Efficacy and Safety of Subcutaneous Abatacept Plus Standard Treatment for Active Idiopathic Inflammatory Myopathy: Phase 3 Randomized Controlled Trial
Bibliographic record
Abstract
OBJECTIVE: Our objective was to evaluate the efficacy and safety of subcutaneous (SC) abatacept and standard of care (SOC) for the treatment of idiopathic inflammatory myopathy (IIM) over 52 weeks. METHODS: In this randomized, double-blind, placebo-controlled phase III trial, patients with treatment-refractory IIM received SC abatacept (at 125 mg weekly) with SOC (abatacept group) or a placebo with SOC (placebo group). A 24-week double-blind period was followed by an open-label period to assess outcomes from continued therapy with abatacept and initiation with abatacept (placebo-to-abatacept switch group) from 24 to 52 weeks. The primary end point was International Myositis Assessment and Clinical Studies definition of improvement (IMACS DOI) at week 24. Secondary efficacy and safety end points were assessed. RESULTS: Overall, 148 (double-blind) and 133 (open-label) patients were treated. Baseline demographics were well-balanced between treatment groups and disease subtypes. At 24 weeks, improvement per IMACS DOI was 56.0% for the abatacept group and 42.5% for the placebo group (P = 0.083); at 52 weeks, improvement was 69.8% (continued abatacept) and 69.0% (placebo-to-abatacept switch). The IMACS DOI rate at 24 weeks was greater in the nondermatomyositis (non-DM) group (abatacept: 57.1%; placebo: 32.3%; P = 0.040) than the DM group (abatacept: 55.0%; placebo: 50.0%; P = 0.679). The observed safety profile was similar in both groups. CONCLUSION: The proportion of patients who met improvement criteria after 24 weeks was similar between abatacept and placebo groups. However, analysis by IIM subtype suggested there may be a sustained benefit of SC abatacept for patients with non-DM subtypes.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.005 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".