21 Long-term safety and efficacy of nipocalimab in generalized myasthenia gravis: vivacity-MG3 open-label extension phase results
Bibliographic record
Abstract
a:2:{s:4:"lang";s:2:"en";s:7:"content";s:1375:" Objective To evaluate the long-term safety and efficacy of nipocalimab, an FcRn blocker, in patients with generalized myasthenia gravis (gMG) from the Vivacity-MG3 (NCT04951622) open-label extension (OLE) phase. Background There is a significant need for effective and safe treatments for gMG. In autoantibody-positive patients, nipocalimab showed marked improvement over baseline in the MG-ADL score compared to placebo in the phase 3 Vivacity-MG3 study. Methods In a 24-week double-blind study, autoantibody-positive (n=153) and triple-autoantibody-negative patients (n=43) with inadequately controlled gMG were randomized 1:1 to receive either nipocalimab+standard of care (SOC) or placebo+SOC. Those who completed the double-blind phase could enter the ongoing OLE. Safety was assessed for patients receiving at least one dose of study drug. Results Of 137 autoantibody-positive patients from the double-blind phase, 81 and 37 patients were assessed at OLE weeks 24 and 48, respectively. The mean change in MG-ADL was –5.73 and –5.97, respectively. Nipocalimab was well-tolerated with no new safety findings reported. Conclusion Nipocalimab maintained sustained disease control over 72 weeks, as measured by the MG-ADL scale, in autoantibody-positive gMG patients. GReynol1{at}ITS.JNJ.com ";}
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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".