Evidence map›Paper›PMID 35099555›Full record

ArticleInflammatory bowel diseases2022

INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial.

Julian Panés, Gerd Bouma, Marc Ferrante, Torsten Kucharzik, Maria Nachury, Fernando de la Portilla de Juan, Walter Reinisch, Francesco Selvaggi, Jörg Tschmelitsch, Neil R Brett and 6 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Inflammatory bowel diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 5 pooled it
10.5field-weighted citation impact, top 1% 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

27 citing papers in PubMed, 5 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Clinical Trial Endpoints for Perianal Fistulizing Crohn's Disease.The American journal of gastroenterology · 2026
    Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. Management and Treatment of Perianal Fistulizing Crohn's Disease.Clinical and experimental gastroenterology · 2025
    Review
  16. Article
  17. Article
  18. Challenges in IBD Research 2024: Novel Technologies.Inflammatory bowel diseases · 2024
    Review
  19. Review
  20. Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024
    Review
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

16 authors at 11 institutions in 11 countries.

Julian PanésInflammatory Bowel Disease Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.ORCID 0000-0002-4971-6902
Gerd BoumaAmsterdam Gastroenterology Endocrinology and Metabolism, Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, the Netherlands.
Marc FerranteDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.ORCID 0000-0003-1492-0716
Torsten KucharzikDepartment of Internal Medicine and Gastroenterology, University Teaching Hospital Lüneburg, University of Hamburg, Lüneburg, Germany.
Maria NachuryU1286 - INFINITE - Institute for Translational Research in Inflammation, Centre Hospitalier Universitaire de Lille, University of Lille, Lille, France.
Fernando de la Portilla de JuanDepartamento de Cirugia, Hospital Universitario Virgen del Rocío, University of Seville, Seville, Spain.
Walter ReinischDepartment for Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria.
Francesco SelvaggiUnit of Colorectal Surgery, Department of Medical, Surgical, Neurological, Metabolic and Ageing Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.
Jörg TschmelitschDepartment of Surgery, Hospital Barmherzige Brüder, Sankt Veit an der Glan, Austria.
Neil R BrettEvidera, Montréal, QC, Canada.
Martin LadouceurEvidera, Montréal, QC, Canada.
Matthias BinekTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Gary HantsbargerTakeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Sarah Campbell-HillTakeda UK Ltd, London, United Kingdom.
Chitra KarkiTakeda Pharmaceutical Company Limited, Cambridge, MA, USA.
Christianne BuskensAmsterdam Gastroenterology Endocrinology and Metabolism, Amsterdam UMC, Location AMC, University of Amsterdam, Amsterdam, the Netherlands.
Amsterdam University Medical Centers · NLTakeda (United States) · USHospital Clínic de Barcelona · ESHospital Universitario Virgen del Rocío · ESKU Leuven · BEMedical University of Vienna · ATTakeda (Switzerland) · CHTakeda (United Kingdom) · GBUniversität Hamburg · DEUniversité de Lille · FRUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of a single administration of darvadstrocel (expanded allogeneic adipose-derived mesenchymal stem cells) for treating complex perianal fistulas in patients with Crohn's disease was demonstrated in a randomized, double-blind trial (ADMIRE-CD [Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn\'s Disease] trial). The current chart review study (INSPECT [A retrospectIve chart review study evaluatINg the longer-term effectiveneSs of darvadstrocel in PatiEnts who CompleTed ADMIRE-CD]) evaluated the longer-term effectiveness and safety of darvadstrocel.

methodsEligible patients had completed at least 52 weeks in the ADMIRE-CD trial. Data on clinical remission and fistula relapse outcomes were collected retrospectively at 104 and 156 weeks after treatment. Adverse events of special interest (tumorigenicity and ectopic tissue formation) were collected up to 208 weeks after treatment.

resultsEighty-nine patients were included (43 darvadstrocel patients, 46 control subjects). At 52, 104, and 156 weeks posttreatment, clinical remission was observed in 29 (67.4%) of 43, 23 (53.5%) of 43, and 23 (53.5%) of 43 darvadstrocel-treated patients, compared with 24 (52.2%) of 46, 20 (43.5%) of 46, and 21 (45.7%) of 46 control subjects, respectively. In patients with clinical remission at week 52, this remission was sustained at 104 and 156 weeks after treatment in 19 (65.5%) of 29 and 16 (55.2%) of 29 darvadstrocel-treated patients and in 17 (70.8%) of 24 and 13 (54.2%) of 24 control subjects, respectively. Time to fistula relapse and incidence of fistula relapse or new fistula occurrence were not significantly different between groups. Tumorigenicity was reported for 1 (2.2%) patient in the control group (malignant epidermoid carcinoma). No ectopic tissue formation was reported.

conclusionsReal-world follow-up of patients from the ADMIRE-CD trial indicates that clinical remission of complex perianal fistulas can be sustained in the long term irrespective of whether it is achieved through darvadstrocel administration or maintenance treatment regimens and confirms a favorable long-term safety profile of darvadstrocel.

Indexed as

Crohn DiseaseCutaneous FistulaMesenchymal Stem Cell TransplantationRectal FistulaHumansNeoplasm Recurrence, LocalRetrospective StudiesTreatment Outcomefistula remissionperianal fistulizing Crohn’s diseasestem cell therapy

Identifiers

PMID35099555
PMCPMC9629463
OpenAlexW4210804984

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.