Measuring the effect of rozanolixizumab using the Myasthenia Gravis Impairment Index: analyses from the randomized phase 3 MycarinG study
Bibliographic record
Abstract
BACKGROUND: Generalized myasthenia gravis (gMG) is an autoimmune disease characterized by fluctuating muscle weakness. The MG Impairment Index (MGII) incorporates patients' perspectives (22 items) and physician evaluation (6 items) of impairment. We evaluated the effect of rozanolixizumab using the MGII in the randomized, double-blind, placebo-controlled, Phase 3 MycarinG study. METHODS: Adult patients with gMG were randomized 1:1:1 to once-weekly rozanolixizumab 7 mg/kg, 10 mg/kg or placebo for 6 weeks. MGII assessment was optional. Exploratory MGII analyses included change from baseline (CFB) to Day 43 in total score and ocular/generalized subscores; higher scores reflect greater impairment. Post hoc analyses included responder rates (≥ 5.5-point improvement) and achievement of patient-acceptable symptom state (PASS; ≤ 10 points, patient-reported items only). RESULTS: Overall, 200 patients received rozanolixizumab 7 mg/kg (n = 66), 10 mg/kg (n = 67) or placebo (n = 67). The MGII was completed by 144/200 (72.0%) patients. Mean CFB in MGII total score was greater in the rozanolixizumab groups versus placebo; mean CFB in ocular and generalized subscores was consistent with the total score. At Day 43, 57.1%, 83.3% and 40.4% of patients, respectively, were responders, and 30.8%, 39.2% and 7.7%, respectively, achieved MGII PASS. Responsiveness correlations between MGII total score CFB and MG-ADL anchor at Day 43 demonstrated a Spearman's correlation coefficient of 0.5991 (p < 0.0001). CONCLUSION: These findings further support efficacy analyses from MycarinG to highlight the benefit of rozanolixizumab in patients with gMG and demonstrate the utility of the MGII in evaluating patient-relevant symptoms following treatment. TRIAL REGISTRATION: NCT03971422 (registered May 29, 2019).
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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 | 0.009 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".