Evidence map›Paper›PMID 27229685›Full record

Trial reportBMC musculoskeletal disorders2016

Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept.

Rieke Alten, Clifton O Bingham, Stanley B Cohen, Jeffrey R Curtis, Sheila Kelly, Dennis Wong, Mark C Genovese

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC musculoskeletal disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 6 pooled it
5.7field-weighted citation impact, top 4% 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.

NCT00559585 phase3completednot on this map

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

TypeinterventionalSponsorBristol-Myers SquibbRan2008 to 2014Enrolled2,492ConditionsRheumatoid Arthritis (RA)ArmsSubcutaneous (SC) Abatacept, Intravenous (IV) Abatacept
NCT00663702 phase3completednot on this map

A Phase 3B Multi-center Open-Label Study to Evaluate the Safety of Abatacept in Subjects Who Switch From Intravenous to Subcutaneous Abatacept Therapy

TypeinterventionalSponsorBristol-Myers SquibbRan2008 to 2012Enrolled123ConditionsArthritis, RheumatoidArmsAbatacept
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 6 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Guideline
  4. Guideline
  5. Guideline
  6. Pooled it
  7. Vaccination Update and Specific Concerns for RA.Current rheumatology reports · 2025
    Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. COVID-19 vaccination and antirheumatic therapy.Rheumatology (Oxford, England) · 2021
    Review
  19. Review
  20. Article
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

7 authors at 6 institutions in 2 countries.

Rieke AltenSchlosspark-Klinik University Medicine, Berlin, Germany. rieke.alten@schlosspark-klinik.de.
Clifton O BinghamJohns Hopkins University, Baltimore, MD, USA.
Stanley B CohenMetroplex Clinical Research Center, Dallas, TX, USA.
Jeffrey R CurtisUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Sheila KellyBristol-Myers Squibb, Princeton, NJ, USA.
Dennis WongBristol-Myers Squibb, Princeton, NJ, USA.
Mark C GenoveseStanford University, Palo Alto, CA, USA.
Bristol-Myers Squibb (United States) · USJohns Hopkins University · USMetroplex Clinical Research Center · USPalo Alto University · USSchlosspark-Klinik · DEUniversity of Alabama at Birmingham · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with rheumatoid arthritis (RA), including those treated with biologics, are at increased risk of some vaccine-preventable infections. We evaluated the antibody response to standard 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the 2011-2012 trivalent seasonal influenza vaccine in adults with RA receiving subcutaneous (SC) abatacept and background disease-modifying anti-rheumatic drugs (DMARDs).

methodsTwo multicenter, open-label sub-studies enrolled patients from the ACQUIRE (pneumococcal and influenza) and ATTUNE (pneumococcal) studies at any point during their SC abatacept treatment cycle following completion of ≥3 months' SC abatacept. All patients received fixed-dose abatacept 125 mg/week with background DMARDs. A pre-vaccination blood sample was taken, and after 28 ± 3 days a final post-vaccination sample was collected. The primary endpoint was the proportion of patients achieving an immunologic response to the vaccine at Day 28 among patients without a protective antibody level to the vaccine antigens at baseline (pneumococcal: defined as ≥2-fold increase in post-vaccination titers to ≥3 of 5 antigens and protective antibody level of ≥1.6 μg/mL to ≥3 of 5 antigens; influenza: defined as ≥4-fold increase in post-vaccination titers to ≥2 of 3 antigens and protective antibody level of ≥1:40 to ≥2 of 3 antigens). Safety and tolerability were evaluated throughout the sub-studies.

resultsPre- and post-vaccination titers were available for 113/125 and 186/191 enrolled patients receiving the PPSV23 and influenza vaccine, respectively. Among vaccinated patients, 47/113 pneumococcal and 121/186 influenza patients were without protective antibody levels at baseline. Among patients with available data, 73.9 % (34/46) and 61.3 % (73/119) met the primary endpoint and achieved an immunologic response to PPSV23 or influenza vaccine, respectively. In patients with pre- and post-vaccination data available, 83.9 % in the pneumococcal study demonstrated protective antibody levels with PPSV23 (titer ≥1.6 μg/mL to ≥3 of 5 antigens), and 81.2 % in the influenza study achieved protective antibody levels (titer ≥1:40 to ≥2 of 3 antigens) at Day 28 post-vaccination. Vaccines were well tolerated with SC abatacept with background DMARDs.

conclusionsIn these sub-studies, patients with RA receiving SC abatacept and background DMARDs were able to mount an appropriate immune response to pneumococcal and influenza vaccines.

trial registrationNCT00559585 (registered 15 November 2007) and NCT00663702 (registered 18 April 2008).

Indexed as

AbataceptAdultAntibodies, BacterialAntibodies, ViralAntirheumatic AgentsArthritis, RheumatoidFemaleHumansImmunosuppressive AgentsInfluenza, HumanInfluenza VaccinesInjections, SubcutaneousMaleMiddle AgedPneumococcal InfectionsPneumococcal Vaccines23-valent pneumococcal capsular polysaccharide vaccineAbataceptAntibodies, BacterialAntibodies, ViralAntirheumatic AgentsImmunosuppressive AgentsInfluenza VaccinesPneumococcal VaccinesAbataceptImmunizationInfluenzaPneumococcalRheumatoid arthritisVaccination

Identifiers

PMID27229685
PMCPMC4880815
OpenAlexW2397253867

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.