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

作者:Alten Rieke*; Bingham Clifton O III; Cohen Stanley B; Curtis Jeffrey R; Kelly Sheila; Wong Dennis; Genovese Mark C
来源:BMC Musculoskeletal Disorders, 2016, 17(1): 231.
DOI:10.1186/s12891-016-1082-z

摘要

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 mu g/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 mu g/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.

  • 出版日期2016-5-26