Table 2 Immune response following vaccination with single dose, two doses or irrespective of number of doses
|  | All patients (number = 291) | RA on MTX (number = 50) | RA on anti-TNF monotherapy (number = 38) | RA on anti-TNF + MTX (number = 53) | RA on abatacept (number = 5) | RA on rituximab (number = 10) | RA on tocilizumab (number = 2) | SpA on anti-TNF monotherapy (number = 41) | SpA on anti-TNF + MTX (number = 51) | SpA on NSAIDs/ analgesics controls (number = 41) |
|---|---|---|---|---|---|---|---|---|---|---|
Patients immunized with a single dose of the vaccine (number = 123) | ||||||||||
Number of patients | 123 | 18 | 18 | 15 | 3 | 4 | 0 | 13 | 18 | 34 |
GMT prevaccination mean (95% CI) | 9.3 (7.2 to 12.1) | 6.8 (5.1 to 9.1) | 10.8 (6.4 to 18.3) | 6.9 (5 to 9.5) | 16 (1.1 to 220) | 7.1 (2.3 to 21.3) | --- | 8.5 (5.4 to 13.5) | 10 (6.9 to 14.5) | 8.8 (6.7 to 11.7) |
GMT postvaccination mean (95% CI) | 52.4 (34.3 to 80.1) | 34.3 (16.6 to 70.8) | 30.5 (14.6 to 64) | 19.1 (11.2 to 32.5) | 49 (2 to 790) | 14.1 (3.4 to 59) | --- | 40 (21.6 to 74) | 23.3 (12.7 to 43) | 46.1 (29 to 73.9) |
Geometric mean fold increase (95% CI) | 5.6 (3.6 to 8.8) | 5 (2.1 to 12.2) | 2.8 (1.6 to 5.1) | 2.8 (1.4 to 5.4) | 2.5 (0.3 to 18.4) | 2 (0.4 to 9.5) | --- | 4.7 (2.1 to 10.5) | 2.3 (1.1 to 4.8) | 5.2 (3.2 to 8.4) |
Number (% ) of patients with prevaccination titer ≥40 | 8 (7%) | 0 | 2 (11%) | 0 | 1 (33%) | 0 | --- | 1 (8%) | 1 (6%) | 3 (9%) |
Number (% ) of patients with postvaccination titer ≥40 (seroprotection) | 61 (49.1%) | 9 (50%) | 8 (44%) | 6 (40%) | 1 (33%) | 1 (25%) | --- | 7 (54%) | 8 (44%) | 21 (62%) |
Number (%) of patients with positive immune response (seroconversion)a | 55 (45%) | 8 (44%) | 6 (33%) | 6 (40%) | 1 (33%) | 1 (25%) | ---- | 7 (54%) | 7 (39%) | 19 (56%) |
% immunized with seasonal influenza vaccine (2009/2010) | 22 | 33 | 44 | 20 | 0 | 0 | ---- | 0 | 11 | 24 |
aNo significant differences between treatment groups. | ||||||||||
Patients immunized with two doses of the vaccine (number = 168) | ||||||||||
Number of patients | 168 | 32 | 20 | 38 | 2 | 6 | 2 | 28 | 33 | 7 |
GMT prevaccination mean (95% CI) | 9.2 (8.2 to 10.4) | 9.8 (7.1 to 13.4) | 8.7 (6.3 to 12.1) | 6.8 (5.6 to 8.3) | 20 (3.3 to 121) | 7.9 (3.7 to 16.8) | 28 (0.3 to 2312) | 9.5 (7.1 to 12.7) | 10.7 (8.1 to 14.1) | 12.2 (5 to 29.5) |
GMT postvaccination mean (95% CI) | 50 (40.4 to 61.8) | 40 (23.9 to 67.5) | 72 (33 to 159) | 34 (21.5 to 54) | 33.6 (6.4 to 176) | 8.9 (3.8 to 21) | 113 | 102.5 (69 to 153) | 48.3 (32 to 73.4) | 97.5 (33 to 291) |
Geometric mean fold increase (95% CI) | 5.4 (4.3 to 6.8) | 4.1 (2.5 to 6.7) | 8.3 (3.7 to 18.5) | 5 (3–8.3) | 2 | 1.1 (0.5 to 2.6) | 4 (0---) | 11 (6.7 to 17.3) | 4.5 (2.6 to 7.8) | 8 (1.5 tp\o 43.6) |
