Evidence map›Paper›PMID 29761166›Full record

ArticleHepatology communications2018

NI-0801, an anti-chemokine (C-X-C motif) ligand 10 antibody, in patients with primary biliary cholangitis and an incomplete response to ursodeoxycholic acid.

Kathy L de Graaf, Geneviève Lapeyre, Florence Guilhot, Walter Ferlin, Stuart M Curbishley, Marco Carbone, Paul Richardson, Sulleman Moreea, C Anne McCune, Stephen D Ryder and 6 more

Open access · goldAbstract read
In one paragraph

Article in Hepatology communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
3.0field-weighted citation impact, top 7% 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

18 citing papers in PubMed, 45 citations in OpenAlex.

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  14. Regulation and functional roles of chemokines in liver diseases.Nature reviews. Gastroenterology & hepatology · 2021
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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

16 authors at 8 institutions in 3 countries.

Kathy L de GraafNovimmune SA Plan-les-Ouates Switzerland.ORCID 0000-0003-0297-5189
Geneviève LapeyreNovimmune SA Plan-les-Ouates Switzerland.
Florence GuilhotNovimmune SA Plan-les-Ouates Switzerland.
Walter FerlinNovimmune SA Plan-les-Ouates Switzerland.
Stuart M CurbishleyCentre for Liver Research University of Birmingham Birmingham United Kingdom.
Marco CarboneDivision of Gastroenterology and Program for Autoimmune Liver Diseases, International Center for Digestive Health, Department of Medicine and Surgery University of Milan-Bicocca Milan Italy.
Paul RichardsonRoyal Liverpool University National Health Service Trust Liverpool United Kingdom.
Sulleman MoreeaDepartment of Gastroenterology Bradford Teaching Hospitals National Health Service Foundation Trust Bradford United Kingdom.
C Anne McCuneDepartment of Hepatology Bristol Royal Infirmary Bristol United Kingdom.
Stephen D RyderNIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals National Health Service Trust and The University of Nottingham Nottingham United Kingdom.
Roger W ChapmanTranslational Gastroenterology Unit John Radcliffe Hospital Oxford United Kingdom.
Annarosa FloreaniDepartment of Surgery, Oncology and Gastroenterology University of Padua Padua Italy.
David E JonesNIHR Newcastle Biomedical Research Centre and the Institute of Cellular Medicine Newcastle University Newcastle upon Tyne United Kingdom.
Cristina de MinNovimmune SA Plan-les-Ouates Switzerland.
David H AdamsCentre for Liver Research University of Birmingham Birmingham United Kingdom.ORCID 0000-0001-6776-0336
Pietro InvernizziDivision of Gastroenterology and Program for Autoimmune Liver Diseases, International Center for Digestive Health, Department of Medicine and Surgery University of Milan-Bicocca Milan Italy.
Light Chain Bioscience (Switzerland) · CHNational Health Service · GBNational Institute for Health Research · GBUniversity of Milan · ITBristol Royal Infirmary · GBJohn Radcliffe Hospital · GBNIHR Newcastle Biomedical Research Centre · GBUniversity of Padua · IT

Funding

Medical Research Council G0300101Medical Research Council G0300102Medical Research Council G0400496Medical Research Council G0700301Medical Research Council G0802577
6 · The paper itself

Abstract

NI-0801 is a fully human monoclonal antibody against chemokine (C-X-C motif) ligand 10 (CXCL10), which is involved in the recruitment of inflammatory T cells into the liver. The safety and efficacy of NI-0801 was assessed in patients with primary biliary cholangitis. In this open-label phase 2a study, patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid received six consecutive intravenous administrations of NI-0801 (10 mg/kg) every 2 weeks. Patients were followed up for 3 months after the last infusion. Liver function tests, safety assessments, as well as pharmacokinetic and pharmacodynamic parameters were evaluated at different time points throughout the dosing period and the safety follow-up period. Twenty-nine patients were enrolled in the study and were treated with NI-0801. The most frequently reported adverse events included headaches (52%), pruritus (34%), fatigue (24%), and diarrhea (21%). No study drug-related serious adverse events were reported. NI-0801 administration did not lead to a significant reduction in any of the liver function tests assessed at the end of the treatment period (i.e., 2 weeks after final NI-0801 administration) compared to baseline.

Identifiers

PMID29761166
PMCPMC5944576
OpenAlexW2790210268

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.