Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-Life Community Registry
Bibliographic record
Abstract
Infliximab (IFX) is a therapeutic monoclonal antibody targeting TNFα indicated in the treatment of a number of chronic inflammatory diseases. IFX is administered by intravenous infusion and may be associated with infusion reactions (IR). RemiTRAC Infusion is a prospective Canadian observational registry in which IFX infusions are followed to document the incidence and management of IR, pre-medication use and adverse events (AE). An IR was defined as any AE occurring during the infusion or within 1 hour post infusion. Since its inception in 2005, 1398 patients have been enrolled and 18,121 infusions were recorded. There were 253 Crohn's disease patients (16%) and 80 UC patients (6%). The majority of remaining patients (64%) were treated for rheumatologic conditions. A total of 181/1398 patients reported at least one IR (13%). Only 292/18,121 infusions resulted in an IR (1.6%) and most IRs were mild to moderate in severity (94%). The most common infusion AE was pruritus which occurred in 14.2% of IR. Flushing (9.9%), urticaria (9.2%), nausea (6.3%) dyspnoea (6.0%) and chest discomfort (5.0%) were the only other infusion AEs occurring in ≥5% of IR. Pre-medication, which included anti-histamines, intravenous steroids and/or acetaminophen, was used in 42% of infusions and 1.8% of them were associated with an IR. Interestingly, infusions without any pre-medication were associated with a 1.4% incidence of IR. Infusions pre-medicated with anti-histamines, either alone or in combination with steroids, were associated with a significantly higher incidence of IR, up to 3.3% in the presence of anti-histamines (P < 0.0001) and up to 5.3% in the presence of anti-histamines and steroids (P < 0.0001). In contrast, only acetaminophen pre-medication was associated with a reduced incidence of IR (0.8%, P < 0.0001). We noted that infusions immediately following an IR were associated with a 31% incidence of a subsequent IR (44/140) despite the prevalent use of prophylactic pre-medication. This likely explains the higher incidence of IR in the presence of anti-histamines and/or steroids. This registry shows that, in community-based infusion clinics, infusion reactions to IFX are rare in incidence and largely mild to moderate in nature. Only the use of acetaminophen pre-medication was associated with a lower incidence of IR.
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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 | 0.003 | 0.013 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.002 | 0.004 |
| Science and technology studies | 0.001 | 0.000 |
| 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".