Week 1 | Week 24 | |||||
Placebo (n = 109) | CZP 400 mg (n = 111) | p Value | Placebo (n = 109) | CZP 400 mg (n = 111) | p Value | |
ACR core component scores: | ||||||
Swollen joint count* | −2.8 | −6.0 | <0.001 | −6.3 | −11.6 | <0.001 |
Tender joint count† | −4.6 | −9.8 | <0.001 | −7.3 | −16.0 | <0.001 |
Patient's Global Assessment of Arthritis‡ | −0.1 | −0.5 | <0.001 | 0.0 | −0.7 | <0.001 |
Physician's Global Assessment of Arthritis‡ | −0.1 | −0.7 | <0.001 | −0.2 | −1.1 | <0.001 |
Patient’s assessment of arthritis pain (VAS)§ | −5.2 | −16.7 | <0.001 | 1.7 | −20.6 | <0.001 |
HAQ-DI¶ | 0.04 | −0.23 | <0.001 | 0.13 | −0.36 | <0.001 |
Disease activity: | ||||||
CRP (mg/litre)** | 1.0 | 0.2 | <0.001 | 1.2 | 0.5 | <0.001 |
ESR (mm/h)** | 1.0 | 0.7 | <0.001 | 1.0 | 0.8 | 0.05 |
From analysis of covariance model with treatment and country as factors and baseline value as covariate. This table is based on the last observation carried forward approach. The reported changes for CRP at week 24 correspond to an actual decrease from baseline of −5.2 mg/litre for the certolizumab pegol arm and an increase of +2.2 mg/litre for the placebo arm, respectively.
*Scale ranged from 0 to 66, with negative change indicating improvement; †scale ranged from 0 to 68, with negative change indicating improvement; ‡scale ranged from 1 to 5, with negative change indicating improvement; §scale ranged from 0 to 100, with negative change indicating improvement; MCID = −10; ¶scale ranged from 0 to 3, with negative change indicating improvement; MCID = −0.22; **based on log-transformed data for CRP and ESR.
ACR, American College of Rheumatology; CRP, C-reactive protein; CZP, certolizumab pegol; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; MCID, minimal clinically important difference; mITT, modified intention to treat; VAS, visual analogue scale.