A Phase II Trial to Assess the Efficacy, Safety and Feasibility of 20[percnt] Subcutaneous Immunoglobulin in Patients with Myasthenia Gravis Exacerbation - Interim Analysis of Safety and Feasibility (P3.175)
Bibliographic record
Abstract
OBJECTIVE: An interim analysis to assess the safety and feasibility of 20[percnt] Subcutaneous Immunoglobulin (SCIg; (Hizentra) in patients with MG exacerbation. BACKGROUND: The University of Alberta MG program is the primary site of an ongoing investigator initiated, multicenter clinical trial to assess the feasibility, safety and efficacy of 20[percnt] SCIg in MG exacerbation. METHODS: A dose of 2gm/kg of SCIg was infused in a flexible regimen over 4 weeks. Patient reported adverse effects, infusion site reactions, incidence of hemolysis, serum Ig levels, and patient compliance and satisfaction were monitored during the study period. RESULTS: Eight patients have completed the study with a total of 101 infusions at four abdominal sites (total sites = 404). All patients were able to infuse the full-prescribed dose. Mean total dose was 180.8gms (range: 104 to 204gms), mean volume 904ml per patient (range 520 - 1020ml). All patients needed only a single training session. Pump rather than manual infusions were associated with improved compliance. There was no incidence of hemolysis or any other serious adverse event. Minor infusion site reactions (mild redness, and itching) and a mild flu like syndrome and headache were reported with some infusions. None caused discontinuation of infusions or any significant effect on routine activities. One patient intolerant to all brands of IVIg was able infuse the full SCIg dose. Serum IgG levels gradually increased by about 200[percnt] at study end. Patient reported survey scores indicate reasonable satisfaction with SCIg infusions (mean score: 5; range: 0 - 7). CONCLUSIONS: Preliminary results indicate that despite its large volume SCIg appears to be well tolerated at the standard IVIg dose for neuromuscular diseases i.e. 2gm/kg infused over 4 weeks. Infusion site reactions as well as systemic side effects appear to be mild and rare. Further studies are needed to confirm these preliminary results.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".