Table 1 Clinical outcome measures, drug doses and disease activity at baseline, after 1 year and after 2 years
Baseline (week 0)Year 1 (week 52)Year 2 (week 104)
MTX + ciclosporineMTX + placebo-ciclosporinep Value*MTX + ciclosporineMTX + placebo-ciclosporinep Value*MTX + CiclosporineMTX + placebo-ciclosporinep Value*
No. of tender joints, range 0–4014 (7–20)14 (8–20)0.480 (0–1)1 (0–5)0.0040 (0–2)1 (0–4)0.23
No. of swollen joints, range 0–4012 (6–14)11 (6–15)0.470 (0–0)0 (0–2)0.110 (0–0)0 (0–1)0.61
Doctor’s global assessment, 0–100 mm VAS54 (37–65)61 (39–71)0.151 (0–7)5 (0–18)0.022 (0–6)3 (0–11)0.68
Patient’s assessment of pain, 0–100 mm VAS46 (28–70)48 (29–65)0.8611 (2–23)15 (5–36)0.138 (3–23)10 (1–29)0.80
Patient’s global assessment, 0–100 mm VAS50 (28–70)52 (32–73)0.3111 (2–27)15 (4–43)0.2012 (2–25)9 (1–34)1.00
Serum CRP, mg/litre21 (10–42)19 (8–46)0.547 (3–10)8 (4–13)0.077 (3–13)7 (4–13)0.61
ESR, mm/h28 (10–48)27 (10–47)0.6713 (7–23)10 (5-23)0.4210 (6–19)10 (4–19)0.28
DAS28 score, ESR based5.4 (4.6–6.1)5.7 (4.7–6.2)0.352.1 (1.6–2.9)2.4 (1.6–3.5)0.332.0 (1.6–3.0)2.2 (1.5–3.2)0.92
HAQ score, range 0–31.0 (0.4–1.5)0.9 (0.5–1.4)0.510.1 (0–0.5)0.4 (0–0.8)0.180 (0–0.4)0.1 (0–0.8)0.17
ACR20, % of patients85680.0288730.04
ACR50, % of patients68530.0879620.03
ACR70, % of patients59440.0859540.6
EULAR remission, % of patients0043340.3351501.00
ACR remission, % of patients0035280.3941350.52
Max. MTX dose, mg/week0012.5 (10–17.5)15 (12.5–20)0.0817.5 (12.5–20)17.5 (12.5–20)
Max. ciclosporine/placebo-ciclosporine dose, mg/kg002.5 (2.5–2.5)2.5 (2.5–2.5)2.5 (2.5–2.5)2.5 (2.5–3.0)
Cumulated dose of intra-articular betamethasone, ml009 (6–17)12 (8–18)0.091.5 (0–5.125)2 (0–7.25)0.18
Blood pressure, mmHg130/80 (120–140/78–88)130/80 (120–139/72–85)0.14–0.35135/82 (120–140/77–88)127/81 (117–140/75–88)0.10–0.63130/81 (120–140/74–86)131/80 (120–140/77–86)0.69–0.71
Serum creatinine, μmol/litre (mean (SD))75.4 (11.0)75.3 (12.2)0.9081.5 (13.6)76.0 (14.1)0.00681.0 (13.7)78.5 (12.9)0.09
  • Values are median (interquartile range) unless otherwise stated.

  • *Mann–Whitney U test for non-dichotomous variables, χ2 test for dichotomous variables.

  • ACR, American College of Rheumatology; CRP, C-reactive protein; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; HAQ, Health Assessment Questionnaire; MTX, methotrexate; VAS, visual analogue scale.