Table 2 Adjusted mean change and mean percentage improvement from baseline in ACR core components at weeks 4 and 24 (ITT population—LOCF)
ACR core componentsWeek 4Week 24
Placebo + MTX (n = 127)Certolizumab pegol 200 mg + MTX (n = 246)Certolizumab pegol 400 mg + MTX (n = 246)Placebo + MTX (n = 127)Certolizumab pegol 200 mg + MTX (n = 246)Certolizumab pegol 400 mg + MTX (n = 246)
Swollen joint count
    Adjusted mean change (SE)–1.4 (0.6)–9.1 (0.5)–8.9 (0.5)–2.7 (0.7)–13.8 (0.5)–14.2 (0.5)
    Mean percentage improvement (SD)7.6 (28.0)41.7 (32.8)41.4 (30.7)13.3 (43.1)64.2 (35.9)67.8 (29.0)
Tender joint count
    Adjusted mean change (SE)–1.8 (0.9)–10.7 (0.6)–11.3 (0.7)–3.8 (1.0)–17.3 (0.8)–19.5 (0.8)
    Mean percentage improvement (SD)4.4 (27.8)33.4 (40.7)36.0 (29.1)10.5 (40.4)54.8 (45.3)63.6 (29.2)
Physician’s global assessment of arthritis
    Adjusted mean change (SE)–6.5 (1.4)–24.1 (1.1)–21.9 (1.1)–9.2 (1.7)–34.8 (1.3)–35.6 (1.3)
    Mean percentage improvement (SD)5.7 (26.4)34.3 (24.4)30.1 (25.0)12.0 (30.6)52.3 (28.1)52.1 (29.2)
Patient’s global assessment of arthritis
    Adjusted mean change (SE)–2.9 (1.7)–14.6 (1.2)–15.9 (1.3)–4.2 (2.0)–24.5 (1.4)–26.6 (1.5)
    Mean percentage improvement (SD)–8.5 (63.3)18.1 (57.3)22.4 (32.2)–5.8 (61.9)34.2 (46.6)39.3 (37.4)
Patient’s assessment of arthritic pain
    Adjusted mean change (SE)–2.8 (1.6)–14.0 (1.2)–14.9 (1.2)–4.7 (1.9)–23.7 (1.4)–26.1 (1.4)
    Mean percentage improvement (SD)–8.5 (59.3)21.0 (29.9)18.5 (55.1)–8.3 (77.4)35.9 (34.9)37.9 (38.5)
HAQ-DI
    Adjusted mean change (SE)−0.05 (0.03)−0.27 (0.03)−0.28 (0.03)−0.14 (0.04)−0.50 (0.03)−0.50 (0.03)
    Mean percentage improvement (SD)–3.7 (54.6)18.2 (26.5)16.8 (34.3)3.7 (59.4)31.8 (38.5)32.0 (35.1)
CRP, adjusted geometric mean (95% CI) – ratio to baseline0.89 (0.74 to 1.08)0.34 (0.30 to 0.40)0.36 (0.31 to 0.42)0.92 (0.74 to 1.14)0.42 (0.35 to 0.49)0.34 (0.29 to 0.40)
  • p<0.001 for certolizumab pegol 200 mg and 400 mg versus placebo for all ACR core components at weeks 4 and 24 based on adjusted mean change from baseline (ANCOVA with LOCF imputation with region and treatment group as factors and baseline value as covariate).

  • ACR, American College of Rheumatology; ANCOVA, analysis of covariance; CI, confidence interval; CRP, C-reactive protein; HAQ-DI, Health Assessment Questionnaire-Disability Index; ITT, intention-to-treat; LOCF, last observation carried forward; MTX, methotrexate.