2025 Late-Breaking Science Abstracts
Bibliographic record
Abstract
ObjectiveTo assess efficacy and safety of telitacicept in a phase 3, multicenter, randomized, placebo-controlled study in patients with generalized myasthenia gravis (gMG). BackgroundIn gMG, B cells produce autoantibodies targeting the acetylcholine receptor (AChR) and muscle-specific tyrosine kinase (MuSK), disrupting neuromuscular transmission, leading to muscle weakness.Telitacicept, a novel fusion protein, inhibits B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), reducing B-cell activity, and showed efficacy and tolerability in a phase 2 study of patients with gMG. Design/MethodsEligible patients were adults with confirmed gMG diagnosis, on stable standard treatment, with positive serum AChR or MuSK antibody; Myasthenia Gravis Foundation of America (MGFA) class II, III, or IVa; Myasthenia Gravis-Activities of Daily Living (MG-ADL) score 6; and Quantitative Myasthenia Gravis (QMG) score 8.During a 24-week, double-blind period, patients were randomized 1: 1 to weekly subcutaneous telitacicept (240 mg) or placebo and then entered a 24-week, open-label period (weekly telitacicept [240 mg]).The primary end point was change in MG-ADL at week 24.Secondary end points included change in QMG, and the proportion of patients with 3-point reduction in MG-ADL and 5-point reduction in QMG.Immunologic and safety parameters were assessed. Results114 eligible patients were randomized (telitacicept, n = 57; placebo, n = 57).At week 24, change in MG-ADL was -6.4 and -1.6 with telitacicept and placebo, respectively (p < 0.001); change in QMG was -7.8 and -1.9, respectively (p < 0.001).98.1% and 12.0% of telitacicept-treated and placebo patients had 3-point reduction in MG-ADL, respectively (p < 0.001); 87.0% and 16.0% of patients had 5-point reduction in QMG, respectively (p < 0.001).Immunoglobulin (Ig) G, A, and M levels decreased with telitacicept and were unchanged with placebo.The most frequently reported adverse event with telitacicept was IgM decrease. ConclusionsTelitacicept demonstrated clinically a meaningful efficacy and safety profile consistent with data from studies in various indications.The 24week, open-label period is ongoing.
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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 | 0.005 | 0.011 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.004 | 0.001 |
| 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".