Table 4.

Benefit-risk analysis.

Area A, n = 90Area I, n = 335p
Sex, female, n (%)19 (21.11)98 (29.25)0.125a
Weight, kg, mean (SD)55.4 (9.6)52.3 (10.7)0.014b
Age, yrs, mean (SD)51.7 (14.8)68.1 (8.2)< 0.001b
Duration of illness, yrs, mean (SD)3.1 (3.8)13.9 (9.5)< 0.001b
Disease stage by Steinbrocker, n (%)
  I41 (45.56)10 (2.99)< 0.001a
  II41 (45.56)60 (17.91)
  III5 (5.56)110 (32.84)
  IV3 (3.33)155 (46.27)
Function class by Steinbrocker, n (%)
  150 (55.56)15 (4.48)< 0.001a
  240 (44.44)177 (52.84)
  30136 (40.60)
  407 (2.09)
Comorbidities
  Any comorbidities37 (41.11)318 (94.93)< 0.001a
  Respiratory disease9 (10.00)173 (51.64)< 0.001a
  Cardiac functional disorders2 (2.22)47 (14.03)0.002a
  Liver disorders8 (8.89)23 (6.87)0.512a
  Renal dysfunction1 (1.11)23 (6.87)0.036a
Concomitant drug usec
  DMARD59 (65.56)216 (64.48)0.849a
  MTX47 (52.22)110 (32.84)< 0.001a
  Corticosteroids (oral only)13 (14.44)335 (100.00)< 0.001a
Pervious medication use
  Biologic8 (8.89)220 (65.67)< 0.001a
DAS28-ESR, mean (SD)3.39 (0.87)5.94 (1.20)< 0.001b
  • a Chi-squared test results.

  • b t test results.

  • c Concomitant use at any timepoint during the observation period including baseline. DAS28-ESR: Disease Activity Score based on 28-joint-erythrocyte sedimentation rate; DMARD: disease-modifying antirheumatic drugs; MTX: methotrexate.