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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

Parameter

ABP 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 Latino

18 (6.5)

13 (4.7)

31 (5.6)

 Not Hispanic or Latino

261 (93.5)

266 (95.3)

527 (94.4)

Race, n (%)

 White

265 (95.0)

267 (95.7)

532 (95.3)

 Black or African American

12 (4.3)

12 (4.3)

24 (4.3)

 Asian

2 (0.7)

0 (0.0)

2 (0.4)

Region, n (%)

 Asia Pacific

5 (1.8)

4 (1.4)

9 (1.6)

 Europe

220 (78.9)

222 (79.6)

442 (79.2)

 North America

54 (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 years

104 (37.3)

123 (44.1)

227 (40.7)

 ≥ 5 years

175 (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/L

14.26 (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 screening

244 (87.5)

251 (90.0)

495 (88.7)

Anti-CCP status, n (%)

 Positive at screening

253 (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/week

17.54 (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