Characteristics at the start of the study and reasons for withdrawal during the study
| I-group* | C-group* | |||
|---|---|---|---|---|
| N | Value | N | Value | |
| Demographic variables (mean±SD) | ||||
| Age (years) | 149 | 54±14 | 140 | 52±15 |
| Gender (% female) | 149 | 68.5% | 140 | 65.0% |
| BMI (kg/m2) | 107 | 25±4 | 104 | 26±4 |
| Clinical variables (mean±SD) | ||||
| Swollen joint count (number) | 149 | 14±6 | 138 | 14±6 |
| Tender joint count (number) | 148 | 15±7 | 137 | 14±7 |
| VAS pain (mm) | 143 | 53±26 | 135 | 47±25 |
| VAS general wellbeing (mm) | 146 | 54±22 | 135 | 52±22 |
| Functional disability (HAQ) | 119 | 1.30±0.7 | 109 | 1.25±0.7 |
| Laboratory values (mean±SD) | ||||
| ESR (mm/h 1st) | 148 | 37±27 | 138 | 39±25 |
| Male | 47 | 31±27 | 48 | 36±26 |
| Female | 101 | 40±27 | 90 | 40±24 |
| Hb (mmol/l) | 148 | 8.0±0.8 | 140 | 8.0±0.8 |
| Male | 47 | 8.6±0.7 | 49 | 8.5±0.7 |
| Female | 101 | 7.8±0.7 | 91 | 7.7±0.7 |
| Creatinine (µmol/l) | 146 | 74±14 | 138 | 73±13 |
| Male | 46 | 84±11 | 49 | 83±12 |
| Female | 100 | 70±12 | 89 | 68±11 |
| Creatinine clearance (ml/min) | 136 | 98±27 | 131 | 101±28 |
| Male | 43 | 103±30 | 44 | 111±26 |
| Female | 93 | 95±26 | 87 | 96±28 |
| AST (U/l) | 145 | 23±8 | 135 | 23±8 |
| Male | 45 | 24±7 | 48 | 24±8 |
| Female | 100 | 23±8 | 87 | 23±8 |
| ALT (U/l) | 147 | 22±13 | 139 | 21±12 |
| Male | 46 | 25±12 | 49 | 21±9 |
| Female | 101 | 21±13 | 90 | 20±13 |
| Rheumatoid factor (% positive) | 134 | 66.4 | 124 | 63.7 |
| Medical history (N) | ||||
| Diabetes mellitus | 4 | 4 | ||
| Hypertension | 69 | 67 | ||
| Grade 1 | 40 | 36 | ||
| Grade 2 | 18 | 22 | ||
| Grade 3 | 11 | 9 | ||
| Cardiovascular diseases | 7 | 10 | ||
| COPD | 6 | 6 | ||
| Reasons for withdrawal (N) | ||||
| MTX toxicity | 16 | 8 | ||
| Ciclosporin toxicity | 10 | 1 | ||
| Loss of efficacy | 13 | 4 | ||
| Other or unknown | 18 | 14 | ||
| Ciclosporin use during follow-up (N) | 39 | 7 | ||
| NSAID use at baseline (N) | 116 | 110 | ||
Values are mean±SD or percentages.
↵* C-group, conventional treatment strategy group; I-group, intensive treatment strategy group.
ALT, serum alanine aminotransferase; AST, serum aspartate aminotransferase; BMI, body mass index, COPD, chronic obstructive pulmonary disease; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire (0–3, most functional disability); Hb, haemoglobin; MTX, methotrexate; N, number of patients with available data; NSAID, non-steroidal anti-inflammatory drug; VAS, visual analogue scale pain and general wellbeing (range 0–100 mm, worst score).