A Double-blind, Placebo-controlled Trial of Low Dose Infliximab in Ankylosing Spondylitis
Bibliographic record
Abstract
OBJECTIVE: The tumor necrosis factor-alpha (TNF-alpha) inhibitor infliximab (IFX) has been proven effective for the treatment of ankylosing spondylitis (AS). The primary objective of this double-blind, placebo-controlled study was to assess the safety and efficacy of low-dose (3 mg/kg q8w) IFX therapy in AS. METHODS: In the 12-week double-blind phase of the study, patients (N = 76) were randomized to infusions of placebo or IFX (3 mg/kg) at Weeks 0, 2, and 6. The primary endpoint was 20% improvement in ASsessments in Ankylosing Spondylitis criteria (ASAS20) at 12 weeks. In the open-label extension phase, all patients received scheduled IFX infusions (q 8 weeks) up to 46 weeks. Patients who did not meet target response criteria (i.e., BASDAI score did not improve by at least 50% and was > 3) at Weeks 22 or 38 had a dose increase to IFX 5 mg/kg. RESULTS: At 12 weeks, 53.8% of IFX-treated patients achieved ASAS20, compared with 30.6% of placebo-treated patients (p = 0.042). IFX-treated patients showed significant improvement in measures of disease activity, spinal mobility, and quality of life over the course of the study. During the extension phase, 68% of patients in the IFX group did not meet the clinical target and had an increase in the dose of IFX to 5 mg/kg by 38 weeks. In general, IFX was safe and well tolerated. Ten patients withdrew from the study for various reasons, with only 2 (2.6%) attributed to adverse events. CONCLUSION: IFX 3 mg/kg was effective in reducing the signs and symptoms of active AS, and was generally safe and well tolerated. Dose escalation to 5 mg/kg every 8 weeks was warranted in most patients to achieve the target clinical response of the study.
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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) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".