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Table 1 Demographics and disease characteristics at baseline of the double-blind phase (OL set)

From: Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population

  OL set
  Placebo → CZPa CZP → CZPa
(n = 184) (n = 770)
Age (years), mean (SD) 53.7 (12.7) 55.3 (12.3)
Gender, % female 79.3 77.9
Disease duration (years), mean (SD)b 8.9 (9.0) 8.5 (8.7)
Disease duration <2 years, n (%) 45 (24.5) 184 (23.9)
Tender joint count, mean (SD) 14.7 (6.4)(n=184) 14.7 (6.5)(n=769)
Swollen joint count, mean (SD) 11.1 (5.1)(n=184) 11.8 (5.5)(n=769)
DAS28(CRP), mean (SD) 5.7 (0.8)(n=183) 5.7 (0.9)(n=768)
DAS28(ESR) 6.4 (0.8)(n=183) 6.4 (0.9)(n=767)
 <3.2, n (%) 0 0
 3.2–5.1, n (%) 11 (6.0) 68 (8.9)
 >5.1, n (%) 172 (94.0) 699 (91.1)
HAQ-DI, mean (SD) 1.6 (0.6) 1.5 (0.6)
CRP (mg/L), median (min, max) 10.0 (2.9, 159.0) 9.0 (1.0, 164.0)
Rheumatoid factor positive (≥14 IU/mL), n (%) 127 (77.0)(n=165) 505 (73.9)(n=683)
Treatment history, n (%)   
 Prior DMARD use 115 (62.5) 514 (66.8)
 Prior anti-TNF 71 (38.6) 286 (37.1)
 Prior anti-TNF/other biological use 76 (41.3) 309 (40.1)
 Other prior medicationsc 51 (27.7) 209 (27.1)
Concomitantd medications   
 DMARDs 152 (82.6) 649 (84.3)
 MTX 128 (69.6) 533 (69.2)
 Other medicationsc 184 (100) 768 (99.7)
  1. OL open-label, CZP certolizumab pegol, DAS28 Disease Activity Score in 28 joints, CRP C-reactive protein, ESR erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire-Disability Index, DMARD disease-modifying antirheumatic drug, TNF tumor necrosis factor, MTX methotrexate
  2. aPatients who completed 12 weeks of treatment with either CZP 200 mg every other week (Q2W) or placebo during the double-blind phase entered the OL phase and subsequently received active treatment (CZP 200 mg Q2W)
  3. bDuration at screening visit
  4. cMedications other than DMARDs, anti-TNFs or other biologics, including those for treatment of comorbidities
  5. dConcomitant medications include those ongoing at the week 12 visit or taken during the OLE phase