Table 2

Results of the separate univariate analyses for each variable, adjusted for age and sex, at 6 and 12 months

Variables6 Months12 Months
OR (95% CI)p ValueOR (95% CI)p Value
Univariate analysis*Disease duration1.0 (0.9 to 1.0)0.281.0 (0.7 to 1.5)0.82
RF (positive vs negative)1.4 (0.9 to 2.0)0.11.5 (1.1 to 2.2)0.02
Anti-CCP (positive vs negative)2.5 (1.4 to 4.5)0.0022.5 (1.4 to 4.4)0.001
Previous DMARD (n)0.8 (0.7 to 0.9)0.0011.0 (0.9 to 1.1)0.36
Previous biological agents (n) (0–1 vs >1)1.8 (1.3 to 2.5)<0.00011.6 (1.2 to 2.2)0.004
Baseline DAS280.8 (0.5 to 1.1)0.171.0 (0.9 to 1.1)0.96
Baseline HAQ0.9 (0.8 to 1.2)0.70.9 (0.6 to 1.0)0.15
Leflunomide plus rituximab vs methotrexate plus rituximab2.1 (1.2 to 3.5)0.0092.0 (1.2 to 3.3)0.005
Leflunomide plus rituximab vs rituximab2.3 (1.2 to 4.1)0.0082.0 (1.2 to 3.5)0.01
Methotrexate plus rituximab vs rituximab1.1 (0.8 to 1.6)0.61.0 (0.7 to 1.5)0.93
Use of glucocorticoids1.3 (1.0 to 1.8)0.061.3 (1.0 to 1.8)0.04
Glucocorticoids dose0.9 (0.9 to 1.0)0.450.9 (0.9 to 1.0)0.02
Country0.0010.002
Multivariate analysisPrevious biological agents (n) (0–1 vs >1)1.5 (0.9 to 2.3)0.05NSNS
Leflunomide plus rituximab2.0 (1.1 to 3.7)0.032.8 (1.0 to 7.9)0.04
Anti-CCP (positive vs negative)NSNS2.2 (1.1 to 4.2)0.02
  • * The dependent variable was EULAR good response at 6 and 12 months, respectively. The combination of leflunomide with rituximab was significantly associated with a good EULAR response compared with the combination of rituximab and methotrexate and rituximab monotherapy. Methotrexate was not associated with good response to therapy compared with rituximab monotherapy.

  • 'Country' was a significant independent variable (but no country on its own was significantly associated with good response to therapy).

  • Multivariate analysis was adjusted for age, sex and country. Concomitant treatment with leflunomide remained significant at both 6 and 12 months.

  • CCP, cyclic citrullinated peptide; DAS28, disease activity score in 28 joints; DMARD, disease-modifying antirheumatic drug; EULAR, European League Against Rheumatism; HAQ, health assessment questionnaire; RF, rheumatoid factor.