046 Efficacy and safety of intravenous immunoglobulin (IVIG) IGPRO10 in chronic inflammatory demyelinating polyneuropathy (CIDP)
Bibliographic record
Abstract
Introduction We analysed the efficacy and safety of IVIG IgPro10 (CSL Behring) in two CIDP studies: PRIMA and PATH. Methods PRIMA was a prospective, open-label, single-arm study in 28 CIDP patients (n=13 IVIG-pretreated; n=15 untreated) investigating efficacy and safety of IgPro10 for induction (2 g/kg) and maintenance therapy (1 g/kg every 3 weeks for 21 weeks). This regimen was also used for 207 IVIG-pretreated patients during the 10–13 week pre-randomization phase of the PATH study (before randomization to subcutaneous immunoglobulin maintenance therapy or placebo). Both studies investigated a 1-point decrease in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score as a response parameter, and evaluated changes in mean grip strength and Medical Research Council (MRC) score. Treatment-emergent adverse events (AEs) were assessed. Results Response rate was 76.9% (95% confidence interval [CI] 49.7–91.8) in PRIMA (IVIG-pretreated patients) at week 21% and 72.9% (95%CI 66.5–78.5) in PATH at week 13; median time to first INCAT response was 3.0 and 3.7 weeks, respectively. Median (Q1;Q3) improvements in outcome measures (baseline to last observation) for PRIMA pre-treated patients and PATH, respectively, were: INCAT, −2.0 (-3.0;−1.0) and −1.0 (-2.0;0.0) points; grip strength, 5.0 (-9.0;22.0) and 9.4 (1.3;18.8) kPa; and MRC score, 5.0 (3.0;10.0) and 3.0 (0.0;6.0) points. In the PRIMA safety population (n=28), 108 AEs occurred in 22 (78.6%) patients (0.417/infusion); 284 AEs in 100 (48.3%) patients (0.175/infusion) were reported in the PATH safety population (n=207). Headache was the most frequent AE. Causally related serious AEs in PRIMA and PATH occurred in 2 and 7 patients, respectively. Conclusion Similar efficacy results of IgPro10 in CIDP were observed in PRIMA and the PATH pre-randomization period. IgPro10 is well tolerated, with clinically meaningful improvement in disability in CIDP patients. Study Support CSL Behring
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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 | 0.004 | 0.002 |
| 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 | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 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".