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Table 1 Summary of demographic data and baseline characteristics

From: Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis

ParameterABP 710 (n = 279)Infliximab RP (n = 279)Total (n = 558)
Mean age, years (range)55.0 (23, 77)54.8 (19, 77)54.9 (19, 77)
Women, n (%)214 (76.7)223 (79.9)437 (78.3)
Ethnicity, n (%)
 Hispanic or Latino18 (6.5)13 (4.7)31 (5.6)
 Not Hispanic or Latino261 (93.5)266 (95.3)527 (94.4)
Race, n (%)
 White265 (95.0)267 (95.7)532 (95.3)
 Black or African American12 (4.3)12 (4.3)24 (4.3)
 Asian2 (0.7)0 (0.0)2 (0.4)
Region, n (%)
 Asia Pacific5 (1.8)4 (1.4)9 (1.6)
 Europe220 (78.9)222 (79.6)442 (79.2)
 North America54 (19.4)53 (19.0)107 (19.2)
Mean duration of RA, years (range)8.72 (0.3, 45.0)8.34 (0.3, 39.0)8.53 (0.3, 45.0)
Duration of RA category, n (%)
 < 5 years104 (37.3)123 (44.1)227 (40.7)
 ≥ 5 years175 (62.7)156 (55.9)331 (59.3)
Swollen joint count, mean (SD)14.6 (8.05)14.7 (8.83)14.7 (8.44)
Tender joint count, mean (SD)23.1 (12.16)23.8 (13.38)23.4 (12.78)
Subject Global Health Assessment, mean (SD)65.4 (18.13)64.1 (20.03)64.7 (19.10)
Investigator Global Health Assessment, mean (SD)64.5 (15.88)64.1 (15.76)64.3 (15.81)
HAQ-DI, mean (SD)1.44 (0.584)1.42 (0.617)1.43 (0.601)
Serum CRP, mean (SD), mg/L14.26 (20.171)14.64 (23.117)14.45 (21.675)
DAS28-CRP, mean (SD)5.58 (0.912)5.60 (0.893)5.59 (0.902)
RF status, n (%)
 Positive at screening244 (87.5)251 (90.0)495 (88.7)
Anti-CCP status, n (%)
 Positive at screening253 (90.7)253 (90.7)506 (90.7)
Prior biologic use for RA, n (%)77 (27.6)81 (29.0)158 (28.3)
MTX dose, mean (SD), mg/week17.54 (4.835)17.19 (4.938)17.36 (4.886)
  1. Abbreviations: CCP cyclic citrullinated peptide, CRP C-reactive protein, DAS28 Disease Activity Score 28-joint count, HAQ-DI Health Assessment Questionnaire Disability Index, MTX methotrexate, RA rheumatoid arthritis, RF rheumatoid factor, RP reference product, SD standard deviation