103. Long-Term Safety and Efficacy of Certolizumab Pegol in Combination with Methotrexate in the Treatment of Rheumatoid Arthritis: 5-Year Results from a 52-Week Randomized Controlled Trial and Open-Label Extension Study
Bibliographic record
Abstract
Background: In the RAPID1 randomized controlled trial (RCT), certolizumab pegol (CZP) every 2 weeks (Q2W) plus MTX over 52 weeks provided rapid improvements in signs and symptoms and inhibition of radiographic damage in patients with active RA. Here we examine the safety and efficacy of CZP plus MTX over 5 years in RA. Methods: Eligible patients were treated in the open-label extension (OLE) to RAPID1 (NCT00175877) with CZP 400 mg Q2W, reduced to 200 mg Q2W after ≥6 months, plus MTX. Primary objective of the OLE was to monitor safety; secondary objective was to assess efficacy. Combined safety data from RCT and OLE are presented to Wk334 for all patients receiving ≥1 dose of CZP in RCT or OLE (Safety population, N = 958). ACR20/50/70, DAS28 (ESR) and HAQ-DI are reported to Wk256 for CZP patients who completed the 52-week RCT (CZP Completers, N = 508) and for all patients randomized to CZP 400 mg or 200 mg in RCT (ITT population, N = 783). Change from baseline in modified Total Sharp Score (mTSS) and percentage of patients with radiographic non-progression (definition: mTSS change from RCT baseline ≤ 0.5) are reported to Wk148 for CZP Completers. Missing categorical data were imputed by modified non-responder imputation, continuous data by last observation carried forward, and radiographic data by linear extrapolation. Kaplan-Meier analysis was used to estimate patient retention.
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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 | 0.005 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.007 | 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".