P627 Real-world clinical effectiveness and safety of vedolizumab and ustekinumab in biologic-naïve patients with Crohn’s disease by disease location: Results from the EVOLVE Expansion study
Bibliographic record
Abstract
Abstract Background Crohn’s disease (CD) location may affect disease course and treatment (Tx) decisions. This analysis compared real-world clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in biologic-naïve patients (pts) by CD location. Methods Medical charts of biologic-naïve pts with CD aged ≥18 years initiating VDZ or UST in Australia, Belgium or Switzerland from 2016 to 2021 were analysed in a multicentre, observational, retrospective EVOLVE Expansion study (NCT05056441). Subgroup analysis evaluated outcomes with VDZ vs UST in pts with baseline ileal, ileocolonic and colonic CD (Montreal classification). Data were collected from Tx initiation to the first of chart abstraction initiation, Tx discontinuation, loss to follow-up or death. Inverse probability of Tx weighting (IPTW) was used to balance baseline characteristics between cohorts. Clinical outcomes (clinical response, clinical remission, mucosal healing), as assessed using published algorithms,1 and Tx persistence during 36 Tx months were analysed in time-to-event analyses (Kaplan-Meier method). Risks of safety (serious adverse events [SAEs], serious infections [SIs]) and healthcare resource utilisation (HCRU; CD exacerbations, CD-related hospitalisations, CD-related surgeries) outcomes with VDZ vs UST during 36 months were also compared. Results This analysis included 293 pts with ileal (VDZ:158, UST:135), 185 with ileocolonic (VDZ:91, UST:94) and 121 with colonic (VDZ:84, UST:37) CD. Baseline characteristics after IPTW were similar between VDZ and UST cohorts in all 3 subgroups. Cumulative rates during 36 Tx months were similar between VDZ and UST cohorts in ileal, ileocolonic and colonic CD subgroups for clinical response (p=0.67, p=0.94, p=0.22, respectively), clinical remission (p=0.51, p=0.20, p=0.52), mucosal healing (p=0.29, p=0.60, p=0.71) and Tx persistence (p=0.37, p=0.29, p=0.50) (Figure). There were no differences in the risks of SAEs, SIs, CD exacerbations and CD-related hospitalisations between cohorts across disease location; risk of CD-related surgeries was similar in pts with ileocolonic and colonic CD, and higher in VDZ vs UST cohort (p=0.02) in pts with ileal CD (Table). However, in ileal CD subgroup, CD-related surgeries during 36 months were reported only in 12/158 (7.6%) pts in VDZ and 3/135 (2.2%) pts in UST cohort. Conclusion During 36 Tx months, effectiveness, safety and HCRU outcomes were similar between VDZ and UST cohorts regardless of baseline disease location; risk of CD-related surgeries was higher with VDZ vs UST in pts with ileal CD and similar between cohorts in other subgroups. However, the absolute number of pts requiring CD-related surgeries was low. Reference: 1. Bressler B, et al. J Crohns Colitis. 2021;15(10):1694-1706.
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 | 0.003 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| 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".