Effects of Low-dose Infliximab on Spinal Inflammation on Magnetic Resonance Imaging in Ankylosing Spondylitis
Bibliographic record
Abstract
In 2003, infliximab was the first anti-tumor necrosis factor (TNF) agent to be approved by both the European Medicines Agency and the US Food and Drug Administration for the treatment of active ankylosing spondylitis (AS) that responds insufficiently to standard therapy, usually nonsteroidal antiinflammatory drugs. All initial trials in AS — whether the initial open-label studies or placebo-controlled trials — were conducted using the 5 mg/kg infliximab dosing scheme1,2. In the placebo-controlled trial of 69 patients from Germany that led to approval of the drug, the interval between infliximab 5 mg/kg infusions was 6 weeks after the initial infusions at Week 0, Week 2, and Week 61. The dose and infusion interval of infliximab in AS clinical trials was chosen in analogy to the treatment schedule of infliximab in Crohn’s disease because according to the concept of spondyloarthritis as a group of interrelated diseases, Crohn’s disease appeared to be more akin to AS than rheumatoid arthritis (RA) and was the first spondyloarthropathy related disease for which approval of infliximab had been obtained. Therefore, the 5 mg/kg infliximab dose given every 6 or 8 weeks was used in the clinical trials in AS, and not the 3 mg/kg dose every 8 weeks that had been approved in RA. Unfortunately and in contrast to RA, no dose-finding studies with infliximab were ever performed in AS. Thus, from a scientific point of view we simply do not know whether infliximab 5 mg/kg every 6 weeks is the optimum treatment schedule for active AS. In recent years a few clinical studies were published using the 3 mg/kg dose of infliximab in AS given every 8 weeks. In summary, these usually small and open-label studies revealed response rates that were similar to3,4 or lower than5 … Address correspondence to Dr. M. Rudwaleit, Department of Rheumatology, Ev. Krankenhaus Hagen-Haspe, Brusebrinkstrasse 20, 58135 Hagen, Germany. E-mail: rudwaleit{at}evk-haspe.de
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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 | 0.001 | 0.001 |
| 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) | 0.004 | 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".