219. Long-Term Safety and Efficacy of Golimumab in the Treatment of Ankylosing Spondylitis: Results Through 5 Years of a Randomized, Placebo-Controlled Trial
Bibliographic record
Abstract
Background: Golimumab (GLM) has demonstrated significant and sustained clinical efficacy and an acceptable safety profile through 2 years of the phase 3, randomized, PBO-controlled, GO-RAISE study in pts with AS. GLM safety/efficacy in AS pts receiving GLM50 mg and/or 100 mg through 5 years was evaluated. Methods: 356pts with AS were randomized to s.c. PBO, GLM50 mg, or GLM100 mg q4w. At week 16, pts with inadequate response early escaped (EE) with blinded dose adjustments (PBO to GLM50 mg, GLM50 mg to 100 mg). At week 24, pts still receiving PBO crossed over to GLM50 mg. Pts continued double-blind treatment through week 100. The long-term extension started with the week 104 GLM injection. Pts received GLM q4w for ∼5 years (final injection at week 252). After unblinding at week 104 and at the investigator’s discretion, pts receiving GLM50 mg could increase their dose to 100 mg; pts receiving GLM100 mg could decrease dose to 50 mg; concomitant DMARD, corticosteroid, and NSAID therapy could be adjusted.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.002 |
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".