Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects

Abstract

The effect of abatacept, a selective T-cell co-stimulation modulator, on vaccination has not been previously investigated. In this open-label, single-dose, randomized, parallel-group, controlled study, the effect of a single 750 mg infusion of abatacept on the antibody response to the intramuscular tetanus toxoid vaccine (primarily a memory response to a T-celldependent peptide antigen) and the intramuscular 23-valent pneumococcal vaccine (a less T-cell-dependent response to a polysaccharide antigen) was measured in 80 normal healthy volunteers. Subjects were uniformly randomized to receive one of four treatments: Group A (control group), subjects received vaccines on day 1 only; Group B, subjects received vaccines 2 weeks before abatacept; Group C, subjects received vaccines 2 weeks after abatacept; and Group D, subjects received vaccines 8 weeks after abatacept. Anti-tetanus and antipneumococcal (Danish serotypes 2, 6B, 8, 9V, 14, 19F and 23F) antibody titers were measured 14 and 28 days after vaccination. While there were no statistically significant differences between the dosing groups, geometric mean titers following tetanus or pneumococcal vaccination were generally lower in subjects who were vaccinated 2 weeks after receiving abatacept, compared with control subjects. A positive response (defined as a twofold increase in antibody titer from baseline) to tetanus vaccination at 28 days was seen, however, in ≥ 60% of subjects across all treatment groups versus 75% of control subjects. Similarly, over 70% of abatacept-treated subjects versus all control subjects (100%) responded to at least three pneumococcal serotypes, and approximately 25-30% of abatacept-treated subjects versus 45% of control subjects responded to at least six serotypes.

Influenza and Meningococcal Vaccinations Are Effective in Healthy Subjects Treated with the Interleukin-1β-Blocking Antibody Canakinumab: Results of an Open-Label, Parallel Group, Randomized, Single-Center Study

“…Previous reports have shown that patients with RA and psoriatic arthritis treated with adalimumab and etanercept were still able to develop an effective response to the tested influenza and pneumococcal vaccines (13,18), while other agents, like rituximab, did affect vaccine effectiveness (21). The percentage of healthy subjects responding to influenza vaccination observed in the present study was higher than the percentage of subjects re- sponding to pneumococcal vaccination (11) or to tetanus toxoid with Abatacept 750 (24).…”

Vaccination recommendations for adult patients rheumatic diseases

“…Abatasept kesildikten 2 hafta sonra bile immün yan›t›n düflük oldu¤u görül-müfltür. [18] Rituksimab kesildikten sonra ise en az 6 ay beklenmesi önerilir. [19] Ancak influenza afl›s› gibi belirli bir zaman aral›¤›nda yap›lmas› gereken bir afl› ise, düflük etkinlik göze al›narak afl› yap›lmal›d›r.…”

Vaccine Responses in Patients with Rheumatoid Arthritis Treated with Certolizumab Pegol: Results from a Single-blind Randomized Phase IV Trial

“…While protective titers have been shown in both TNF inhibitor and control groups, responses to vaccination (≥ 2-fold increases in titer from baseline) have been lower, or no different from controls, in those receiving TNF inhibitors 18,19,21 . Variable vaccine response has also been reported for other biologic agents that inhibit T cell co-stimulation or deplete B cells 22,23,24 ; vaccine response can also be affected by other co-factors such as age, sex, and genomics 25 .…”