Evidence map›Paper›PMID 32677804›Full record

Observational studyClinical and translational gastroenterology2020

Fecal Calprotectin Predicts Mucosal Healing in Patients With Ulcerative Colitis Treated With Biological Therapies: A Prospective Study.

Lorenzo Bertani, Corrado Blandizzi, Maria Gloria Mumolo, Linda Ceccarelli, Eleonora Albano, Gherardo Tapete, Giovanni Baiano Svizzero, Federico Zanzi, Francesca Coppini, Nicola de Bortoli and 4 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in Clinical and translational gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04818788 (Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy), which is not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
6.1field-weighted citation impact, top 3% 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.

NCT04818788 unknown statusnot on this mapstarted 2021, after this paper: background citation

Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy

TypeobservationalSponsorAssiut UniversityRan2021 to 2022Enrolled24ConditionsUlcerative ColitisArmsBiological Drug
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Pooled it
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  3. Evaluation of Mucosal Healing in Ulcerative Colitis by Fecal Calprotectin vs. Fecal Immunochemical Test: A Systematic Review and Meta-analysis.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2023
    Pooled it
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  6. LIAISONUnited European gastroenterology journal · 2022
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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

14 authors at 1 institution in 1 country.

Lorenzo BertaniDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Corrado BlandizziDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Maria Gloria MumoloIBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, Pisa, Italy.
Linda CeccarelliIBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, Pisa, Italy.
Eleonora AlbanoDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Gherardo TapeteDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Giovanni Baiano SvizzeroDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Federico ZanziDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Francesca CoppiniDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Nicola de BortoliDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Massimo BelliniDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Riccardo MorgantiSection of Statistics, Pisa University Hospital, Pisa, Italy.
Santino MarchiDepartment of Translational Research and New Tecnologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
Francesco CostaIBD Unit, Department of General Surgery and Gastroenterology, Pisa University Hospital, Pisa, Italy.
University of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBiological therapies are widely used for the treatment of ulcerative colitis. However, only a low proportion of patients achieve clinical remission and even less mucosal healing. There is currently scarce knowledge about the early markers of therapeutic response, with particular regard to mucosal healing. The aim of this prospective study was to evaluate the role of fecal calprotectin (FC) as early predictor of mucosal healing.

methodsA prospective observational study was conducted on patients with ulcerative colitis, who started biological therapy with infliximab, adalimumab, golimumab, or vedolizumab at our center. All patients underwent colonoscopy, performed by 2 blinded operators, at baseline and week 54 or in case of therapy discontinuation because of loss of response. FC was assessed at baseline and week 8 and evaluated as putative predictor of mucosal healing at week 54.

resultsWe enrolled 109 patients, and 97 were included in the analysis. Twenty-six patients (27%) experienced loss of response. Over 71 patients (73%) with clinical response at week 54, clinical remission was obtained in 60 patients (61.9%) and mucosal healing in 45 patients (46.4%). After 8 weeks of treatment, FC predicted mucosal healing at week 54 (P < 0.0001). Sensitivity, specificity, positive predictive value, and negative predictive value were estimated to be 75%, 88.9%, 86.6%, and 75.5%, respectively, based on a cutoff of 157.5 mg/kg. DISCUSSION: The present study suggests that FC assessment after 8 weeks of treatment with all the biological drugs could represent a promising early marker of response to therapy in terms of mucosal healing.

Indexed as

AdultBiological ProductsBiomarkersColitis, UlcerativeColonColonoscopyDrug Administration ScheduleFeasibility StudiesFecesFemaleHumansIleumImmunologic FactorsIntestinal MucosaLeukocyte L1 Antigen ComplexMaleBiological ProductsBiomarkersImmunologic FactorsLeukocyte L1 Antigen Complex

Identifiers

PMID32677804
PMCPMC7263645
OpenAlexW3027635284

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.