Table 1

Population baseline characteristics for CZP-treated patients (all doses) in the combined RCT and OLE periods (RCT+OLE)

Overall
(n=11 317;
21 695 PY)
RA
(n=6927;
13 542 PY)
axSpA
(n=315;
978 PY)
PsA
(n=393;
1316 PY)
PSO
(n=1112;
1481 PY)
CD
(n=2570;
4378 PY)
Mean age, years (SD)48.1 (13.9)53.0 (12.2)39.8 (11.9)47.7 (11.3)45.4 (13.0)37.1 (12.2)
Age category,
n (%)
≥18 to <45 years4382 (38.7)1609 (23.2)203 (64.4)154 (39.2)529 (47.6)1887 (73.4)
≥45 to <65 years5575 (49.3)4131 (59.6)104 (33.0)214 (54.5)505 (45.4)621 (24.2)
≥65 years1354 (12.0)1187 (17.1)8 (2.5)25 (6.4)78 (7.0)56 (2.2)
Female, n (%)7637 (67.5)5491 (79.3)119 (37.8)218 (55.5)373 (33.5)1436 (55.9)
Female ≥18 to <45 years, n (%)2705 (23.9)1345 (19.4)80 (25.4)78 (19.8)169 (15.2)1033 (40.2)
Geographic region, n (%)North America4098 (36.2)2784 (40.2)82 (26.0)94 (23.9)360 (32.4)778 (30.3)
Western and Central Europe4698 (41.5)2332 (33.7)202 (64.1)242 (61.6)752 (67.6)1170 (45.5)
Eastern Europe840 (7.4)594 (8.6)0 (0.0)0 (0.0)0 (0.0)246 (9.6)
Asia371 (3.3)195 (2.8)0 (0.0)0 (0.0)0 (0.0)176 (6.8)
Japan860 (7.6)771 (11.1)0 (0.0)0 (0.0)0 (0.0)89 (3.5)
Latin America365 (3.2)251 (3.6)31 (9.8)57 (14.5)0 (0.0)26 (1.0)
South Africa85 (0.8)0 (0.0)0 (0.0)0 (0.0)0 (0.0)85 (3.3)
Mean BMI, kg/m2 (SD)27.2 (6.7)27.8 (6.6)27.6 (5.9)29.8 (6.5)30.1 (6.9)24.0 (5.5)
BMI class,
n (%)
<25 kg/m24804 (42.4)2661 (38.4)112 (35.6)90 (22.9)237 (21.3)1704 (66.3)
≥25 to <30 kg/m23349 (29.6)2149 (31.0)105 (33.3)144 (36.6)408 (36.7)543 (21.1)
≥30 kg/m23136 (27.7)2096 (30.3)93 (29.5)158 (40.2)467 (42.0)322 (12.5)
Mean disease duration, years (SD)8.1 (8.7)6.4 (6.9)6.8 (7.5)8.6 (8.3)18.4 (12.3)8.5 (8.1)
Baseline systemic steroid use, n (%)4132 (36.5)3200 (46.2)160 (50.8)99 (25.2)37 (3.3)636 (24.7)
Baseline MTX use, n (%)5782 (51.1)5435 (78.5)55 (17.5)250 (63.6)1 (0.1)41 (1.6)
Prior anti-TNF use, n (%)2515 (22.2)1283 (18.5)49 (15.6)75 (19.1)148 (13.3)960 (37.4)
Date of treatment initiation, n (%)*Pre-20074602 (40.7)2367 (34.2)00117 (10.5)2118 (82.4)
2007 onwards6715 (59.3)4560 (65.8)315 (100.0)393 (100.0)995 (89.5)452 (17.6)
  • *Before 2007, the threshold for a positive result on the PPD tuberculin skin test varied (from ≥5 to ≥20 mm) according to geographic region. Since 2007, CZP recommendations internationally mandate that all patients with PPD ≥5 mm receive treatment for latent tuberculosis infection. North America: Canada, USA; Western and Central Europe: Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, Netherlands, UK; Eastern Europe: Belarus, Croatia, Georgia, Israel, Romania, Russia, Serbia, Ukraine; Asia: Australia, Hong Kong, Republic of Korea, New Zealand, Singapore; Latin America: Argentina, Brazil, Chile, Colombia, Mexico.

  • axSpA, axial spondyloarthritis; BMI, body mass index; CD, Crohn’s disease;CZP, certolizumab pegol; MTX, methotrexate; OLE, open-label extension; PPD, purified protein derivative; PsA, psoriatic arthritis; PSO, psoriasis; PY, patient-years; RA, rheumatoid arthritis; RCT, randomised controlled trial; TNF, tumour necrosis factor.