Discontinuation of immunomodulator therapy in infliximab-treated children with Crohn disease; one year outcome evaluating influences on disease activity and infliximab antibody formation
Bibliographic record
Abstract
Clinical trial data indicates that regularly scheduled infliximab infusions are associated with a low rate of infliximab antibody formation, and that concomitant immunomodulation does not significantly enhance efficacy. In light of these data and the recent observation of hepatosplenic T-cell lymphoma in young patients with Crohn Disease receiving dual therapy, infliximab monotherapy has become common. We reviewed 1 year outcome following immunomodulator discontinuation. In May 2006, all patients receiving infliximab were systematically counseled concerning the occurrences of hepatosplenic T-cell lymphoma and were informed that the causative role for azathioprine or infliximab alone, or in combination was unclear. Following discussion, patients and families decided on subsequent therapy: monotherapy with infliximab, azathioprine alone, or continued dual therapy. Data concerning disease activity, infliximab antibody development, infusion reactions and loss of response were recorded in 1 year follow-up and compared with the preceding year. 27 patients, 16 male, mean age 14.7 +/- 2.27 years, with Crohn Disease had received infliximab maintenance therapy for 1.81 ±0.99 yrs in combination with azathioprine (n = 20), or methotrexate (n = 7). 25 discontinued immunomodulator therapy; 1 remained on dual therapy with methotrexate and infliximab; 1 discontinued infliximab. 5/25 (20%) required infliximab dose increases for active symptoms. Six children had detectable infliximab antibodies at follow-up. This was associated with diminution in response and severe infusion reaction in one. One child with infliximab antibodies switched therapy to an alternate anti-TNF agent. The table shows disease activity and infliximab regimens 6 months prior to change to monotherapy and at follow-up. Families wish to continue infliximab in spite of rare but serious adverse events. Discontinuation of concomitant immunomodulator therapy in children does not compromise short-term efficacy of infliximab.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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 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".