Prospective observational analysis of the efficacy and safety of low-dose (3 mg/kg) infliximab in ankylosing spondylitis: 4-year followup.
Bibliographic record
Abstract
OBJECTIVE: Although there are now compelling data that infliximab is effective for the treatment of AS, most studies have evaluated a dose of 5 mg/kg rather than the 3 mg/kg dose recommended for patients with RA. We assessed the effectiveness and safety of a 3 mg/kg dose of infliximab in normal clinical practice over several years of followup. METHODS: All consecutive patients with AS starting infliximab therapy at 3 mg/kg IV at 0, 2, and 6 weeks and q 2 months between April 2000 and December 2004 were included. Data were systematically collected at baseline, at 14 weeks, and every 6 months thereafter to 4 years or withdrawal. Data included demographic characteristics, Bath AS indices, adverse events, and reasons for withdrawal. Survival taking low-dose infliximab was analyzed by the Kaplan-Meier method with withdrawal for lack of efficacy and/or adverse events and requirement for dose escalation constituting the endpoint. RESULTS: Thirty-four patients (M:F = 26:8), mean age 44.9 years, mean disease duration 17.1 years, and mean BASDAI of 6.4, were studied, of whom 17 had active peripheral synovitis. Median duration of treatment with low-dose infliximab was 1507 days. Fourteen discontinued therapy after a median of 91 days, 6 for adverse events, 6 for lack of efficacy, and 2 were lost to followup. Five (14.7%) patients required dose escalation. Effectiveness demonstrable at 1 year was maintained over 4 years. We did not identify any significant baseline predictors of maintenance on low dose infliximab for > or = 2 years. CONCLUSION: Low-dose (3 mg/kg) infliximab therapy is associated with sustained effectiveness in patients with AS in the real-world setting.
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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 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| 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) | 0.001 | 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".