Table 2

Association between baseline demographic characteristics, clinical data and laboratory values with methotrexate-related adverse events

Unadjusted OR (95% CI)p ValueAdjusted OR (95%CI)p Value
Age (years)1.001 (0.97 to 1.03)0.9610.997 (0.97 to 1.03)0.842
Gender (female vs male)1.228 (0.49 to 3.07)0.6601.250 (0.49 to 3.17)0.639
BMI (kg/m2)1.074 (0.96 to 1.20)0.1971.076 (0.95 to 1.21)0.236
Swollen joint count (number)0.956 (0.89 to 1.03)0.2500.956 (0.89 to 1.03)0.250
Tender joint count (number)0.991 (0.93 to 1.06)0.7790.986 (0.93 to 1.05)0.677
VAS pain (mm)1.012 (1.00 to 1.03)0.1721.007 (0.99 to 1.03)0.398
VAS general well-being (mm)1.011 (0.99 to 1.03)0.2471.010 (0.99 to 1.03)0.327
Functional disability (HAQ)1.316 (0.66 to 2.62)0.4331.138 (0.54 to 2.38)0.732
ESR (mm/h)0.987 (0.97 to 1.01)0.1910.987 (0.97 to 1.01)0.193
Creatinine (µmol/l)1.013 (0.98 to 1.05)0.4441.008 (0.98 to 1.04)0.644
Creatinine clearance (ml/min)0.999 (0.98 to 1.02)0.9531.002 (0.98 to 1.02)0.872
AST (U/l)0.992 (0.94 to 1.05)0.7650.992 (0.94 to 1.05)0.761
ALT (U/l)1.008 (0.98 to 1.04)0.6070.999 (0.97 to 1.03)0.959
Rheumatoid factor status (positive vs negative)2.263 (0.73 to 6.99)0.1562.464 (0.77 to 7.89)0.129
  • Unadjusted and adjusted odds ratios (OR) (adjusted for treatment arm and NSAID use at baseline).

  • ALT, serum alanine aminotransferase; AST, serum aspartate aminotransferase; BMI, body mass index, ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire (0–3, most functional disability); NSAID, non-steroidal anti-inflammatory drug; VAS, visual analogue scale pain and general wellbeing (range 0–100 mm, worst score).