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Record W4414625148 · doi:10.17235/reed.2025.11525/2025

Multicenter Spanish study on vedolizumab intravenous to subcutaneous switch in patients with inflammatory bowel disease in clinical remission

2025· article· en· W4414625148 on OpenAlexaboutno aff
Beatriz Gros, Noemí Manceñido, J M Benítez, Jordi Guardiola, Inmaculada Alonso Abreu, Iago Rodríguez–Lago, Rubén Alvarado, Ángel Ponferrada, Federico Argüelles‐Arias, G E Rodríguez, Iván Guerra, Marisa Iborra, Pere Antoni Borràs, Fiorella Cañete, Lucía Madero Velázquez, Jesús Castro Poceiro, Antonio M. Caballero‐Mateos, Manuel Barreiro‐de Acosta, José María Huguet, Beatriz Castro Senosain, Francisco López Romero-Salazar, Berta Caballol, Carles Suria, Erika Alfambra, Laura García, Judit Orobitg, S Marín Pedrosa, Pilar Soto Escribano, Yamile Zabana, Ana Gutiérrez, Eva Iglesias Flores

Bibliographic record

VenueRevista Española de Enfermedades Digestivas · 2025
Typearticle
Languageen
FieldBiochemistry, Genetics and Molecular Biology
TopicInflammatory Bowel Disease
Canadian institutionsnot available
Fundersnot available
KeywordsVedolizumabInflammatory bowel diseaseUlcerative colitisCrohn's diseaseMulticenter studyClinical trialComplete remission

Abstract

fetched live from OpenAlex

BACKGROUND AND AIMS: despite the established use of intravenous (IV) vedolizumab to treat inflammatory bowel disease, there is growing interest in exploring the advantages of the novel subcutaneous (SC) route. However, comprehensive real-world evidence regarding the extended safety and effectiveness remain scarce. METHODS: inflammatory bowel diseases (IBD) patients on IV vedolizumab treatment in clinical remission from 24 Spanish hospitals were given the option to transition to SC injections (where this formulation was available) or to remain on IV, whereas patients from centers without access to SC vedolizumab remained on IV therapy. Data encompassing clinical disease activity, biochemical markers, adverse events, treatment persistence, and disease-related outcomes were retrospectively gathered from prospectively maintained clinical records at baseline, and at weeks 12, 24, and 48. RESULTS: a total of 207 patients were identified and 23 were excluded as they were not in clinical remission, resulting in a final total of 184 patients included in the study. Of these, 53 (28.8 %) remained on IV vedolizumab, while 131 (71.2 %) transitioned to SC. There were 108 (58.7 %) patients with ulcerative colitis and 76 (41.3 %) with Crohn's disease. Both groups had comparable demographic characteristics, except for Crohn's disease behavior, with non-inflammatory non-stricturing pattern (B1 Montreal classification) being predominant among patients who transitioned to SC (p = 0.023). No differences were observed in drug persistence (log rank test p = 0.82). Clinical, biochemical and fecal calprotectin remission at the different time-points were comparable at each time point with the exception of clinical remission at week 12, favoring SC over IV. Drug intensification occurred in 24.5 % of patients on IV versus none on SC, p < 0.0001. Safety was consistent with that previously reported, and there were no differences between the groups (13 [8 %] SC vs 1 [2.1 %] IV, p = 0.059), most being mild in nature. CONCLUSIONS: transitioning from IV to SC vedolizumab in patients with IBD in remission showed a comparable effectiveness to maintain disease remission and persistence. Patients on IV are more likely to require drug intensification during follow-up.

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 distilled prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.011
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

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.

Opus teacher head0.007
GPT teacher head0.282
Teacher spread0.275 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designObservational
Domainnot available
GenreEmpirical

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".

Quick stats

Citations0
Published2025
Admission routes1
Has abstractyes

Explore more

Same venueRevista Española de Enfermedades DigestivasSame topicInflammatory Bowel DiseaseFrench-language works237,207