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 years | 4382 (38.7) | 1609 (23.2) | 203 (64.4) | 154 (39.2) | 529 (47.6) | 1887 (73.4) |
| ≥45 to <65 years | 5575 (49.3) | 4131 (59.6) | 104 (33.0) | 214 (54.5) | 505 (45.4) | 621 (24.2) | |
| ≥65 years | 1354 (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 America | 4098 (36.2) | 2784 (40.2) | 82 (26.0) | 94 (23.9) | 360 (32.4) | 778 (30.3) |
| Western and Central Europe | 4698 (41.5) | 2332 (33.7) | 202 (64.1) | 242 (61.6) | 752 (67.6) | 1170 (45.5) | |
| Eastern Europe | 840 (7.4) | 594 (8.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 246 (9.6) | |
| Asia | 371 (3.3) | 195 (2.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 176 (6.8) | |
| Japan | 860 (7.6) | 771 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 89 (3.5) | |
| Latin America | 365 (3.2) | 251 (3.6) | 31 (9.8) | 57 (14.5) | 0 (0.0) | 26 (1.0) | |
| South Africa | 85 (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/m2 | 4804 (42.4) | 2661 (38.4) | 112 (35.6) | 90 (22.9) | 237 (21.3) | 1704 (66.3) |
| ≥25 to <30 kg/m2 | 3349 (29.6) | 2149 (31.0) | 105 (33.3) | 144 (36.6) | 408 (36.7) | 543 (21.1) | |
| ≥30 kg/m2 | 3136 (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-2007 | 4602 (40.7) | 2367 (34.2) | 0 | 0 | 117 (10.5) | 2118 (82.4) |
| 2007 onwards | 6715 (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.