S1145 Clinical Effectiveness and Safety of Vedolizumab in Patients With Crohn’s Disease in China: Results From a Real World Study
Bibliographic record
Abstract
Introduction: Vedolizumab (VDZ) is a gut-selective antilymphocyte trafficking humanized monoclonal antibody that has demonstrated efficacy and safety for the treatment of moderate-to-severe Crohn’s Disease (CD) in global clinical trials. VDZ was conditionally approved in 2020 in China for the treatment of moderate to severe CD. The goal of this study was to evaluate the real-world clinical effectiveness and safety of VDZ in patients (pts) with CD in China. Methods: This was a multi-center, observational, retrospective medical chart review study in adult pts (≥18 years old) with active CD in China who initiated VDZ as any line of biologic treatment. Data were collected from VDZ treatment initiation to chart abstraction, treatment discontinuation, death, or loss to follow-up. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were estimated using the Kaplan Meier method over 6, 18, and 30 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations, and CD-related hospitalization and surgeries were also evaluated. Baseline demographic and clinical characteristics data were also collected. Results: In total, 131 Crohn’s disease pts who were treated with VDZ were included in the study. Baseline characteristics are shown in Table 1. Over 30 months, cumulative rates of clinical response and clinical remission were 69.6% and 46.8%, respectively and rates of mucosal healing and deep remission were 76.0% and 56.3%, respectively. The cumulative rate of treatment persistence over 30 months was 42.4%. The incidence rates per 100 patient-years was 4.73 (95% CI: 2.36, 9.45) for serious adverse events and 0.58 (95% CI: 0.08, 4.12) for serious infections. Incidence rates per 100 patient years for other outcomes were as follows: CD exacerbations 8.71 (95% CI: 5.16, 14.71), CD-related emergency department visits 1.17 (95% CI: 0.29, 4.66), and CD-related surgeries 5.49 (95% CI: 2.86, 10.55). Conclusion: VDZ is an effective and safe longer-term treatment in patients with CD in China. Results from this real-world study were consistent with results from previous global studies, supporting the effectiveness and safety of VDZ treatment across global regions. Acknowledgements: Medical writing support was provided by Paul Hassan, PhD, of Excel Scientific Solutions, and funded by Takeda. Table 1. - Baseline characteristics Baseline Characteristics VDZN=131 Age (years), mean ± SD 35.2±12.6 Male, n (%) 80 (61.1) Disease duration (years), mean ± SD 4.2(±4.2) CD location Colonic with/without upper GI disease, n (%) 21 (16.0) Ileal with/without upper GI disease, n (%) 16 (12.2) Ileocolonic with/without upper GI disease, n (%) 68 (51.9) Disease behavior Non-stricturing, non-penetrating, n (%) 36 (27.5) Stricturing, n (%) 45 (34.4) Penetrating, n (%) 23 (17.6) Disease severity Normal, n (%) 8 (6.1) Mild, n (%) 48 (36.6) Moderate, n (%) 43 (32.8) Severe, n (%) 8 (6.1) Active fistula* prior to index VDZ treatment initiation Yes, n (%) 54 (41.2) Prior CD-related surgeries before index VDZ treatment initiation Yes, n (%) 27 (20.6) CD-related hospitalizations 12 months before index VDZ treatment initiation** 77 (58.8) Prior non-biologic therapy before index VDZ treatment initiation 66 (50.4) Prior biologic therapy before index VDZ treatment initiation 53 (40.5) *Includes enterocutaneous, perianal, rectovaginal, other, and unknown.**Includes majority hospital visits to evaluate the CD signs and symptoms (97[71.3%]), acute CD flares (15 [11%]), surgery (10[7.4%]), among 136 hospital visits by 77 patients.CD, Crohn's disease; GI, gastrointestinal; Std Diff, standardized difference; VDZ, vedolizumab.
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 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| 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".