Background
Methods
Study design
Assessments
Statistical analyses
Results
Patient population
Characteristic | Pneumococcal vaccine population (N = 125) |
---|---|
Age | |
Mean (SD), years | 45.7 (13.8) |
Sex | |
Women, n (%) | 107 (85.6) |
Men, n (%) | 18 (14.4) |
Race | |
White, n (%) | 124 (99.2) |
Black/African American, n (%) | 1 (0.8) |
Region | |
South America, n (%) | 105 (84.0) |
North America, n (%) | 20 (16.0) |
Weight | |
Mean (SD), kg | 68.9 (17.9) |
Duration of abatacept exposure during main study | |
Mean (SD), months | 26.4 (2.5) |
Tender joint count/28 | |
Mean (SD) | 20.4 (16.7) |
Swollen joint count/28 | |
Mean (SD) | 13.9 (11.5) |
Patient pain | |
100-mm VAS, mean (SD) | 51.0 (29.4) |
HAQ-DI | |
Mean (SD) | 1.4 (0.8) |
C-reactive protein | |
Mean (SD), mg/dL | 1.8 (2.5) |
Patient global assessment | |
100-mm VAS, mean (SD) | 43.9 (31.9) |
Physician global assessment | |
100-mm VAS, mean (SD) | 48.5 (26.3) |
DAS28 (C-reactive protein) | |
Mean (SD) | 5.0 (1.9) |
Concomitant methotrexate | |
n (%) | 115 (92.0) |
Characteristic | Influenza vaccine population (N = 191) |
---|---|
Age | |
Mean (SD), years | 44.9 (12.6) |
Sex | |
Women, n (%) | 172 (90.1) |
Men, n (%) | 19 (9.9) |
Race | |
White, n (%) | 188 (98.4) |
Black/African American, n (%) | 2 (1.0) |
Other, n (%) | 1 (0.5) |
Region | |
South America, n (%) | 156 (81.7) |
North America, n (%) | 35 (18.3) |
Weight | |
Mean (SD), kg | 68.4 (17.3) |
Duration of abatacept exposure during main study | |
Mean (SD), months | 37.6 (2.9) |
Tender joint count/28 | |
Mean (SD) | 30.7 (14.4) |
Swollen joint count/28 | |
Mean (SD) | 20.3 (8.0) |
Patient pain | |
100-mm VAS, mean (SD) | 65.5 (22.2) |
HAQ-DI | |
Mean (SD) | 1.7 (0.6) |
C-reactive protein, | |
Mean (SD), mg/dL | 2.4 (2.7) |
Patient global assessment | |
100-mm VAS, mean (SD) | 64.7 (21.5) |
Physician global assessment, 100-mm VAS | |
100-mm VAS, mean (SD) | 60.3 (17.9) |
DAS28 (C-reactive protein) | |
Mean (SD) | 6.3 (0.8) |
Concomitant methotrexate | |
n (%) | 186 (97.4) |
Efficacy
Immunologic responses to vaccination
Pneumococcal vaccine (n = 113) | Influenza vaccine (n = 186) | |
---|---|---|
Primary definition | ||
Patients without protective antibody levels at baselinea
| ||
n/N (%) | 34/46 (73.9) | 73/119 (61.3) |
95 % CI | 61.2, 86.6 | 52.6, 70.1 |
Patients with protective antibody levels at baseline | ||
n/N (%) | 28/66 (42.4) | 18/65 (27.7) |
95 % CI | 30.5, 54.3 | 16.8, 38.6 |
Total | ||
n/N (%) | 62/112 (55.4) | 91/184 (49.5) |
