Intention-to-treat analysis: changes in disease activity indices, markers of inflammation and cardiovascular risk factors over 6 months. Data are mean ± SD or median (interquartile range).
| Methotrexate Alone, n = 20 | Methotrexate + Infliximab, n = 20 | p* | |||
|---|---|---|---|---|---|
| Measure | Baseline | Changes After 6 Months | Baseline | Changes After 6 Months | |
| Disease activity indices and markers of inflammation | |||||
| EMS, min | 45 (15, 120) | −17.5 (−93.8, 0.0) | 45 (16, 113) | −23.5 (−57.5, 2.3) | 0.645 |
| Pain, VAS 0–10 | 6.3 ± 2.4 | −2.1 ± 2.6 | 7.1 ± 2.1 | −3.7 ± 2.5 | 0.062 |
| PtGA, VAS 0–10 | 5.6 ± 2.6 | −0.8 ± 3.2 | 7.1 ± 2.3 | −3.6 ± 2.9 | 0.006 |
| PhGA, VAS 0–10 | 7.0 (5.3, 9.0) | −3.0 (−4.9, 0.0) | 7.0 (6.0, 8.0) | −4.0 (−5.9, −3.3) | 0.091 |
| TJC | 9.9 ± 6.3 | −4.2 ± 5.0 | 9.8 ± 3.8 | −4.9 ± 5.0 | 0.685 |
| SJC | 5.0 (4.0, 7.0) | −2.0 (−4.0, 0.75) | 5.0 (4.6, 8.0) | −4.0 (−5.8, −3.0) | 0.042 |
| DAS28 | 4.6 ± 0.7 | −1.0 ± 1.3 | 5.1 ± 0.7# | −2.0 ± 0.9 | 0.010 |
| HAQ | 1.1 ± 0.7 | −0.3 ± 0.6 | 1.5 ± 0.7 | −0.6 ± 0.5 | 0.078 |
| ESR, mm/h | 55 ± 38 | 13 ± 22 | 65 ± 30 | −22 ± 23 | 0.217 |
| CRP, mg/l | 13.7 (9.8, 21.9) | −6.6 (−14.5, −0.95) | 23.6 (7.7, 36.8) | −17.7 (−29.1, −6.3) | 0.007 |
| Cardiovascular risk factors | |||||
| Glucose, mmol/l | 5.1 ± 0.7 | 0.1 ± 0.3 | 4.9 ± 0.6 | −0.0 ± 0.3 | 0.119 |
| TG, mmol/l | 1.0 ± 0.5 | 0.1 ± 0.3 | 1.1 ± 0.7 | 0.1 ± 0.5 | 0.881 |
| TC, mmol/l | 4.3 ± 1.3 | 0.3 ± 0.8 | 4.5 ± 0.9 | 0.3 ± 0.6 | 0.982 |
| HDL-C, mmol/l | 1.4 ± 0.3 | 0.1 ± 0.2 | 1.4 ± 0.4 | 0.1 ± 0.3 | 1.000 |
| LDL-C, mmol/l | 2.5 ± 1.1 | 0.1 ± 0.6 | 2.6 ± 0.8 | 0.3 ± 0.4 | 0.119 |
| TC/HDL-C | 3.3 ± 0.8 | 0.1 ± 0.6 | 3.4 ± 0.8 | 0.1 ± 0.7 | 0.565 |
| SBP, mm Hg | 130 ± 24 | −3 ± 15 | 129 ± 16 | −4.2 ± 13.4 | 0.786 |
| DBP, mm Hg | 80 ± 13 | −4.4 ± 10.0 | 79 ± 10 | −1.5 ± 11.1 | 0.380 |
| BMI, kg/m2 | 22.3 ± 3.1 | 0.2 ± 0.8 | 22.0 ± 3.5 | 0.1 ± 0.8 | 0.664 |
↵* Comparison between the changes from baseline between the 2 groups using Student t tests or Mann-Whitney U tests. EMS: duration of early morning stiffness; VAS: visual analog scale; PtGA: patient’s global assessment; PhGA: physician’s global assessment; DAS28: 28-joint Disease Activity Score; HAQ: Health Assessment Questionnaire; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein; TG: total triglyceride; TC: total cholesterol; HDL-C: high-density lipoprotein cholesterol; LDL-C: low-density lipoprotein cholesterol; SBP: systolic blood pressure; DBP: diastolic blood pressure; BMI: body mass index; TJC: tender joint count; SJC: swollen joint count.