Table 1.
Patients’ baseline demographic and clinical characteristics (cITT population)
| Characteristic | Study 1 | Study 2 | ||||
|---|---|---|---|---|---|---|
| 40 mg/0.8 mL to 40 mg/0.4 mL formulation (n = 31) | 40 mg/0.4 mL to 40 mg/0.8 mL formulation (n = 31) | Total (N = 62) | 40 mg/0.8 mL to 40 mg/0.4 mL formulation (n = 31) | 40 mg/0.4 mL to 40 mg/0.8 mL formulation (n = 29) | Total (N = 60) | |
| Sex, n (%) | ||||||
| Female | 21 (67.7) | 21 (67.7) | 42 (67.7) | 24 (77.4) | 23 (79.3) | 47 (78.3) |
| Male | 10 (32.3) | 10 (32.3) | 20 (32.3) | 7 (22.6) | 6 (20.7) | 13 (21.7) |
| Age, y, mean (SD) | 51.1 (12.6)a | 58.6 (13.5)a | 54.8 (13.5) | 58.3 (11.6) | 54.4 (14.1) | 56.4 (12.9) |
| Duration of RAb, y, mean (SD) | 9.3 (7.6)c | 16.8 (9.8)c | 13.0 (9.5) | 11.7 (8.0) | 12.1 (11.3) | 11.9 (9.6) |
| Biologic-naive, n (%) | 10 (32.3) | 9 (29.0) | 19 (30.6) | 10 (32.3) | 7 (24.1) | 17 (28.3) |
| Currently receiving adalimumab for ≥6 consecutive doses, n (%) | 21 (67.7) | 22 (71.0) | 43 (69.4) | 21 (67.7) | 22 (75.9) | 43 (71.7) |
| Injection site pain immediately after injection in the last month, cm, mean (SD)d,e | 4.9 (1.6) | 4.8 (1.4) | 4.8 (1.5) | 5.4 (1.9) | 5.8 (2.0) | 5.6 (1.9) |
| Adalimumab dosing frequencyd, n (%) | ||||||
| Weekly | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (2.3) |
| Every other week | 21 (100) | 22 (100) | 43 (100) | 19 (90.5) | 21 (95.5) | 40 (93.0) |
| Other | 0 | 0 | 0 | 1 (4.8) | 1 (4.5) | 2 (4.7) |
ANOVA analysis of variance, cITT crossover intent-to-treat, RA rheumatoid arthritis, SD standard deviation
a P < 0.05 for difference between sequence groups using one-way ANOVA
bCalculated as (date of first study drug−date of diagnosis of RA)/365.25
c P ≤ 0.001 for difference between sequence groups using one-way ANOVA
dOnly for patients currently receiving adalimumab
eAssessed on a 10-cm visual analog scale at screening (0 cm = no pain; 10 cm = worst possible pain)