The Results of <scp>ADVANCE</scp>‐<scp>CIDP IVIG</scp> Trial: Intravenous Immunoglobulin 10% Therapy With <scp>GAMMAGARD LIQUID</scp>/Kiovig for Treatment of Relapse in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Bibliographic record
Abstract
BACKGROUND: ADVANCE-CIDP IVIG evaluated the efficacy and safety of immune globulin infusion (human) 10% solution (IVIG 10%; GAMMAGARD LIQUID, also known as Kiovig) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as a rescue treatment for patients relapsing during the ADVANCE-CIDP 1 trial. METHODS: Open-label ADVANCE-CIDP IVIG included adult patients with confirmed CIDP relapse (≥ 1-point increase in adjusted Inflammatory Neuropathy Cause and Treatment [INCAT] disability scores from pre-treatment baseline) during ADVANCE-CIDP 1, which assessed the efficacy and safety of hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10%. Patients received an induction IVIG 10% dose (2 g/kg) followed by maintenance infusions at the same monthly equivalent dose of pre-randomization IVIG, 3-weekly for 6 months. The primary outcome was the responder rate (≥ 1-point decrease in adjusted INCAT scores at treatment cessation vs. pre-IVIG 10% baseline, in patients receiving placebo in ADVANCE-CIDP 1). Other outcomes included the responder rate across all patients relapsing on fSCIG 10% or placebo in ADVANCE-CIDP 1, time to functional improvement (≥ 1-point decrease in adjusted INCAT score), and change in adjusted INCAT scores and Rasch-built Overall Disability Scale (R-ODS) centile scores from pre-IVIG 10% baseline. RESULTS: Overall, 20 patients received IVIG 10% (n = 4 [fSCIG 10%-relapse group]; n = 16 [placebo-relapse group]). Responder rate (95% confidence interval) was 100.0% (80.6%-100.0%) in the placebo-relapse group and 95.0% (76.4%-99.1%) in the overall-relapse population. Across all patients, median time to functional improvement was 25 days. At treatment cessation, mean changes from pre-IVIG 10% baseline in adjusted INCAT and R-ODS centile scores were -1.9 and 12.9, respectively. CONCLUSIONS: IVIG 10% effectively treated CIDP relapse and improved functional abilities.
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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 | 0.002 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 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".