Six-year safety and efficacy outcomes with first-line ofatumumab in recently diagnosed treatment-naive patients with relapsing multiple sclerosis
Bibliographic record
Abstract
BACKGROUND: We report ofatumumab's longer-term safety and efficacy in recently diagnosed (≤3 years) treatment-naive (RDTN) people living with relapsing multiple sclerosis (plwRMS). METHODS: Safety analyses included RDTN participants receiving at least 1 ofatumumab dose in ASCLEPIOS I/II or other ALITHIOS feeder studies (APLIOS and APOLITOS). Efficacy analyses included participants randomised to ofatumumab in ASCLEPIOS I/II and treated continuously for up to 6 years. Efficacy outcomes include annualised relapse rate (ARR), MRI lesions, no evidence of disease activity-3 (NEDA-3), cognitive processing speed, and work status. RESULTS: The safety analysis included 409 RDTN plwRMS. Exposure-adjusted incidence rates of serious infections and malignancies did not increase to the cut-off date (25-Sep-2025) of 6 years. Over 6 years, mean IgG levels remained stable and IgG was above the lower limit of normal (LLN: 5.65 g/L) in 98.0% of participants at all assessments; mean IgM levels decreased but IgM remained above LLN (0.4 g/L) in 64.1% of participants at all assessments. Of 314 RDTN participants receiving ofatumumab in ASCLEPIOS I/II (efficacy analysis), 233 entered ALITHIOS, and at data cut-off 181 (77.7%, 181/233) were still receiving ofatumumab. ARR decreased from 0.112 (Year 1) to 0.030 (Year 6). An almost complete suppression of MRI lesions was observed up to Year 6. NEDA-3 at Year 6 was observed in 94.4% of participants. At 6 years, up to 70.6% of participants experienced clinically meaningful improvement in cognitive processing speed. Reduced work absenteeism versus baseline was observed. CONCLUSIONS: Findings support ofatumumab's highly favourable longer-term benefit-risk profile as first-line therapy for plwRMS.
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How this classification was reachedexpand
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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".