Table 1

Baseline disease characteristics and clinical response rates for the intention-to-treat and the per-protocol groups

Baseline characteristicsIntention-to-treat (n = 52)Per-protocol (n = 35)p Value
Female subjects (%)67570.03
Age (years)61 (50–70)61 (46–68)NS
Disease duration (years)7 (3–13)8 (3–15)NS
Number of previous DMARDs2 (1–3)3 (2–3)NS
Methotrexate (mg/week)19 (13–25)18 (15–25)NS
Concomitant prednisolone (%)2937NS
IgM-RF positive (%)7974NS
DAS28 (3V)-CRP4.7 (4.1–5.5)4.8 (4.1–5.6)NS
Tender joints (28)9 (3–14)7 (3–13)NS
Swollen joints (28)8 (5–10)8 (6–13)NS
CRP (mg/l)21 (7–35)23 (7–40)NS
HAQ1.125 (0.875–1.625)1.125 (0.500–1.625)NS
Sharp/van der Heijde total score (range 0–448)42 (24–79)41 (25–84)NS
CT erosion score (range 0–230)19 (10–33)20 (10–33)NS
CT erosion volume (mm3)46 (12–147)61 (9–171)NS
Clinical response rates*
ACR20 at 6/12 months (%)58/5477/770.001/0.001
ACR50 at 6/12 months (%)42/4057/600.002/0.001
ACR70 at 6/12 months (%)25/3337/490.002/0.001
EULAR good response at 6/12 months (%)35/4651/660.001/0.001
DAS28 remission at 6/12 months (%)†35/4246/540.03/0.02
  • Values are given as median (interquartile range) and percentage for proportions.

  • p Value comparison between completers (n = 35) and non-completers (n = 17).

  • *For response rates in the ITT analysis, people excluded from the study were considered as non-responders and as not in DAS28 remission; †DAS28 remission defined as DAS28 <2.6.

  • ACR, American College of Rheumatology; CRP, C-reactive protein; CT, computed tomography; DAS, Disease Activity Score; DMARDs, disease-modifying antirheumatic drugs; EULAR, European League Against Rheumatism; HAQ, Health Assessment Questionnaire; IgM-RF, IgM rheumatoid factor; NS, not significant.