Evidence map›Paper›PMID 24448345›Full record

Trial reportAnnals of the rheumatic diseases2015

Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA).

Clifton O Bingham, Warren Rizzo, Alan Kivitz, Azra Hassanali, Ruchi Upmanyu, Micki Klearman

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IVRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01163747 (A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate), which is not on this map. Cited by 39 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 7 pooled it
7.1field-weighted citation impact, top 2% 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.

NCT01163747 phase4completednot on this map

A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

TypeinterventionalSponsorGenentech, Inc.Ran2010 to 2012Enrolled91ConditionsRheumatoid ArthritisArmstocilizumab, methotrexate, 23-Valent Pneumococcal Polysaccharide Vaccine, Tetanus Toxoid Adsorbed Vaccine
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 7 syntheses or guidelines pooled it, 105 citations in OpenAlex.

  1. Pooled it
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  8. Trial
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  12. Article
  13. Vaccination Update and Specific Concerns for RA.Current rheumatology reports · 2025
    Review
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  17. Observational
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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

6 authors at 4 institutions in 3 countries.

Clifton O BinghamDepartment of Medicine, Johns Hopkins University, Baltimore, Maryland, USA.
Warren RizzoAdvanced Arthritis Care, Scottsdale, Arizona, USA.
Alan KivitzAltoona Center for Clinical Research, Duncansville, Pennsylvania, USA.
Azra HassanaliGenentech, South San Francisco, California, USA.
Ruchi UpmanyuRoche, Welwyn Garden City, UK.
Micki KlearmanGenentech, South San Francisco, California, USA.
Altoona Center for Clinical Research · USArthritis Treatment Center · USJohns Hopkins University · USRoche (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effect of tocilizumab (TCZ), an interleukin 6 receptor inhibitor, on humoral immune responses to immunisations in patients with rheumatoid arthritis (RA).

methodsPatients with RA with inadequate response/intolerance to one or more anti-tumour necrosis factor-α agents were randomly assigned (2:1) to TCZ 8 mg/kg intravenously every 4 weeks plus methotrexate (MTX) or MTX alone up until week 8. Serum was collected before vaccination at week 3, antibody titres were evaluated at week 8, and then all patients received TCZ+MTX through week 20. End points included proportion of patients responding to ≥6/12 pneumococcal polysaccharide vaccine (PPV23) serotypes (primary) and proportions responding to tetanus toxoid vaccine (TTV; secondary) at week 8.

results91 patients were randomised. At week 8, 60.0% of TCZ+MTX and 70.8% of MTX patients responded to ≥6/12 PPV23 serotypes, with insufficient evidence for any difference in treatments (10.8% (95% CI -33.7 to 12.0)), and 42.0% and 39.1%, respectively, responded to TTV. Two of three TCZ+MTX patients with non-protective baseline TTV antibody titres achieved protective levels by week 8. The safety profile of TCZ was consistent with previous reports.

conclusionsShort-term TCZ treatment does not significantly attenuate humoral responses to PPV23 or TTV. To maximise vaccine response, patients should be up to date with immunisations before starting TCZ treatment. CLINICALTRIALSGOV IDENTIFIER: NCT01163747.

Indexed as

AdolescentAdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidFemaleHumansImmunity, HumoralMaleMethotrexateMiddle AgedPneumococcal InfectionsPneumococcal VaccinesTetanusTetanus ToxoidYoung AdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatePneumococcal VaccinesTetanus ToxoidtocilizumabMethotrexateRheumatoid ArthritisVaccination

Identifiers

PMID24448345
PMCPMC4392200
OpenAlexW2135025369

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.