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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