Table 1

Baseline demographics and clinical characteristics (SAF)

Characteristics (unit)BI 695501 (n=324)Humira (n=321)
Mean age, years (SD)53.7 (12.0)53.6 (11.3)
Age, n (%)
 <65 years264 (81.5)275 (85.7)
 ≥65 years60 (18.5)46 (14.3)
Women, n (%)267 (82.4)269 (83.8)
Mean weight, kg (SD)73.1 (16.9)75.1 (17.1)
Mean BMI, kg/m2 (SD)27.0 (5.4)27.9 (6.3)
Race, n (%)
 Asian8 (2.5)6 (1.9)
 Black or African–American6 (1.9)7 (2.2)
 White309 (95.4)304 (94.7)
 Other*1 (0.3)4 (1.2)
Ethnicity, n (%)
 Hispanic or Latino45 (13.9)44 (13.7)
 Not Hispanic or Latino274 (84.6)276 (86.0)
 Not reported5 (1.5)1 (0.3)
Geographical region, n (%)
 Asia6 (1.9)6 (1.9)
 Europe231 (71.3)228 (71.0)
 Latin America25 (7.7)26 (8.1)
 USA62 (19.1)61 (19.0)
Mean duration of RA, years (SD)7.3 (7.2)7.0 (6.8)
Duration of RA category, n (%)
 <2 years87 (26.9)76 (23.7)
 ≥2 years234 (72.2)238 (74.1)
 Missing3 (0.9)7 (2.2)
Patients with autoantibodies, n (%)
 RF-positive281 (86.7)281 (87.5)
 Anti-CCP positive218 (67.3)237 (73.8)
DAS28 and components
 DAS28-ESR, mean (SD)6.6 (0.8)6.6 (0.8)
 ESR, mm/hour, mean (SD)45.5 (19.2)43.2 (18.0)
 HAQ-DI, median (IQR)1.5 (0.8)1.5 (0.9)
 Swollen joint count, mean (SD)17.1 (10.4)15.9 (9.1)
 Tender joint count, mean (SD)25.3 (13.7)24.9 (13.3)
Prior exposure to a biological† agent, n (%)
 Yes85 (26.2)86 (26.8)
 No239 (73.8)235 (73.2)
 Prior cDMARD‡ therapies, mean (SD)2.2 (1.4)2.4 (1.5)
 Mean MTX dose, mg/week (SD)16.3 (3.6)16.8 (3.9)
Patients with ADAs, n (%)
 ADA-positive11 (3.4)21 (6.5)
 Neutralising ADA-positive9 (2.8)16 (5.0)
  • *Not American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander.

  • †Prior biologics included etanercept, tocilizumab, infliximab, certolizumab, rituximab, abatacept and golimumab.

  • ‡Prior cDMARDs included methotrexate, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine and gold.

  • ADA, antidrug antibody; BMI, body mass index; CCP, cyclic citrullinated peptide; cDMARD, conventional disease-modifying anti-rheumatic drug; DAS28, Disease Activity Score 28-joint count; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; n, number of patients per group; RA, rheumatoid arthritis; RF, rheumatoid factor; SAF, safety analysis set.