A133 EFFECTIVENESS AND SAFETY OF VEDOLIZUMAB INDUCTION THERAPY IN PATIENTS WITH ULCERATIVE COLITIS: REAL-WORLD EXPERIENCE IN A TERTIARY IBD CENTRE
Bibliographic record
Abstract
Vedolizumab (VDZ) is a humanized monoclonal IgG1 antibody which inhibits leukocyte vascular adhesion and migration into the gastrointestinal tract through α4β7 integrin blockade. This agent became available in Canada in mid-2015 for the treatment of moderate to severe ulcerative colitis (UC). To investigate the real-world efficacy and safety of vedolizumab (VDZ) as induction therapy in UC patients at a tertiary IBD centre and to examine predictors of remission. Demographic and clinical data for UC patients treated with 300mg VDZ infusions at weeks 0, 2, 6 and 14 was gathered retrospectively. Clinical remission (CR, partial Mayo score≤2) and steroid-free clinical remission (SFCR) after the first 3 infusions (induction phase) between weeks 8–12 were the primary endpoints. Secondary endpoints were CR and SFCR after 4 infusions (1st maintenance infusion) between weeks 16–20. Adverse events were also recorded. Data from 68 UC patients (63% male, median age 33 years, median disease duration 6 years, median pMayo 7) were analyzed. Anti-TNF naive were 31% and 69% had pancolitis. At the time of first infusion, 49% were on systemic steroids and 20% on an immunomodulator, while 44% patients were started on VDZ monotherapy. Median partial Mayo scores and median CRP levels improved significantly after 3 and 4 VDZ infusions compared to baseline (p<0.05). After 3 infusions (n=68), 37% and 31% of the patients achieved CR and SFCR respectively. After 4 infusions (n=53), 36% and 32% of the patients were in CR and SFCR respectively. Seventy percent of the non-responders after the 3rd infusion remained non-responders after the 4th infusion. Baseline characteristics including disease duration less than 5 years, no prior anti-TNF exposure, immunomodulator concurrent treatment, mild disease (p=0.025) and CRP less than 5mg/L (p=0.004) were associated with clinical remission after the first 3 infusions. Clinical remission after 3 VDZ infusions was significantly associated with sustained clinical remission after 4 infusions (p<0.001). Overall, 12% discontinued VDZ due to no response and 7% underwent elective proctocolectomy. There were no infusion reactions or serious side effects. The most common side effect was headache (7%). VDZ is an effective, safe and well tolerated treatment option in refractory UC patients. Clinical remission and steroid-free clinical remission can be achieved in 1/3 of the patients after the induction phase. This real life series in a tertiary care centre demonstrates similar efficacy results as the other real-world clinical studies. Assessment of VDZ response after the 3rd infusion could be critical to determine treatment benefits and decide further management. Baseline characteristics and vedolizumab treatment outcomes in UC patients None
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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 | 0.000 | 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".