ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 454

Antibody Response To Pneumococcal and Influenza Vaccination In Patients With Rheumatoid Arthritis Receiving Subcutaneous Abatacept

MC Genovese1, Clifton O. Bingham III2, S Cohen3, Leonard H. Calabrese4, JR Curtis5, A Block6, J Fay6, S Kelly7, A Luo6, D Wong6 and R Alten8, 1Stanford University, Palo Alto, CA, 2Johns Hopkins University, Baltimore, MD, 3Metroplex Clinical Research Center, Dallas, TX, 4Cleveland Clinic Foundation, Cleveland, OH, 5University of Alabama at Birmingham, Birmingham, AL, 6Bristol-Myers Squibb, Princeton, NJ, 7Bristol-Myers Squibb, Plainsboro, NJ, 8Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Rheumatoid Arthritis Treatment - Small Molecules, Biologics and Gene Therapy I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Previous small studies have suggested that responses to some immunizations may be attenuated by intravenous abatacept but remain clinically meaningful.1,2 We investigated the magnitude of antibody response to the standard 23-valent pneumococcal polysaccharide vaccine (PPV23) and the 2011–2012 seasonal influenza trivalent vaccine in a large number of adult patients (pts) with RA receiving subcutaneous (SC) abatacept and background DMARDs. Methods: Two multicenter, open-label sub-studies of PPV23 and seasonal influenza vaccine enrolled pts in the ACQUIRE (pneumococcal and influenza) or ATTUNE (pneumococcal) studies. Pts were enrolled at any point during their SC abatacept treatment cycle after completion of ≥3 months’ abatacept treatment. All pts received fixed-dose SC abatacept 125 mg/week with background DMARDs. A pre-vaccination blood sample was collected and vaccines administered, while continuing background SC abatacept and DMARDs. After 28 ± 3 days, a final post-vaccination blood sample was collected. For PPV23, the primary endpoint was the proportion of pts achieving an immunologic response, defined as a ≥2-fold increase in post-vaccination titers to ≥3 of 5 evaluated pneumococcal antigens (9V, 14, 18C, 19F, and 23F) in the vaccine at Day 28 in the subgroup of pts without a protective antibody level (titer ≥1.6 μg/mL to ≥3 of 5 pneumococcal antigens) to these antigens at baseline. For influenza vaccination, the primary endpoint was the proportion of the subgroup of pts achieving an immunologic response, defined as a ≥4-fold increase in post-vaccination titers to ≥2 of 3 evaluated 2011–2012 influenza antigens (H1N1, H3N2, and Brisbane) at Day 28 in pts without a protective antibody level (titer ≥1:40 to ≥2 of 3 influenza antigens) to these antigens at baseline. Safety and tolerability were assessed throughout the studies.   Results: Pre- and post-vaccination titers were available for 113/125 and 186/191 enrolled pts receiving the pneumococcal and influenza vaccines, respectively. Among vaccinated pts, 47/113 pneumococcal and 121/186 influenza pts were without protective antibody levels at baseline. Of these pts, 73.9% (34/46) and 61.3% (73/119) met the primary endpoint and demonstrated an immunologic response to PPV23 or influenza vaccine, respectively. In all pts who received the vaccine and had pre- and post-vaccination antibody titers available at 4 weeks post-vaccination, 83.9% (94/112) demonstrated protective antibody levels with PPV23 (titer ≥1.6 μg/mL to ≥3 of 5 pneumococcal antigens), and 82.1% (151/184) in the influenza study demonstrated protective antibody levels (titer ≥1:40 to ≥2 of 3 influenza antigens). Vaccination during SC abatacept administration was well tolerated, with no new safety signals identified.

Conclusion: In this group of pts with RA on SC abatacept and background DMARDs, most pts without protective antibody levels at baseline were able to mount an immune response to the PPV23 and influenza virus vaccines, and vaccination was well tolerated. These data are consistent with previous smaller studies.

  1. Tay L, et al. Arthritis Res Ther 2007;9:R38 2. Schiff M, et al. Arthritis Rheum 2007;56:S392  

Disclosure:

M. Genovese,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

5;

C. O. Bingham III,

Bristol-Myers Squibb,

5,

Bristol-Myers Squibb,

2;

S. Cohen,

Amgen, Biogen Idec, Bristol-Myers Squibb, Centocor, Genentech, Johnson Johnson, Pfizer, Merck, Roche,

2;

L. H. Calabrese,
None;

J. Curtis,

Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie,

2,

Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie,

5;

A. Block,

Bristol-Myers Squibb,

3,

Bristol-Myers Squibb,

1;

J. Fay,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

S. Kelly,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

A. Luo,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

D. Wong,

Bristol-Myers Squibb,

1,

Bristol-Myers Squibb,

3;

R. Alten,

Bristol-Myers Squibb,

2,

Bristol-Myers Squibb,

9.

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