N (% ) of patients with prevaccination titer ≥40 | 17 (10%) | 6 (19%) | 1 (5%) | 1 (3%) | 1 (50%) | 0 | 1 (50%) | 2 (7%) | 3 (9%) | 2 (29%) |
N (% ) of patients with postvaccination titer ≥40 | 106 (63%) | 16 (50%) | 14 (70%) | 18 (48%) | 1 (50%) | 1 (17%) | 2 (100%) | 24 (86%) | 24 (73%) | 6 (86%) |
N (%) of patients with positive immune response (seroconversion) | 91 (54%) | 13 (41%)b | 14 (70%) | 17 (45%) | 0 | 0 | 1 (50%) | 24 (86%)a | 17 (52%) | 5 (71%) |
% immunized with seasonal influenza vaccine (2009/2010) | 46% | 59% | 40% | 51% | 100 | 50 | 100 | 32 | 36 | 43 |
aP = 0.003 compared to RA on MTX; P = 0.033 compared to RA on anti-TNF monotherapy; P = 0.001 compared to RA on anti-TNF + MTX; P = 0.005 compared to SpA on antiTNF + MTX; bP = 0.039 versus RA on anti-TNF monotherapy (Chi2 test). | ||||||||||
All vaccinated patients regardless of number of doses (number = 291) | ||||||||||
Number of patients | 291 | 50 | 38 | 53 | 5 | 10 | 2 | 41 | 51 | 41 |
GMT prevaccination mean (95% CI) | 9 (8.2 to 9.8) | 8.6 (6.8 to 10.8) | 9.6 (7.2 to 12.9) | 6.8 (5.8 to 8) | 17.4 (3.7 to 81.2) | 7.6 (4.7 to 12.2) | 28.3 ----- | 9.2 (7.3 to 11.6) | 10.4 (8.4 to 12.9) | 9.3 (7.2 to 12.1) |
GMT postvaccination mean (95% CI) | 41.4 (35.3 to 48.4) | 37.8 (25.1 to 57) | 48 (28.1 to 82.1) | 28.8 (20.2 to 41.3) | 40 (11.8 to 135) | 10.7 (5.9 to 19.4) | 113.1 ----- | 76 (53.5 to 105) | 37.4 (26.4 to 53) | 52.4 (34.3 to 80.1) |
Geometric mean fold increase (95% CI) | 4.6 (3.9 to 5-5) | 4.4 (2.9 to 6.9) | 5 (3 to 8.3) | 4.2 (2.8 to 6.3) | 2.3 (0.9 to 5.9) | 1.4 (0.8 to 2.6) | 4 | 8.3 (5.5 to 12.5) | 3.6 (2.3 to 5.5) | 5.6 (3.6 to 8.8) |
N (% ) of patients with prevaccination titer ≥40 | 25 (9%) | 6 (12%) | 3 (8%) | 1 (2%) | 2 (40%) | 0 | 1 (50%) | 3 (7%) | 4 (8%) | 5 (12%) |
N (% ) of patients with postvaccination titer ≥40 (seroprotection) | 167 (57%) | 25 (50%) | 22 (58%) | 24 (45%) | 2 (40%) | 2 (20%) | 2 (100%) | 31 (76%) | 33 (63%) | 27 (66%) |
N (%) of patients with positive immune response (seroconversion) | 146 (50%) | 21 (42%)b | 20 (53%)c | 23 (43%)d | 1 (20%) | 1 (10%) | 1 (50%) | 31 (76%)a | 24 (47%) | 24 (59%) |
% immunized with seasonal influenza vaccine (2009/2010) | 104 (36%) | 50% | 42% | 42% | 40% | 30% | 100% | 22% | 28% | 27% |
aP = 0.001 compared to RA on MTX; P = 0.033 compared to RA on anti-TNF as monotherapy; P = 0.002 compared to RA on anti-TNF + MTX; P = 0.011 compared to RA on abatacept; P < 0.001 compared to RA on rituximab; P = 0.006 compared to SpA on anti-TNF + MTX; bP = 0.05 compared to RA on rituximab; cP = 0.013 compared to RA on rituximab; P = 0.033 compared to SpA on dP = 0.046 compared to RA on rituximab (Chi2 test/Fisher’s exact test). | ||||||||||