A145 “REAL WORLD” SAFETY AND EFFECTIVENESS OF VEDOLIZUMAB FOR ULCERATIVE COLITIS: RETROSPECTIVE STUDY FROM A TERTIARY CARE CANADIAN CENTRE
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
Vedolizumab (VDZ), a humanized monoclonal antibody which targets the α4β7 integrin and prevents homing of lymphocytes to the gut, was approved by Health Canada in 2015 for treatment of moderate to severe ulcerative colitis (UC). Its gut selective mode of action offers potential for a lower risk of systemic infection while achieving similar or greater efficacy compared to conventional treatments. To assess clinical response and safety of VDZ. Retrospective cohort study from a tertiary care Canadian centre between May 2015 to August 2016. Adult patients with UC treated with VDZ, with follow-up after initiation of therapy, were eligible. Patients were identified through infusion center listings and data abstracted from electronic medical records, review of clinic records, endoscopy reports and infusion centre reports. Clinical response - defined as normalization of stool frequency and absence of rectal bleeding, as well as physician global assessment, and serious adverse events were assessed. Patients were eligible for safety analysis as long as at least one dose was received. Eighty-eight patients were included, with a median age of 47 years (range 18–85), 58% (51/88) male, 53% (47/88) tumor necrosis factor (TNF)-antagonist exposed with a median follow up of 17 weeks (range 0–61 weeks). The median disease duration was 7 years (range 0–46), 61% (54/88) had a history of disease extension beyond the splenic flexure and 23% (20/88) had a history or prior/active smoking. Patients received a median of 5 VDZ doses (range 1–13) and 47% (41/88) were receiving concomitant treatment with prednisone at the initiation of VDZ. 51% (29/57) of patients achieved clinical response by the end of their induction period (week 6) and 56% (20/36) achieved clinical response at 6 months and 64% (44/69) of patients overall achieved clinical response at some point during the study period. 24 patients underwent endoscopic evaluation after starting VDZ of which 7/24 patients (29%) were reported to have mucosal healing or improved mucosa. No infusion reactions were reported. In 7% (6/88) of patients there were reports of an infection which required antibiotics, of which four had an upper respiratory tract infection and only one patient was admitted for treatment of pneumonia. One patient discontinued VDZ secondary to arthralgia and lethargy after their initial dose. VDZ is a safe and effective treatment for UC in routine clinical practice. In this study, clinical response after induction was achieved in over half of patients by week 6 and close to 2/3 overall achieved clinical remission. Only one patient discontinued treatment due to reports of arthralgia and lethargy after the infusion. None
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.
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 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| 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 it