Cited by 75Rheumatoid Arthritis Research and TherapiesPneumonia and Respiratory InfectionsImmunotoxicology and immune responses

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

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Alten, Rieke, Bingham, Clifton O., Cohen, Stanley B., Curtis, Jeffrey R., Kelly, Sheila, Wong, Dennis, Genovese, Mark C.·2016·BMC Musculoskeletal Disorders

Abstract

BACKGROUND: Patients 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). METHODS: Two 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. RESULTS: Pre- 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. CONCLUSIONS: In 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 REGISTRATION: NCT00559585 (registered 15 November 2007) and NCT00663702 (registered 18 April 2008).

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  1. Schiff M, Saewert M, Bahrt K, Genovese M. Response to influenza vaccine in rheumatoid arthritis patients with an inadequate response to anti-TNF therapy treated with abatacept in the ARRIVE Trial. Arthritis Rheum. 2007;56:S392.

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Authors
Alten, R., Bingham, C. O., Cohen, S. B., Curtis, J. R., Kelly, S., Wong, D., & Genovese, M. C.
Affiliations
  • Schlosspark-Klinik (DE)
  • Johns Hopkins University (US)
  • Metroplex Clinical Research Center (US)
  • University of Alabama at Birmingham (US)
  • Bristol-Myers Squibb (United States) (US)
  • Stanford University (US)
Corresponding author
Alten, Rieke
Venue
BMC Musculoskeletal Disorders
Published
2016-05-26
Volume
17
Issue
1
Pages
231-231
ISSN
1471-2474 (ISSN-L)
OpenAlex
W2397253867
Cited by
75
References
51
Citations by year
2026: 4 · 2025: 2 · 2024: 7 · 2023: 4 · 2022: 11 · 2021: 19 · 2020: 8 · 2019: 4 · 2018: 6 · 2017: 8 · 2016: 2
FWCI
7.09
Type
journal article
Language
en
Open access
Locations
  • BMC Musculoskeletal Disorders (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Refubium (Universitätsbibliothek der Freien Universität Berlin) (submittedVersion, cc-by)
Funders
Bristol-Myers Squibb
Topics
  • Health Sciences › Medicine › Rheumatology › Rheumatoid Arthritis Research and Therapies
  • Health Sciences › Medicine › Epidemiology › Pneumonia and Respiratory Infections
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotoxicology and immune responses
Keywords
rheumatoid arthritis, abatacept, pneumococcal polysaccharide vaccine, trivalent influenza vaccine, vaccine immunogenicity, antibody response, vaccine-preventable diseases, biologic therapy, disease-modifying antirheumatic drugs, vaccine safety and tolerability, protective antibody levels
MeSH terms
Abatacept, Adult, Antibodies, Bacterial, Antibodies, Viral, Arthritis, Rheumatoid, Female, Humans, Immunosuppressive Agents, Influenza, Human, Influenza Vaccines, Injections, Subcutaneous, Male, Middle Aged, Pneumococcal Infections, Vaccination, Antirheumatic Agents, Pneumococcal Vaccines

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