Patients with No Evidence of Disease Activity in the 2-Year AFFIRM Study Have Better Outcomes with Long-term Natalizumab Treatment than Patients Who Had Evidence of Disease Activity in AFFIRM (P7.221)
Bibliographic record
Abstract
OBJECTIVE: To assess annualized relapse rates (ARRs) and disability progression in patients with relapsing multiple sclerosis (MS) on long-term natalizumab therapy. BACKGROUND: The Safety of TYSABRI® Re-dosing and Treatment (STRATA) study is a single-arm, open-label, multinational study of natalizumab treatment in patients who participated in prior studies, including AFFIRM. Over the 2-year AFFIRM study, 37[percnt] of natalizumab-treated patients and 7[percnt] of placebo-treated patients had no evidence of disease activity (NEDA), including both clinical activity (no 12-week-confirmed Expanded Disability Status Scale [EDSS] progression and no relapses) and magnetic resonance imaging (MRI) activity (no gadolinium-enhancing lesions or new T2 lesions). DESIGN/METHODS: Analyses included STRATA patients who had received natalizumab during AFFIRM. ARRs and cumulative probabilities of 24-week-confirmed EDSS progression (蠅1.0-point increase in EDSS score) and improvement (蠅1.0-point decrease in EDSS score) from baseline were evaluated during STRATA by NEDA status (NEDA+/NEDA−) during AFFIRM. RESULTS: At STRATA baseline, there were 177 AFFIRM NEDA+ patients (167 on natalizumab and 10 on placebo) and 415 AFFIRM NEDA− patients (249 on natalizumab and 166 on placebo). Among AFFIRM natalizumab patients, who were observed for 2350.3 patient-years in STRATA, the overall mean ARR was 0.084 and 0.131 in AFFIRM NEDA+ and NEDA− patients, respectively (P=0.0263). At week 384 in STRATA, among AFFIRM natalizumab patients, cumulative probabilities of 24-week-confirmed EDSS progression and improvement were 23.3[percnt] and 38.7[percnt], respectively, in AFFIRM NEDA+ patients versus probabilities of 37.5[percnt] and 26.8[percnt], respectively, in AFFIRM NEDA− patients (P=0.026 for progression; P=0.029 for improvement). CONCLUSIONS: Over approximately 8 years in STRATA, natalizumab-treated AFFIRM NEDA+ patients had significantly lower ARRs, lower rates of confirmed EDSS progression, and higher rates of confirmed EDSS improvement than natalizumab-treated AFFIRM NEDA− patients. These findings suggest that NEDA over 2 years has prognostic value for at least the duration of this study. Study Supported by: Biogen Idec
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| 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".