Satisfactory humoral immune response to pneumococcal and influenza vaccines at Week 6a by stratification subgroups in patients without effective antibody titers at baselineb.
| Pneumococcal Response | Influenza Response | |||
|---|---|---|---|---|
| Treatment | PBO n/N (%) (95% CI) | CZP n/N (%) (95% CI) | PBO n/N (%) (95% CI) | CZP n/N (%) (95% CI) |
| Concomitant MTX use | ||||
| Yes | 30/60 (50.0) (37.3–62.7) | 28/63 (44.4) (32.2–56.7) | 29/57 (50.9) (37.9–63.9) | 27/59 (45.8) (33.1–58.5) |
| No | 25/28 (89.3) (77.8–100.0) | 20/25 (80.0) (64.3–95.7) | 22/26 (84.6) (70.7–98.5) | 19/27 (70.4) (53.1–87.6) |
| Any DMARD use (including MTX) | ||||
| Yes | 39/70 (55.7) (44.1–67.4) | 37/74 (50.0) (38.6–61.4) | 37/66 (56.1) (44.1–68.0) | 35/71 (49.3) (37.7–60.9) |
| No | 16/18 (88.9) (74.4–100.0) | 11/14 (78.6) (57.1–100.0) | 14/17 (82.4) (64.2–100.0) | 11/15 (73.3) (51.0–95.7) |
| Corticosteroid use | ||||
| Yes | 22/33 (66.7) (50.6–82.8) | 23/38 (60.5) (45.0–76.1) | 17/29 (58.6) (40.7–76.5) | 18/38 (47.4) (31.5–63.2) |
| No | 33/55 (60.0) (47.1–72.9) | 25/50 (50.0) (36.1–63.9) | 34/54 (63.0) (50.1–75.8) | 28/48 (58.3) (44.4–72.3) |
| CRP level | ||||
| ≤ 5 mg/lc | 24/44 (54.5) (39.8–69.3) | 24/40 (60.0) (44.8–75.2) | 26/41 (63.4) (48.7–78.2) | 21/42 (50.0) (34.9–65.1) |
| > 5 mg/l | 31/44 (70.5) (57.0–83.9) | 24/48 (50.0) (35.9–64.1) | 25/42 (59.5) (44.7–74.4) | 25/44 (56.8) (42.2–71.5) |
| Age | ||||
| < 65 yrs | 51/79 (64.6) (54.0–75.1) | 45/77 (58.4) (47.4–69.4) | 46/72 (63.9) (52.8–75.0) | 41/74 (55.4) (44.1–66.7) |
| ≥ 65 yrs | 4/9 (44.4) (12.0–76.9) | 3/11 (27.3) (1.0–53.6) | 5/11 (45.5) (16.0–74.9) | 5/12 (41.7) (13.8–69.6) |
| Sex | ||||
| Male | 16/24 (66.7) (47.8–85.5) | 9/15 (60.0) (35.2–84.8) | 14/18 (77.8) (58.6–97.0) | 10/14 (71.4) (47.8–95.1) |
| Female | 39/64 (60.9) (49.0–72.9) | 39/73 (53.4) (42.0–64.9) | 37/65 (56.9) (44.9–69.0) | 36/72 (50.0) (38.5–61.5) |
↵a Four weeks postvaccination.
↵b Absence of effective antibody titers at baseline was defined as < 1.6 μg/ml in ≥ 3 of the 6 pneumococcal antigens assessed, and < 1:40 in ≥ 2 of the 3 influenza antigens assessed.
↵c CRP < 5 mg/l is the central laboratory normal value. CRP: C-reactive protein; PBO: placebo; CZP: certolizumab pegol; DMARD: disease-modifying antirheumatic drug; MTX: methotrexate.