Safety and Tolerability of a New Intravenous Immunoglobulin (IVIg) 10% (KIg10) in Primary Immunodeficiency (PI) Adult Patients
Bibliographic record
Abstract
Introduction Intravenous immunoglobulin (IVIg) therapy is commonly used in the treatment of primary immunodeficiency (PI) disorders. This open-label, prospective, single-arm, multicenter phase III study in adult PI patients (KIG10_US3_PID01; NCT01581593) investigated efficacy, safety and pharmacokinetics (PK) of a new 10% IVIg product (KIg10), given 200 to 800 mg/kg every 21 or 28 days for 48 weeks. Objective Safety and tolerability endpoints from this study are reported here and included treatment-emergent adverse events (TEAEs) from Day 1 to Week 51/52. Methods Forty-seven patients received study treatment and were analyzed for safety and efficacy. As per protocol, the 1st infusion was administered at an initial rate of 1 mg/kg/min for 30 minutes. If well tolerated, the rate was progressively increased to a maximum of 8 mg/kg/min. The rate of administration of subsequent infusions progressively increased to a maximum of 8 mg/kg/min at 15-min intervals. Results Among both dosing schedules, 22 (46.8%) subjects reported 75 TEAEs. Most frequently reported (≥5%) were headache (25.5%), infusion-related reaction (10.6%), nausea, fatigue, and positive Coombs direct test (8.5% each). The most frequently reported (≥5%) infusional adverse event (AE) (defined as occurring during or within 72 hours after an infusion) were headache (25.5%), fatigue (14.9%), infusion-related reaction (10.6%), nausea (10.6%), positive Coombs direct test (10.6%), diarrhea (6.4%), dizziness (6.4%), and sinusitis (6.4%). No hemolysis events were reported, and no laboratory findings were suggestive of hemolysis associated with positive Coombs tests. No safety signal or trend was observed. None of the reported TEAEs were serious; no significant or life-threatening TEAEs were reported. No AEs led to study discontinuation, and no subjects died during the study due to an AE. Conclusion In study KIG10_US3_PID01, KIg10 showed a favorable safety profile and was well tolerated in adult patients with PI at the dosing schedules and infusion rates used.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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) | 0.001 | 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".