Evidence map›Paper›PMID 22673636›Full record

Trial reportJournal of Crohn's & colitis2013

Immune response to influenza A/H1N1 vaccine in inflammatory bowel disease patients treated with anti TNF-α agents: effects of combined therapy with immunosuppressants.

G Andrisani, D Frasca, M Romero, A Armuzzi, C Felice, M Marzo, D Pugliese, A Papa, G Mocci, I De Vitis and 3 more

Open access · greenAbstract readClinical TrialComparative Study
In one paragraph

Trial report in Journal of Crohn's & colitis, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 5 pooled it
3.7field-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

45 citing papers in PubMed, 5 syntheses or guidelines pooled it, 91 citations in OpenAlex.

  1. Turkish IBD Organization's Position Statement on Inflammatory Bowel Disease Management Recommendations During COVID-19 Pandemic.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2021
    Guideline
  2. Pooled it
  3. ACG Clinical Guideline: Preventive Care in Inflammatory Bowel Disease.The American journal of gastroenterology · 2017
    Guideline
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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

13 authors at 2 institutions in 2 countries.

G AndrisaniOperative Unit of Internal Medicine and Gastroenterology, Complesso integrato Columbus, Catholic University Sacro Cuore, Roma, Italy.
D Frasca
M Romero
A Armuzzi
C Felice
M Marzo
D Pugliese
A Papa
G Mocci
I De Vitis
G L Rapaccini
B B Blomberg
L Guidi
Università Cattolica del Sacro Cuore · ITUniversity of Miami · US

Funding

Regulation of B Lymphocyte Defects in Senescent HumansR01AG032576 · NIA · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI BLOMBERG, BONNIE B. · 2009 to 2014
$1.6M
Molecular mechanisms for TNF-mediated inhibition of B lymphocyte functionR21AI096446 · NIAID · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI BLOMBERG, BONNIE B., FRASCA, DANIELA · 2012 to 2013
$407k
NIAID NIH HHS R21 AI096446NIA NIH HHS R01 AG032576
6 · The paper itself

Abstract

BACKGROUND AND

aimsOur first objective was to evaluate the immune response to the adjuvanted 2009 A/H1N1 pandemic (pH1N1) vaccine in inflammatory bowel disease (IBD) patients treated with anti-TNF-α alone or combined with immunosuppressants (IS). Second and third aims were the safety of pH1N1 vaccine and the effects on IBD clinical activity.

methods36 patients with Crohn's disease (CD) and 26 with ulcerative colitis (UC) and thirty-one healthy control (HC) subjects were enrolled. 47 patients were on anti TNF-α maintenance monotherapy and 15 on anti TNF-α combined with IS. Sera were collected at baseline (T0) and 4 weeks after the vaccination (T1) for antibody determination by hemagglutination inhibition (HAI). Disease activity was monitored at T0 and T1.

resultsSeroprotective titers (≥1:40) in patients were comparable to HC. Seroconvertion rate (≥4 fold increase in HAI titer) was lower than HC in IBD patients (p=0.009), either on anti TNF-α monotherapy (p=0.034) or combined with IS (p=0.011). Geometric mean titer (GMT) of antibodies at T1 was significantly lower in patients on combined therapy versus those on monotherapy (p=0.0017) and versus HC (p=0.011). The factor increase of GMT at T1 versus T0 was significantly lower in IBD patients versus HC (p=0.042), and in those on combined immunosuppression, both versus monotherapy (p=0.0048) and HC (p=0.0015). None of the patients experienced a disease flare.

conclusionOur study has shown a suboptimal response to pH1N1 vaccine in IBD patients on therapy with anti TNF-α and IS compared to those on anti-TNF-α monotherapy and HC.

Indexed as

AdalimumabAdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, ViralAnti-Inflammatory Agents, Non-SteroidalBiomarkersCase-Control StudiesCertolizumab PegolColitis, UlcerativeCrohn DiseaseDisease ProgressionDrug Therapy, CombinationFemaleAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntibodies, ViralAnti-Inflammatory Agents, Non-SteroidalBiomarkersCertolizumab PegolImmunoglobulin Fab FragmentsImmunosuppressive AgentsInfliximabInfluenza VaccinesPolyethylene Glycols

Identifiers

PMID22673636
PMCPMC3862353
OpenAlexW2052160307

What OpenQuestion holds

Textmetadata
LicenceTDM
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.