95 % CI | 46.2, 64.6 | 42.2, 56.7 |
Conservative definition | ||
Patients without protective antibody levels at baselinea
| ||
n/N (%) | 16/46 (34.8) | N/A |
95 % CI | 21.0, 48.5 | |
Patients with protective antibody levels at baseline | ||
n/N (%) | 8/65 (12.3) | N/A |
95 % CI | 4.3, 20.3 | |
Total | ||
n/N (%) | 24/111 (21.6) | N/A |
95 % CI | 14.0, 29.3 |
Baseline characteristic | Pneumococcal vaccine | Influenza vaccine | |||
---|---|---|---|---|---|
n/N (%) | OR (95 % CI) | n/N (%) | OR (95 % CI) | ||
Patients without protective antibody levels at baselinea
| |||||
MTX dose at baseline, mg/week | None | 2/4 (50.0) | 0.3 (0.0, 3.0) | 1/3 (33.3) | 0.4 (0.0, 4.5) |
>0–10 | 5/7 (71.4) | 0.6 (0.1, 6.0) | 17/25 (68.0) | 1.6 (0.5, 4.7) | |
>10–15 | 19/25 (76.0) | 0.8 (0.1, 4.8) | 35/36 (62.5) | 1.3 (0.5, 3.0) | |
>15 | 8/10 (80.0) | 20/35 (57.1) | |||
Steroid at baseline | Yes | 19/26 (73.1) | 0.9 (0.2, 3.4) | 47/74 (63.5) | 1.3 (0.6, 2.7) |
No | 15/20 (75.0) | 26/45 (57.8) | |||
Age at main study baseline, years | <55 | 28/35 (80.0) | 3.3 (0.8, 14.2) | 60/88 (68.2) | 3.0 (1.3, 6.9) |
≥55 | 6/11 (54.5) | 13/31 (41.9) | |||
Patients with protective antibody levels at baselinea
| |||||
MTX dose at baseline, mg/week | None | 2/6 (33.3) | 0.6 (0.1, 4.1) | 3/5 (60.0) | 3.6 (0.5, 26.8) |
>0–10 | 8/15 (53.3) | 1.4 (0.4, 5.4) | 3/12 (25.0) | 0.8 (0.2, 3.9) | |
>10–15 | 9/25 (36.0) | 0.7 (0.2, 2.3) | 5/24 (20.8) | 0.6 (0.2, 2.4) | |
>15 | 9/20 (45.0) | 7/24 (29.2) | |||
Steroid at baseline | Yes | 16/37 (43.2) | 1.1 (0.4, 2.9) | 10/40 (25.0) | 0.7 (0.2, 2.1) |
No | 12/29 (41.4) | 8/25 (32.0) | |||
Age at main study baseline, years | <55 | 23/47 (48.9) | 2.7 (0.8, 8.6) | 16/52 (30.8) | 2.4 (0.5, 12.3) |
≥55 | 5/19 (26.3) | 2/13 (15.4) | |||
Total populationb
| |||||
Protective antibody level at baseline | Yes | 28/66 (42.4) * | 0.3 (0.1, 0.6) | 18/65 (27.7) ** | 0.2 (0.1, 0.5) |
No | 34/46 (73.9) * | 73/119 (61.3) ** | |||
MTX dose at baseline, mg/week | None | 4/10 (40.0) | 0.5 (0.1, 2.2) | 4/8 (50.0) | 1.2 (0.3, 5.2) |
>0–10 | 13/22 (59.1) | 1.1 (0.4, 3.4) | 20/37 (54.1) | 1.4 (0.6, 3.2) | |
>10–15 | 28/50 (56.0) | 1.0 (0.4, 2.4) | 40/80 (50.0) | 1.2 (0.6, 2.3) | |
>15 | 17/30 (56.7) | 27/59 (45.8) | |||
Steroid at baseline | Yes | 35/63 (55.6) | 1.0 (0.5, 2.2) | 57/114 (50.0) | 1.1 (0.6, 1.9) |
No | 27/49 (55.1) | 34/70 (48.6) | |||
Age at main study baseline, years | <55 | 51/82 (62.2) | 2.8 (1.2, 6.8) *** | 76/140 (54.3) | 2.3 (1.1, 4.7) *** |
≥55 | 11/30 (36.7) | 15/44 (34.1) |