Table 3.
Assessment, mean (SD) | 40 mg/0.8 mL formulation | 40 mg/0.4 mL formulation | Within-patient differencea (95% CI) | P valueb |
---|---|---|---|---|
Study 1 | N = 62 | N = 62 | ||
Pain of injection | 1.0 (1.52) | 0.9 (1.66) | –0.09 (–0.40 to 0.23) | 0.581 |
Present pain intensity | 0.3 (0.54) | 0.2 (0.48) | –0.05 (–0.22 to 0.13) | 0.584 |
MPQ-SF pain experience | ||||
Sensory dimension score | 0.8 (1.83) | 0.6 (2.14) | –0.13 (–0.73 to 0.48) | 0.671 |
Affective dimension score | 0.1 (0.65) | 0.1 (0.58) | –0.03 (–0.24 to 0.17) | 0.754 |
Total score | 0.9 (2.32) | 0.7 (2.64) | –0.16 (–0.93 to 0.61) | 0.678 |
Study 2 | N = 60 | N = 60 | ||
Pain of injection | 1.0 (1.61) | 0.4 (1.08) | –0.62 (–1.08 to –0.17) | 0.008 |
Present pain intensity | 0.7 (0.86) | 0.2 (0.53) | –0.42 (–0.62 to –0.22) | <0.001 |
MPQ-SF pain experience | ||||
Sensory dimension score | 1.5 (2.84) | 0.4 (0.92) | –1.17 (–1.81 to –0.52) | <0.001 |
Affective dimension score | 0.1 (0.25) | 0.1 (0.36) | 0 (–0.09 to 0.10) | 0.963 |
Total score | 1.6 (2.88) | 0.5 (1.03) | –1.17 (–1.81 to –0.52) | <0.001 |
ANOVA analysis of variance, CI confidence interval, MPQ-SF short-form McGill Pain Questionnaire, SD standard deviation
aWithin-patient difference for 40 mg/0.4 mL adalimumab–40 mg/0.8 mL adalimumab from the crossover ANOVA model with period, sequence, and treatment as fixed effects, and subject as a random effect
bFor differences between treatment groups from ANOVA with period, sequence, and treatment as fixed effects, and subject as a random effect