Sustained Steroid Free Remission at One Year in Corticosteroid Dependent Ulcerative Colitis Patients on Vedolizumab
Bibliographic record
Abstract
Introduction: Vedolizumab (VDZ) is a monoclonal antibody directed against the integrin heterodimer a4β7 which has been shown to be effective in the induction and maintenance of remission in patients with ulcerative colitis (UC). Limited data exists in the management of steroid dependent UC. The objective of this study is to determine the efficacy of VDZ with steroid dependent UC patients in a real-word setting. Methods: We conducted a tertiary care, single center, retrospective study from May of 2015 to March of 2018 evaluating response to vedolizumab in patients with steroid dependent UC. Patients with at least 12 months of follow-up regardless of outcome, were included.The primary outcome was sustained steroid free clinical remission at 12 months (SSFR) defined as being steroid free and in clinical remission at 3, 6 and 12 months time points. Clinical remission was defined as partial Mayo score less than 2 or a physician's global assessment of being in clinical remission. Secondary outcomes were steroid free clinical remission specifically at 3, 6 and 12 months and VDZ cessation rate. Results: Fifty-two patients met inclusion criteria. The median follow-up was 79.3 (58.1-109.1) weeks. Median age was 38 (30-55.3) years. 64% (33/52) had prior anti-TNF exposure. Baseline median fecal calprotectin was 672 (344-853) ug/g and median CRP 4.4 (2.0-17.0). VDZ was dose escalated to every 4 weeks in 46.1% (24/52) at a median time of 34.6 (21.0-54.4) weeks. Sustained steroid free remission at 12 months was achieved by 36.5% (19/52) of patients. Proportion of steroid free clinical remission at 3 months was 50% (26/52), at 6 months 57.7% (30/52), and at 12 months 55.8% (29/52). SSFR was attained in 36.4% (12/33) of those who had prior anti-TNF exposure and in 36.8% (7/19) with no prior anti-TNF exposure. Prior anti-TNF exposure, gender, age and disease duration were not associated with SSFR in this cohort. By the end of the follow up period, 28.8% (15/52) discontinued therapy; 13 were due to lack of effect of whom 5 required colectomy, 1 due to patient preference and 1 loss to follow up. Median time to colectomy was 35.9 (17.8-72.9) weeks. Conclusion: In UC patients who are steroid dependent, VDZ is able to achieve sustained steroid free remission at one year in approximately one third of patients. Further studies are required to delineate independent predictors of SSFR.
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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 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".