Evidence map›Paper›PMID 38137726›Full record

ArticleJournal of clinical medicine2023

Switching Vedolizumab from IV to SC Injection in Inflammatory Bowel Disease Patients with Active Disease: Real-World Experience from a German IBD Cohort.

Alica Kubesch, Nina Kruse, Florian Jungheim, Ümniye Balaban, Katharina Stratmann, Kathrin Sprinzl, Antje Dienethal, Thomas Krause, Stefan Zeuzem, Irina Blumenstein

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Alica KubeschGoethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany.
Nina KruseGoethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany.
Florian JungheimGoethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany.
Ümniye BalabanInstitute of Biostatistics and Mathematical Modeling, University Hospital, Goethe University, 60596 Frankfurt a.M., Germany.
Katharina StratmannGoethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany.
Kathrin SprinzlGoethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany.
Antje DienethalGoethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany.
Thomas KrauseGastroenterologie Opernstrasse, 34117 Kassel, Germany.
Stefan ZeuzemGoethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany.
Irina BlumensteinGoethe University Frankfurt, University Hospital, Medical Clinic 1, 60596 Frankfurt a.M., Germany.
Goethe University Frankfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVedolizumab (VDZ) for subcutaneous (SC) injection was approved for use in Europe in 2020 and the US in 2023. Promising efficacy and tolerability have been proven in pivotal trials. However, real-world data on the SC use of VDZ, especially in patients with active disease, are still lacking. We aimed to determine treatment persistence and the drug's efficacy in inflammatory bowel disease (IBD) patients with active disease in comparison to patients in clinical remission.

methodsPatients treated for IBD in a tertiary care center from July 2020 to December 2021 were included in this study. Clinical and biochemical parameters and data on treatment adherence were collected. VDZ trough levels and disease activity before and after the switch from intravenous (IV) to SC injections were monitored during routine checkups and were retrospectively analyzed. The patients were followed up until week 20.

resultsEighty-two patients were included in the study. Of them, 35 patients had active disease (35/82 = 43%) at the time of the switch and 47 patients (47/82 = 57%) were in remission. In total, 10 patients experienced switch failure, 5 were switched back to IV VDZ, and 5 were swapped to a different biologic agent. We observed an increase in VDZ trough levels from the switch to week 8 and from the switch to week 20 in the remission group. Vedolizumab trough levels of 7.4, 51.4, and 33.45 ug/mL at the switch, week 8, and week 20 were identified to discriminate between remission and disease activity in our cohort. There was no new safety signal detected during the study period.

conclusionsThe switch from IV to SC VDZ proved to be efficient, safe, and even capable of reducing residual disease activity.

Indexed as

biologicsCrohn’s diseaseIBDreal-world datasub-cutaneous applicationtrough levelsulcerative colitisvedolizumab

Identifiers

PMID38137726
PMCPMC10743496
OpenAlexW4389686496

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.