216. BARICITINIB, METHOTREXATE, OR BARICITINIB PLUS METHOTREXATE IN PATIENTS WITH MODERATELY-TO-SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAD RECEIVED LIMITED OR NO TREATMENT WITH DMARDS: EFFICACY AND SAFETY RESULTS FROM THE 52-WEEK PHASE 3 RA-BEGIN STUDY
Bibliographic record
Abstract
Background: Baricitinib, an oral JAK1/JAK2 inhibitor, improves disease activity with an acceptable safety profile in patients with active rheumatoid arthritis (RA). We report efficacy and safety data for baricitinib as monotherapy or in combination with methotrexate (MTX), compared with MTX, in patients with moderately-to-severely active RA and limited or no prior treatment with DMARDs. Methods: Patients (N = 584) with moderately-to-severely active RA who were DMARD-naïve (other than ≤3 doses of MTX) were randomized 4:3:4 to MTX (titrated to 20mg/week), baricitinib 4mg QD or baricitinib 4mg QD plus MTX for 52 weeks. Primary endpoint was non-inferiority of baricitinib monotherapy to MTX for ACR20 at week 24. Results: ACR20 response at week 24 was higher with baricitinib 4mg monotherapy versus MTX (77% vs 62%, p≤.01). Baricitinib plus MTX did not have increased benefit versus baricitinib monotherapy but was significantly superior to MTX for most outcomes, often from week one. Similar improvements were seen for ACR50/70 and DAS28. Clinical remission (DAS28<2.6, SDAI≤3.3, CDAI≤2.8) occurred in significantly higher proportions of patients receiving baricitinib monotherapy or baricitinib plus MTX versus MTX. The proportion of patients with no radiographic disease progression (ΔmTSS≤0.5) was 88% (p≤.01 vs MTX) for baricitinib plus MTX, 84% with baricitinib monotherapy (not significant vs MTX) and 78% with MTX. Compared with MTX, significant improvements were seen with baricitinib monotherapy and baricitinib plus MTX in physical function and pain (Table 1), and in all components of the WPAI-RA at week 24; fatigue was significantly improved with baricitinib monotherapy. Efficacy was sustained at week 52. Rates of treatment-emergent AEs, including infections, and serious AEs were similar across groups (Table 1). Laboratory changes (including liver abnormalities, lymphopenia), non-serious infections and AEs leading to interruption were generally less frequent with baricitinib monotherapy versus MTX or baricitinib plus MTX.
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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 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| 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".