Evidence map›Paper›PMID 40711738›Full record

ArticleDigestive diseases and sciences2025

Clinical, Radiological and Pharmacokinetic Data of CT-P13 Subcutaneous in Individuals with Fistulizing Anoperineal Crohn's Disease.

N Fathallah, M Draullette, J Kirchgesner, S Paul, X Roblin, A Bourrier, M A Haouari, E Chambenois, S Morisset, P Seksik and 1 more

Abstract read
In one paragraph

Article in Digestive diseases and sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. 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

11 authors.

N FathallahDepartment of Medical and Surgical Proctology, Hôpital Paris Saint-Joseph, 185, Rue Raymond Losserand, 75014, Paris, France. drnadia.fathallah@gmail.com.
M DraulletteDepartment of Gastroenterology, Hôpital Saint-Antoine, 184, Rue du Faubourg Saint-Antoine, 75012, Paris, France.
J KirchgesnerDepartment of Gastroenterology, Hôpital Saint-Antoine, 184, Rue du Faubourg Saint-Antoine, 75012, Paris, France.
S PaulDepartment of Immunology, CHU Saint-Etienne, Avenue Albert Raimond, 42270, Saint-Priest-en-Jarez, France.
X RoblinService de Gastroentérologie CHU Saint-Etienne, Avenue Albert Raimond, 42270, Saint-Priest-en-Jarez, France.
A BourrierDepartment of Gastroenterology, Hôpital Saint-Antoine, 184, Rue du Faubourg Saint-Antoine, 75012, Paris, France.
M A HaouariDepartment of Radiology, Hôpital Paris Saint-Joseph, 185, Rue Raymond Losserand, 75014, Paris, France.
E ChambenoisDepartment of Radiology, Hôpital Saint-Antoine, 184, Rue du Faubourg Saint-Antoine, 75012, Paris, France.
S MorissetBiostatistics Consultant, Pérouges, France.
P SeksikDepartment of Gastroenterology, Hôpital Saint-Antoine, 184, Rue du Faubourg Saint-Antoine, 75012, Paris, France.
V de ParadesDepartment of Medical and Surgical Proctology, Hôpital Paris Saint-Joseph, 185, Rue Raymond Losserand, 75014, Paris, France.

Funding

Celltrion Healthcare CHUSE 24EX237
6 · The paper itself

Abstract

purposeThe aim of this study was to evaluate the clinico-radiological remission rate in patients with fistulizing anoperineal lesions of Crohn's disease treated with CT-P13 SC, as well as pharmacokinetic data and treatment persistence rate.

methodsWe included all consecutive patients seen in the dedicated proctology outpatient clinic between June 1st and July 15th, 2024, for fistulizing anoperineal lesions and treated for at least 3 months with CT-P13 SC. Clinical, radiological and pharmacokinetic data were collected.

resultsData from 39 patients were analyzed. The median duration of treatment was 16.1 months. Seventeen patients (43.6%) had initiated SC formulation upfront. The complete clinical remission rate was 74.4%, significantly higher in patients switched from IV to SC formulation. Among patients switched from IV to SC formulation, 86.5% maintained remission. In the overall study population, 89.7% were able to continue treatment, with intensified protocols in 61.5% of patients. The deep radiological remission rate was 61.5%. The median infliximab concentration was 22.7 µg/mL. Only the intensified administration protocol was significantly associated with higher infliximab concentrations. Immunosuppressants had no impact. The median infliximab concentration was higher in patients in remission (35.9 µg/mL vs 22.4 µg/mL), but without any significant difference.

conclusionCT-P13 SC appears to be at least as effective as the IV formulation for fistulizing anoperineal lesions, and switching from IV to SC allows remission to be maintained in the vast majority of cases. Despite numerically higher infliximab concentrations in patients in remission, no significant difference could be identified. Trial registration number and date: Registration with the ethics committee on 11/14/2023.

Indexed as

Crohn DiseaseDiatrizoate MeglumineGastrointestinal AgentsInfliximabRectal FistulaAdultAntibodies, MonoclonalFemaleHumansInjections, SubcutaneousMaleMiddle AgedPerineumRemission InductionRetrospective StudiesTreatment OutcomeAntibodies, MonoclonalCT-P13Diatrizoate MeglumineGastrointestinal AgentsInfliximabAnal fistulasAnoperineal lesionsCrohn’s diseaseCT-P13 SCInfliximab

Identifiers

PMID40711738
PMCPMC12531304

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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.