Evidence map›Paper›PMID 34717923›Full record

Observational studyGastroenterology2022

Lower Serologic Response to COVID-19 mRNA Vaccine in Patients With Inflammatory Bowel Diseases Treated With Anti-TNFα.

Hadar Edelman-Klapper, Eran Zittan, Ariella Bar-Gil Shitrit, Keren Masha Rabinowitz, Idan Goren, Irit Avni-Biron, Jacob E Ollech, Lev Lichtenstein, Hagar Banai-Eran, Henit Yanai and 26 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 5 pooled it
–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

54 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Effectiveness and Durability of COVID-19 Vaccination in 9447 Patients With IBD: A Systematic Review and Meta-Analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022
    Pooled it
  4. Safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease: A systematic review and meta-analysis.Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2022
    Pooled it
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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

36 authors.

Hadar Edelman-KlapperDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Eran ZittanThe Abraham and Sonia Rochlin IBD Unit, Department of Gastroenterology, Emek Medical Center, Afula, Israel; Rappaport Faculty of Medicine Technion-Israel Institute of Technology, Haifa, Israel.
Ariella Bar-Gil ShitritDigestive Diseases Institute, Shaare Zedek Medical Center, Jerusalem, Israel; Faculty of Medicine, Hebrew University of Jerusalem, Israel.
Keren Masha RabinowitzDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Felsenstein Medical Research Center, Sackler School of Medicine, Tel Aviv, Israel.
Idan GorenDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Irit Avni-BironDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Jacob E OllechDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Lev LichtensteinClalit Health Services, Petah Tikva, Israel.
Hagar Banai-EranDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Henit YanaiDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Yifat SnirDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Maor H PaukerDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Adi FriedenbergDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
Adva Levy-BardaBiobank, Department of Pathology, Rabin Medical Center, Petah Tikva, Israel.
Arie SegalThe Institute of Gastroenterology and Hepatology, Soroka University Medical Center, Beer-Sheva, Israel.
Yelena BroitmanDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Eran MaozClalit Health Services, Tel Aviv, Israel.
Baruch OvadiaDepartment of Gastroenterology and Hepatology, Hillel Yaffe Medical Center, Hadera, Israel.
Maya Aharoni GolanDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Eyal ShacharSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Gastroenterology, Sheba Medical Center, Ramat Gan, Israel.
Shomron Ben-HorinSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Gastroenterology, Sheba Medical Center, Ramat Gan, Israel.
Tsachi-Tsadok PeretsGastroenterology Laboratory, Division of Gastroenterology, Rabin Medical Center, Israel; Adelson School of Medicine, Ariel University, Ariel, Israel.
Haim Ben ZviMicrobiology Lab, Rabin Medical Center, Petah Tikva, Israel.
Rami EliakimSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Gastroenterology, Sheba Medical Center, Ramat Gan, Israel.
Revital BarkanDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
Sophy GorenSchool of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Michal NavonDepartment of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Noy KrugliakDepartment of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Michal WerbnerMolecular Virology Lab, The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.
Joel AlterThe Laboratory of Structural Biology of Infectious Diseases, The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.
Moshe DessauThe Laboratory of Structural Biology of Infectious Diseases, The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.
Meital Gal-TanamyMolecular Virology Lab, The Azrieli Faculty of Medicine, Bar-Ilan University, Safed, Israel.
Natalia T FreundDepartment of Clinical Microbiology and Immunology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Dani CohenSchool of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Iris DotanDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: irisdo@clalit.org.il.
REsponses to COVid-19 vaccinE IsRaeli IBD group (RECOVER)

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimPatients with inflammatory bowel diseases (IBD), specifically those treated with anti-tumor necrosis factor (TNF)α biologics, are at high risk for vaccine-preventable infections. Their ability to mount adequate vaccine responses is unclear. The aim of the study was to assess serologic responses to messenger RNA-Coronavirus Disease 2019 vaccine, and safety profile, in patients with IBD stratified according to therapy, compared with healthy controls (HCs).

methodsProspective, controlled, multicenter Israeli study. Subjects enrolled received 2 BNT162b2 (Pfizer/BioNTech) doses. Anti-spike antibody levels and functional activity, anti-TNFα levels and adverse events (AEs) were detected longitudinally.

resultsOverall, 258 subjects: 185 IBD (67 treated with anti-TNFα, 118 non-anti-TNFα), and 73 HCs. After the first vaccine dose, all HCs were seropositive, whereas ∼7% of patients with IBD, regardless of treatment, remained seronegative. After the second dose, all subjects were seropositive, however anti-spike levels were significantly lower in anti-TNFα treated compared with non-anti-TNFα treated patients, and HCs (both P < .001). Neutralizing and inhibitory functions were both lower in anti-TNFα treated compared with non-anti-TNFα treated patients, and HCs (P < .03; P < .0001, respectively). Anti-TNFα drug levels and vaccine responses did not affect anti-spike levels. Infection rate (∼2%) and AEs were comparable in all groups. IBD activity was unaffected by BNT162b2.

conclusionsIn this prospective study in patients with IBD stratified according to treatment, all patients mounted serologic response to 2 doses of BNT162b2; however, its magnitude was significantly lower in patients treated with anti-TNFα, regardless of administration timing and drug levels. Vaccine was safe. As vaccine serologic response longevity in this group may be limited, vaccine booster dose should be considered.

Indexed as

AdultAntibodies, ViralBNT162 VaccineCase-Control StudiesCOVID-19FemaleHumansImmunogenicity, VaccineInflammatory Bowel DiseasesIsraelMaleMiddle AgedProspective StudiesSARS-CoV-2Tumor Necrosis Factor InhibitorsAntibodies, ViralBNT162 VaccineTumor Necrosis Factor InhibitorsCOVID-19mRNA-BNT162b2Serologic ResponseVaccine

Identifiers

PMID34717923
PMCPMC8552587

What OpenQuestion holds

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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.