P676 Correlation of lipid levels with reduction in inflammation in patients with ulcerative colitis: Data from the tofacitinib OCTAVE clinical trials
Bibliographic record
Abstract
Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Mild lipid elevations—with no evidence suggesting correlation with major cardiovascular events—have been seen in tofacitinib-treated patients (patients).1,2 We evaluated relationships between inflammatory status and lipid levels in tofacitinib-treated patients with UC. This analysis included patients from two randomised, placebo-controlled tofacitinib induction trials in patients with moderate-to-severe UC (OCTAVE Induction 1 and 2, NCT01465763 and NCT01458951). Correlation of Week 8 changes from baseline in lipid parameters (low- and high-density lipoprotein cholesterol [LDL; HDL], and total cholesterol [TC]) with Week 8 changes from baseline in C-reactive protein (CRP), and with the proportions of patients with mucosal healing (Mayo endoscopic subscore ≤1) and remission (total Mayo score ≤2, no individual subscore >1 and rectal bleeding subscore = 0) at Week 8, were determined. In OCTAVE Induction 1 and 2, 234 patients received placebo and 905 received tofacitinib 10 mg twice daily (BID). Consistent with previously reported data,2 there were greater increases from baseline in lipid levels, decreases from baseline in CRP, and greater rates of mucosal healing and remission at Week 8 with tofacitinib 10 mg BID vs. placebo (Table). The Pearson correlation coefficients at Week 8 between CRP and LDL, HDL and TC levels were significantly different from zero for both placebo-treated (LDL: −0.23; HDL: −0.34; TC: −0.36) and tofacitinib-treated patients (LDL: −0.19; HDL: −0.25; TC: −0.27). For tofacitinib-treated patients, correlation coefficients at Week 8 between mucosal healing and HDL (0.12) and TC (0.09), and between remission and HDL (0.08), were significantly different from zero. There was significant negative but small correlation between lipid and CRP changes in the tofacitinib and placebo groups. These data suggest that lipid changes seen in patients treated with tofacitinib may be partially due to the beneficial effect of reduced inflammation. More studies are warranted to better understand these correlations. 1. Charles-Schoeman C et al. Cardiovascular safety findings in patients with rheumatoid arthritis treated with tofacitinib, an oral Janus kinase inhibitor. Semin Arthritis Rheum, 2016;46:261–71. 2. Sandborn WJ, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med, 2017;376:1723–36.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".