Table 1.
Baseline patient characteristics (per-protocol set)
| Parameter | Total (n=136) | cDMARD+anti-TNF (n=45) | Multiple cDMARDs (n=91) | p-valuea |
|---|---|---|---|---|
| Patient demographics | ||||
| Age (years) | 56.47±11.90 | 54.88±12.41 | 57.26±11.63 | 0.274 |
| Age <65 years | 105 (77.21) | 35 (77.78) | 70 (76.92) | >0.999 |
| Female | 100 (73.53) | 35 (77.78) | 65 (71.43) | 0.560 |
| Outpatient | 135 (99.26) | 44 (97.78) | 91 (100.00) | 0.331 |
| BMI (kg/m2) | 23.76±3.68b | 23.78±3.71c | 23.74±3.69d | 0.955 |
| Disease characteristics | ||||
| Duration of RA (days) | 454.94±272.16 | 432.24±243.04 | 466.16±286.08 | 0.496 |
| Total 2010 ACR/EULAR score | 7.99±1.19 | 8.07±1.07 | 7.96±1.25 | 0.612 |
| Joint involvement scoree | 3.51±1.19 | 3.36±1.00 | 3.58±1.27 | 0.607 |
| Serology scoref | 2.60±0.95 | 2.76±0.68 | 2.52±1.06 | 0.189 |
| Acute phase reactant scoreg | 0.92±0.27 | 0.96±0.21 | 0.90±0.30 | 0.221 |
| Symptom duration scoreh | 0.97±0.17 | 1.00±0.00 | 0.96±0.21 | 0.044* |
| CRP (mg/L) | 12.46±18.06 | 15.53±18.53 | 10.95±17.72 | 0.164 |
| ESR (mm/h) | 40.21±26.07 | 51.18±30.86 | 34.79±21.55 | 0.002* |
| Baseline effectiveness outcomes | ||||
| DAS28-ESR score | 5.05±1.00 | 5.62±0.89 | 4.77±0.93 | <0.001* |
| KHAQ-20 score | 0.71±0.74 | 0.95±0.87 | 0.59±0.63 | 0.013* |
Values are presented as mean±standard deviation or number (%). Percentages are based on the number of patients in each treatment group. aTwo-sample t-test or Wilcoxon’s rank-sum test or Pearson’s chi-square test or Fisher’s exact test. *Statistically significant at a 5% significance level, two-tailed test. bn=131. cn=42. d n=89. eScored as follows: 0=1 large joint; 1=2~10 large joints; 2=1~3 small joints (±large joint involvement); 3=4~10 small joints (±large joint involvement); 5=>10 joints (≤1 small joints). fScored as follows: 0=RF negative and anti-CCP antibody negative; 1=positive RF or anti-CCP antibody tests with ≤3 higher than normal titer; 3=positive RF or anti-CCP antibody tests with >3 higher than normal titer. gScored as follows: 0=normal CRP and normal ESR; 1=abnormal CRP or abnormal ESR. hScored as follows: 0=<6 weeks; 1=≥6 weeks. cDMARD: conventional disease-modifying anti-rheumatic drug, anti-TNF: anti-tumor necrosis factor agent, BMI: body mass index, RA: rheumatoid arthritis, ACR: American College of Rheumatology, EULAR: European League Against Rheumatism, CRP: C-reactive protein, ESR: erythrocyte sedimentation rate, DAS28-ESR: disease activity score 28-joint count with ESR, KHAQ: Korean Health Assessment Questionnaire, anti-CCP: anti-cyclic citrullinated peptide, RF: rheumatoid factor.