Table 1 Baseline characteristics of patients' and comparison of the different outcome measures evaluating the effects of treatment.
| Placebo | Infliximab | Difference between groups | |
|---|---|---|---|
| Baseline characteristics | |||
| Age (years)* | 47 (39–63) | 48 (30–65) | NS |
| Men/women† | 4:5 | 5:4 | NS |
| Disease duration (years)* | 5 (3–26) | 5 (1–18) | NS |
| Patient's global assessment VAS* | 47 (24–97) | 66 (42–84) | NS |
| Physician's global assessment VAS* | 65 (51–77) | 65 (60–85) | NS |
| 66 swollen joint count* | 8 (1–17) | 9 (3–14) | NS |
| 28 swollen joint count* | 4 (1–7) | 5 (1–9) | NS |
| 28 tender joint count* | 5 (1–10) | 4 (1–8) | NS |
| ESR (mm/at the end of the first hour)* | 8 (4–43) | 11 (1–26) | NS |
| CRP (mg/dl)* | 0.8 (0.27–1.51) | 0.96 (0–2.41) | NS |
| DAS28 ‡ | 3.78 (1.16) | 4.32 (1.21) | NS |
| HLA B27 positive/negative† | 3/6 | 2/7 | NS |
| Effects of treatment | |||
| mACR no/20/50/70 responders† | 8/0/1/0 | 0/3/2/3 | γ = 0.861 ±0.142 p = 0.002§ |
| mACR20 responders (no/yes)† | 8/1 | 1/8 | OR 28 (95% CI 2.1 to 379) p = 0.015¶ |
| No/moderate/good DAS28 response† | 7/2/0 | 0/1/7 | γ = 0.944 ±0.067 p = 0.001§ |
| Moderate DAS28 response (no/yes)† | 7/2 | 0/8 | OR 28 (95%CI: 2.1 to379) p = 0.015¶ |
| PsARC response: (no/yes)† | 7/2 | 0/9 | p = 0.002¶ |
| Remaining DAS28 score at week 12* | 3.91 (1.48) | 2.06 (0.84) | p = 0.007** |
| Difference in DAS28 score between baseline and week 12* | +0.127 (0.84) p = NS†† | −2.26 (1.33) p = 0.001†† | |
| Area under the curve | −0.95 | −29.31 | p = 0.006‡‡ |
CRP, C reactive protein; ESR, erythrocyte sedimentation rate; HLA, human leucocyte antigen; NS, not significant; VAS, visual analogue scale.
*Values are the median (range); †Values are number of patients in each category; ‡Values are the mean (SD); §Exact γ statistic; ¶Fisher's exact test; **t test; ††Paired sample t test; ‡‡Mann–Whitney U test;