Rheumatoid arthritis oral abstractsO01. Efficacy and Safety of Baricitinib Versus Placebo and Adalimumab in Patients with Moderately to Severely Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: Summary Results from the 52-Week Phase 3 RA-Beam Study
Bibliographic record
Abstract
Background: Baricitinib, an oral JAK1/JAK2 inhibitor, has shown promising results in patients with active rheumatoid arthritis (RA). We present efficacy and safety results from the phase 3 RA-BEAM study in patients with active RA and inadequate response (IR) to methotrexate (MTX). Methods: Patients with moderate to severe RA and MTX-IR were randomized 3:3:2 to placebo, baricitinib 4 mg QD or adalimumab 40 mg biweekly. All patients continued stable background MTX therapy. Non-responders were rescued at week 16. At week 24, patients receiving placebo switched to baricitinib 4 mg QD. The study compared baricitinib, placebo and adalimumab using multiple endpoints, including non-inferiority and superiority testing; the primary endpoint was baricitinib versus placebo ACR20 response at week 12. Results: Of 1305 randomized patients, 83%, 88% and 87% completed week 52 in the placebo, baricitinib and adalimumab groups, respectively; rescue rates were 27%, 9% and 15%, respectively. ACR20 response at week 12 was higher for baricitinib versus placebo (p≤.001; Table 1). At weeks 12 and 24, significant improvements were seen for baricitinib versus placebo in ACR20/50/70 and DAS28, CDAI and SDAI low disease activity and remission rates, many by week one. Baricitinib was superior to adalimumab in ACR20 response rates at weeks 12, 24 and 52, and in DAS28-CRP≤3.2 at weeks 12 and 52. Change in mTSS at weeks 24 and 52 was significantly lower for baricitinib versus placebo (Table). At week 24, more baricitinib patients had improved physical function and reduced fatigue and pain versus placebo and adalimumab (Table). During weeks 0–24, more treatment-emergent AEs occurred with baricitinib and adalimumab versus placebo (71%, 67%, 60%); serious AE rates were 5%, 2% and 4%, respectively. By week 52, treatment-emergent AE rates for baricitinib versus adalimumab were 79% versus 77% and serious AE rates were 8% versus 4%; serious infection rates were similar across groups; three major cardiovascular events (2 baricitinib, 1 adalimumab), three deaths (2 baricitinib, 1 adalimumab), one tuberculosis case (adalimumab), and five malignancies (2 baricitinib, 3 placebo) were reported.
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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) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.015 | 0.003 |
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".