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Table 2 Factors Affecting Relapse

From: Real life results in using 5-ASA for maintaining mild to moderate UC patients in Japan, a multi-center study, OPTIMUM Study

  Univariate analysis Multivariate analysis#1
No. of patients Hazard ratio Confidence interval of hazard ratio P-value for Wald test statistics Hazard ratio Confidence interval of hazard ratio P-value for Wald test statistics
Age (years) <20 4       
20–30 538 0.778 0.109–5.563 p = 0.8028    
31–40 1063 0.611 0.086–4.358 p = 0.6233    
41–50 1114 0.545 0.076–3.887 p = 0.5450    
51–60 869 0.491 0.069–3.504 p = 0.4777    
61–70 713 0.414 0.058–2.966 p = 0.3802    
≥71 373 0.336 0.046–2.435 p = 0.2807    
Sex Male 2610       
Female 2065 1.165 1.024–1.326 p = 0.0201 1.126 0.988–1.282 p = 0.0744
BMI <18.5 485       
18.5–<25.0 3354 0.883 0.718–1.087 p = 0.2411    
≥25.0 801 0.837 0.653–1.074 p = 0.1630    
Duration of disease (months) <12 344       
12–<60 1424 0.808 0.631–1.034 p = 0.0900    
60–<120 1238 0.738 0.573–0.950 p = 0.0186    
≥120 1652 0.692 0.541–0.885 p = 0.0034    
Classification by the extent of lesion Total colitistype 1942       
Left-sided colitis type 1591 1.204 1.042–1.393 p = 0.0121 1.159 1.001–1.341 p = 0.0487
Proctitis type 1043 0.910 0.762–1.086 p = 0.2937 0.957 0.800–1.144 p = 0.6271
Other 99 0.773 0.461–1.295 p = 0.3282 0.858 0.512–1.439 p = 0.5618
Classification by linical course First onset type 838       
Relapse-remitting type 3427 1.608 1.325–1.952 p < 0.0001 1.456 1.198–1.770 p = 0.0002
Chronic continuous type 410 1.379 1.024–1.859 p = 0.0344 1.133 0.837–1.534 p = 0.4175
Smoking habit Yes 1222       
No 3442 1.036 0.893–1.201 p = 0.6421    
Drinking habit No 2631       
≤1 day/week 992 1.060 0.900–1.247 p = 0.4865    
2–5 days/week 595 1.058 0.867–1.289 p = 0.5797    
≥6 days/week 443 1.050 0.842–1.309 p = 0.6670    
Complications Yes 965       
No 3712 1.094 0.930–1.286 p = 0.2788    
Employment status Student 108       
Part-time worker 534 0.751 0.497–1.135 p = 0.1740    
Full-time worker 2632 0.705 0.482–1.031 p = 0.0714    
Other 1401 0.626 0.424–0.925 p = 0.0186    
Concomitant use of infliximab/adalimumab Yes 129       
No 4548 1.319 0.847–2.054 p = 0.2205    
Concomitant use of tacrolimus Yes 26       
No 4651 0.722 0.300–1.738 p = 0.4674    
Concomitant use of immunomodulator Yes 602       
No 4075 0.874 0.727–1.051 p = 0.1517    
Concomitant use of probiotics Yes 789       
No 3888 0.919 0.777–1.086 p = 0.3208    
Concomitant use of 5-ASA enema/suppository Yes 594       
No 4083 0.757 0.631–0.909 p = 0.0028    
Drug adherence at enrollment <80% 705       
≥80% 3941 1.132 0.939–1.364 p = 0.1926    
Type of oral 5-ASA products at enrollment Pentasa® Tablets 2528       
Asacol® Tablets 1744 1.301 1.136–1.490 p = 0.0001    
Salazopyrin® Tablets 368 1.273 1.007–1.608 p = 0.0435    
Other (generic) 16 0.000 0.000 > 999.999 p = 0.9351    
Concomitant use (oral products) 22 1.092 0.408–2.921 p = 0.8615    
Daily dose of oral 5-ASA products at enrollment (mg) <1500 287       
≥1500–<2500 1982 1.190 0.864–1.640 p = 0.2874    
≥2500 2408 1.780 1.301–2.436 p = 0.0003    
Duration of remission maintenance prior to enrollment#2 (months) <3 1074       
≥3–<12 1013 0.854 0.721–1.011 p = 0.0662 0.928 0.772–1.115 p = 0.4236
≥12–<24 824 0.542 0.445–0.661 p < 0.0001 0.600 0.486–0.740 p < 0.0001
≥24 1703 0.316 0.263–0.380 p < 0.0001 0.352 0.289–0.431 p < 0.0001
Stool frequency score at enrollment 0 3539       
1 874 1.331 1.132–1.564 p = 0.0005 1.129 0.952–1.339 p = 0.1642
2 195 1.788 1.351–2.366 p < 0.0001 1.334 0.986–1.806 p = 0.0618
3 69 0.882 0.439–1.772 p = 0.7243 0.618 0.303–1.262 p = 0.1864
Bloody stool score at enrollment 0 4159       
1 413 1.693 1.371–2.090 p < 0.0001 1.249 0.988–1.578 p = 0.0631
2 98 2.712 1.845–3.987 p < 0.0001 1.721 1.126–2.628 p = 0.0120
3 7 0.000 0.000–>999.999 p = 0.9476 0.000 0.000–>999.999 p = 0.9446
PGA score at enrollment 0 3830       
1 770 1.564 1.324–1.847 p < 0.0001    
2 76 1.212 0.668–2.200 p = 0.5275    
3 1 0.001 0.000–>999.999 p = 0.9535    
  1. #1 Factors affecting relapse in terms of the duration until relapse were investigated using a Cox regression model (multivariate) with the items having p < 0.05 in univariate analysis as explanatory variables
  2. #2 Duration of remission maintenance was counted as 0 month for the patients in active stage at enrollment