Table 1

Patient demographics and disease characteristics of the rerandomised population at baseline (A and B) and rerandomisation (C)

VariableINF/SB2 (n=94)INF/INF (n=101)SB2/SB2 (n=201)
A. Demographics at baseline (week 0)
 Age, years53.0±11.051.5±11.251.8±12.1
 Female, n (%)77 (81.9)79 (78.2)158 (78.6)
 Race white, n (%)87 (92.6)88 (87.1)183 (91.0)
 Height, cm165.7±8.0165.4±7.5165.2±9.0
 Weight, kg72.2±14.973.1±17.472.7±14.7
 BMI, kg/m2 26.3±5.126.8±6.426.6±5.0
 Disease duration, years6.3±5.46.7±6.16.3±6.2
 Rheumatoid factor positive, n (%)67 (71.3)66 (65.3)140 (69.7)
B. Disease characteristics at baseline (week 0)
 Tender joint count (0–68)23.7±11.324.6±11.623.9±12.2
 Swollen joint count (0–66)14.6±7.614.3±7.214.1±6.8
 Duration of MTX use, months49.7±45.452.1±50.651.1±46.8
 MTX dose at baseline, mg/week14.3±3.915.2±4.014.7±4.1
 C reactive protein, mg/L13.8±21.913.7±18.812.0±19.1
 ESR, mm/hour45.7±23.045.3±19.743.0±17.5
 HAQ-DI (0–3)1.5±0.61.5±0.51.5±0.6
 Patient pain VAS (0–100), mm60.9±20.466.7±19.060.0±17.9
 Patient VAS (0–100), mm62.8±18.164.3±17.461.7±17.3
 Physician VAS (0–100), mm61.9±16.262.0±14.560.8±15.1
 DAS28 (ESR)6.5±0.76.6±0.86.4±0.8
C. Disease characteristics at rerandomisation (week 54)
 Tender joint count (0–68)6.2±7.08.2±10.57.3±9.2
 Swollen joint count (0–66)2.7±4.44.0±6.13.4±5.2
 C reactive protein, mg/L6.6±12.48.2±12.78.4±12.6
 ESR, mm/hour27.7±21.928.3±19.628.3±20.0
 HAQ-DI (0–3)1.0±0.61.0±0.61.0±0.7
 Patient pain VAS (0–100), mm35.9±23.435.8±22.735.6±23.8
 Patient VAS (0–100), mm35.5±22.635.8±21.934.8±23.3
 Physician VAS (0–100), mm24.5±18.125.0±17.125.1±18.0
 DAS28 (ESR)3.9±1.34.1±1.54.0±1.4
 Infliximab dose, mg/kg3.78±1.163.91±1.383.85±1.25
  • Values represent mean±SD or number (percentage) of patients.

  • BMI, body mass index; CDAI, Clinical Disease Activity Index; DAS28, disease activity score based on a 28-joint count; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire of Disability Index; INF, reference infliximab; MTX, methotrexate; SDAI, simplified disease activity index; VAS, visual analogue scale.