Table 2 Improvement in ACR components and disease activity at weeks 1 and 24: least squares mean change from baseline (mITT population)
Week 1Week 24
Placebo (n = 109)CZP 400 mg (n = 111)p ValuePlacebo (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<0.0010.0−0.7<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<0.0011.7−20.6<0.001
HAQ-DI¶0.04−0.23<0.0010.13−0.36<0.001
Disease activity:
CRP (mg/litre)**1.00.2<0.0011.20.5<0.001
ESR (mm/h)**1.00.7<0.0011.00.80.05
  • 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.