Comparison of Two Corticosteroid Pre-Infusion Regimens for Pegloticase in the United States: A Retrospective Analysis in Community Rheumatology Practices
Bibliographic record
Abstract
BACKGROUND: Pegloticase is a recombinant porcine-like uricase enzyme that is FDA-approved for the treatment of chronic refractory gout in adults. Some patients receiving pegloticase develop anti-drug antibodies, which leads to both loss of pegloticase efficacy and an increased risk for infusion reactions. In the pivotal trials, all patients received pre-infusion medications before each pegloticase dose, including intravenous (IV) hydrocortisone. In clinical practice, many clinicians use methylprednisolone for pre-infusion therapy with pegloticase; however, the efficacy of methylprednisolone compared with hydrocortisone as a pre-infusion medication for pegloticase has not been established. OBJECTIVE: The aim of this study was to compare the efficacy of methylprednisolone versus hydrocortisone as a pre-infusion medication for pegloticase. METHODS: Data were retrospectively collected from 92 qualifying patients treated with pegloticase and administered pre-infusion prophylaxis with either intravenous hydrocortisone or methylprednisolone. Patient demographics, steroid type and dose, duration of pegloticase therapy, overall number of infusions, and number of infusion reactions were assessed. RESULTS: Patients treated with methylprednisolone as a pre-infusion medication received on average 8.5 pegloticase infusions versus 4.9 infusions for patients who were treated with hydrocortisone (p < 0.001). In addition, a significantly lower proportion of patients receiving methylprednisolone had their course of therapy terminated early due to infusion reactions (8.2%) versus patients receiving hydrocortisone (41.9%, p < 0.01). CONCLUSION: In this retrospective chart-review project, patients were able to have a longer duration of pegloticase therapy, received a significantly greater number of infusions, and experienced fewer infusion reactions when methylprednisolone was used as the corticosteroid for pre-infusion prophylaxis compared with hydrocortisone.
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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 | 0.002 | 0.007 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 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".