Table 1

Patient characteristics at baseline: safety set

Placebo→CZP (n=13)CZP (n=27)All patients (N=40)
Demographic characteristics: mean (SD), unless noted
 Age, years48.3 (14.4)51.3 (12.6)50.4 (13.1)
 Sex, % female76.981.580.0
 Weight, kg75.9 (30.4)74.0 (18.7)74.6 (22.8)
 Time since diagnosis, years5.9 (5.1)4.8 (3.8)5.1 (4.2)
 Concomitant MTX use, %92.385.287.5
 Prior anti-TNF therapy, %15.422.220.0
Disease characteristics: mean (SD), unless noted
 CRP, mg/L*6.2 (247.5)3.8 (171.0)4.4 (194.9)
 DAS28(CRP)5.3 (1.2)5.1 (1.1)5.1 (1.1)
 IgM rheumatoid factor positive† (%)92.392.692.5
 Anti-CCP positive‡ (%)92.396.395.0
 Tender joint count (28 joints)13.8 (7.4)13.0 (7.8)13.3 (7.6)
 Swollen joint count (28 joints)9.9 (6.3)10.0 (6.4)10.0 (6.3)
 HAQ-DI1.4 (0.5)1.2 (0.6)1.3 (0.6)
 MRI synovitis score§7.4 (5.2)7.3 (5.3)7.4 (5.2)
 MRI osteitis score¶7.1 (7.3)7.2 (9.9)7.2 (9.0)
 MRI bone erosion Score**7.0 (11.0)5.0 (7.2)5.7 (8.5)
  • *Data show geometric mean (geometric coefficient of variation (%)).

  • †Rheumatoid factor positive ≥14 IU/mL.

  • ‡Anti-CCP positive ≥20 ELISA units.

  • §On a scale from 0 to 21.

  • ¶On a scale of 0–69.

  • **On a scale of 0–230.

  • CCP, cyclic citrullinated peptide; CRP, C reactive protein; CZP, certolizumab pegol; DAS, Disease Activity Score; HAQ-DI, Health Assessment Questionnaire-Disability Index; IgM, immunoglobulin M; MTX, methotrexate; TNF, tumour necrosis factor.