Evidence map›Paper›PMID 28961803›Full record

Trial reportJournal of Crohn's & colitis2018

Anti-MAdCAM Antibody Increases ß7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn's Disease.

Mina Hassan-Zahraee, Anindita Banerjee, John B Cheng, Weidong Zhang, Alaa Ahmad, Karen Page, David von Schack, Baohong Zhang, Steven W Martin, Satyaprakash Nayak and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.1field-weighted citation impact, top 24% 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

11 citing papers in PubMed, 26 citations in OpenAlex.

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  11. Total flavone ofWorld journal of gastroenterology · 2018
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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

19 authors at 1 institution in 1 country.

Mina Hassan-ZahraeePfizer Inc., Cambridge, MA, USA.
Anindita BanerjeePfizer Inc., Cambridge, MA, USA.
John B ChengPfizer Inc., Cambridge, MA, USA.
Weidong ZhangPfizer Inc., Cambridge, MA, USA.
Alaa AhmadPfizer Inc., Cambridge, MA, USA.
Karen PagePfizer Inc., Cambridge, MA, USA.
David von SchackPfizer Inc., Cambridge, MA, USA.
Baohong ZhangPfizer Inc., Cambridge, MA, USA.
Steven W MartinPfizer Inc., Cambridge, MA, USA.
Satyaprakash NayakPfizer Inc., Cambridge, MA, USA.
Padma ReddyPfizer Inc., Cambridge, MA, USA.
Li XiPfizer Inc., Cambridge, MA, USA.
Hendrik NeubertPfizer Inc., Andover, MA, USA.
Mireia Fernandez OcanaPfizer Inc., Andover, MA, USA.
Ken GorelickPfizer Inc., Cambridge, MA, USA.
Robert ClarePfizer Inc., Cambridge, MA, USA.
Michael VincentPfizer Inc., Cambridge, MA, USA.
Fabio CataldiPfizer Inc., Cambridge, MA, USA.
Kenneth HungPfizer Inc., Cambridge, MA, USA.
Pfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo define pharmacodynamic biomarkers in the peripheral blood of patients with Crohn's disease [CD] after treatment with PF-00547659, an anti-human mucosal addressin cell adhesion molecule-1 [MAdCAM-1] monoclonal antibody.

methodsIn this Phase 2, randomised, double-blind, controlled study [OPERA], blood samples were analysed from patients with moderate to severe active CD who received placebo or 22.5 mg, 75 mg, or 225 mg of PF-00547659 subcutaneously at baseline and at Weeks 4 and 8, with follow-up at Week 12. Soluble MAdCAM [sMAdCAM] was measured by mass spectrometry, β7-expressing T cells by flow cytometry, and gene transcriptome by RNA sequencing.

resultsA slight increase in sMAdCAM was measured in the placebo group from baseline to Week 12 [6%], compared with significant decreases in all PF-00547659 groups [-87% to -98%]. A slight increase from baseline to Week 12 was observed in frequency and molecules of equivalent soluble fluorochrome for β7+ central memory T cells in the placebo group [4%], versus statistically significant increases in the active treatment groups [48% to 81%]. Similar trends were seen for β7+ effector memory T cells [placebo, 8%; PF-00547659, 84-138%] and β7+ naïve T cells [8%; 13-50%]. CCR9 gene expression had statistically significant up-regulation [p = 1.09e-06; false discovery rate < 0.1] with PF-00547659 treatment, and was associated with an increase in β7+ T cells.

conclusionsResults of the OPERA study demonstrate positive pharmacology and dose-dependent changes in pharmacodynamic biomarker measurements in blood, including changes in cellular composition of lymphocytes and corresponding CCR9 gene expression changes.

Indexed as

T-LymphocytesAdultAntibodies, Monoclonal, HumanizedBiomarkersCell Adhesion MoleculesC-Reactive ProteinCrohn DiseaseDouble-Blind MethodFecesFemaleHumansImmunoglobulinsIntegrin beta ChainsLeukocyte L1 Antigen ComplexLymphocyte CountMaleAntibodies, Monoclonal, HumanizedBiomarkersCC chemokine receptor 9Cell Adhesion MoleculesC-Reactive ProteinImmunoglobulinsintegrin beta7Integrin beta ChainsLeukocyte L1 Antigen ComplexMADCAM1 protein, humanMucoproteinsontamalimabReceptors, CCRCrohn’s diseaseMAdCAMPF-00547659pharmacodynamicstreatment

Identifiers

PMID28961803
PMCPMC5881777
OpenAlexW2753148232

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.