MAINTENANCE THERAPY WITH INFLIXIMAB EVERY 8 WEEKS IS SUPERIOR TO EVERY 12 WEEKS IN MAINTAINING RESPONSE AND REMISSION IN PEDIATRIC PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE
Bibliographic record
Abstract
The REACH study was a multicenter, randomized, open-label study that evaluated infliximab therapy in children with moderately to severely active Crohn's disease (CD). Patients (n = 112) with a Pediatric Crohn's Disease Activity Index (PCDAI) score >30 received infliximab 5 mg/kg at weeks 0, 2, and 6. Patients responding to treatment at week 10 were randomized to receive infliximab 5 mg/kg every 8 weeks or every 12 weeks through week 46 and followed through week 54. The primary endpoint was clinical response at week 10 (decrease from baseline in the PCDAI score ≥15 points, and a total score ≤30, at week 10). Clinical remission was defined as a PCDAI score ≤10 points. The median age was 13 years, the median duration of disease was 1.6 years. At week 10, 99 of 112 (88.4%) patients responded to infliximab (95% confidence interval: 82.5%, 94.3%) and 66 of 112 (58.9%) patients achieved clinical remission (95% confidence interval: 49.8%, 68.0%). At week 54, 33 of 52 (63.5%) and 29 of 52 (55.8%) patients receiving infliximab every 8 weeks were in clinical response and clinical remission, respectively, compared with 17 of 51 (33.3%) and 12 of 51 (23.5%) patients receiving treatment every 12 weeks (p = 0.002 and p < 0.001, respectively). The clinical response rates of patients with age <13 yrs and >13 yrs, with disease duration ≤ to 1 yr and >1 yr and with disease in the colon and in the small intestine were similar at week 10. Adverse events, and serious adverse events including serious infections were comparable among patients treated with infliximab every 8 weeks vs patients treated every 12 weeks. Safety findings in children were also comparable to those observed in adults. Response to infliximab approached 90% at week 10 and was similar regardless of age, disease duration, and location of disease. Maintenance dosing with infliximab every 8 weeks was superior to every 12 weeks dosing in maintaining response and remission.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 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".