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Table 1 Characteristics of patients at baseline and clinical response at week 54 in each dosing group

From: High titers of both rheumatoid factor and anti-CCP antibodies at baseline in patients with rheumatoid arthritis are associated with increased circulating baseline TNF level, low drug levels, and reduced clinical responses: a post hoc analysis of the RISING study

  3 mg/kg 6 mg/kg 10 mg/kg p Value
At baseline (week 0) (n = 99) (n = 104) (n = 104)  
 Age, years 49.7 (11.7) 48.8 (11.8) 50.4 (12.5) 0.5370
 Female sex 78 (79%) 86 (83%) 89 (86%) 0.4446a
 Disease duration, years 8.3 (7.8) 7.2 (7.1) 8.4 (7.7) 0.4114
 MTX dose, mg/week 7.8 (1.6) 7.9 (1.9) 7.7 (1.7) 0.6510
 DAS28-CRP 5.59 (4.89, 6.31) 5.38 (4.85, 6.36) 5.50 (5.10, 6.11) 0.8026
 TNF, pg/ml 0.92 (< 0.55, 1.29) 0.97 (0.70, 1.31) 0.89 (< 0.55, 1.24) 0.1320
 RF
  Median (IQR), IU/ml 128 (27, 280) 82 (37, 273) 89 (43, 187) 0.6361
  Range (minimum, maximum), IU/ml < 3, 1700 < 3, 2340 < 3, 1950  
  Negative (≤ 15 IU/ml) 19 (19%) 14 (13%) 8 (8%) 0.0551a
 Anti-CCP
  Median (interquartile range), U/ml ≥ 100 (26, ≥ 100) ≥ 100 (23, ≥ 100) ≥ 100 (37, ≥ 100) 0.1308
  Range (minimum, maximum), U/ml < 0.6, ≥ 100 < 0.6, ≥ 100 < 0.6, ≥ 100  
  Negative (≤ 5.0 U/ml) 9 (9%) 12 (12%) 4 (4%) 0.1171a
At week 54 (n = 99) (n = 104) (n = 104)  
 DAS28-CRP at week 54 3.02 (2.13, 4.25) 2.72 (1.59, 3.99) 2.52 (1.69, 3.65) 0.0394
  REM/LDA/MDA/HDA 30 (30%)/11 (11%)/27 (27%)/31 (31%) 41 (39%)/10 (10%)/29 (28%)/24 (23%) 47 (45%)/9 (9%)/31 (30%)/17 (16%) 0.0384
 RF, IU/ml 61 (6, 152) 38 (8, 91) 42 (9, 76) 0.3386
 Anti-CCP, U/ml ≥ 100 (12, ≥ 100) 47 (12, ≥ 100) ≥ 100 (24, ≥ 100) 0.1079
  1. Abbreviations: CCP, Cyclic citrullinated peptide antibodies, DAS28-CRP Disease Activity Score in 28 joints based on C-reactive protein, HDA high disease activity, LDA Low disease activity without clinical remission, MDA Moderate disease activity, MTX Methotrexate, REM Clinical remission, RF Rheumatoid factor, TNF Tumor necrosis factor
  2. Data are mean (SD), median (interquartile range), or number (%), unless otherwise described. The Kruskal-Wallis test was used to evaluate the differences among three dosing groups, except where indicated otherwise. Disease activity, RF, and anti-CCP at Week 54 were evaluated using the last observation carried forward approach. Cutoff values for DAS28-CRP were as follows: REM, <2.3; LDA, ≥2.3– < 2.7; MDA, ≥2.7– ≤ 4.1; HDA, > 4.1 [22]
  3. aChi-square test was used to evaluate the differences among three dosing-groups