Skip to main content

Table 5 Association between patient background and occurrence of infections, PGA response, and reduction in ocular attacks

From: Safety and efficacy of infliximab in the treatment of refractory uveoretinitis in Behçet’s disease: a large-scale, long-term postmarketing surveillance in Japan

 

Infections

PGA response

Reduction in ocular attacks

All

Occurred

p a

Allb

Response ratec

p a

Alld

Absence of ocular attackse

p a

n

n (%)

n

n (%)

n

n (%)

All patients

656

78 (11.89)

623

503 (80.7)

506

217 (42.9)

Disease duration of BD, years

 < 5

268

25 (9.33)

0.130

255

216 (84.7)

0.008

212

88 (41.5)

0.216

 ≥ 5–< 10

159

17 (10.69)

 

153

128 (83.7)

 

129

62 (48.1)

 

 ≥ 10–< 15

95

17 (17.89)

 

88

70 (79.5)

 

73

24 (32.9)

 

 ≥ 15

77

11 (14.29)

 

74

50 (67.6)

 

55

23 (41.8)

 

 unknown

57

8 (14.04)

 

53

39 (73.6)

 

37

20 (54.1)

 

Disease duration of uveitis, years

 < 5

294

28 (9.52)

0.080

274

234 (85.4)

0.030

234

99 (42.3)

0.011

 ≥ 5–< 10

166

19 (11.45)

 

162

132 (81.5)

 

130

70 (53.8)

 

 ≥ 10–< 15

86

17 (19.77)

 

82

66 (80.5)

 

71

22 (31.0)

 

 ≥ 15

60

7 (11.67)

 

58

40 (69.0)

 

41

15 (36.6)

 

 unknown

50

7 (14.00)

 

47

31 (66.0)

 

30

11 (36.7)

 

Severity of ocular symptoms

 severe

408

53 (12.99)

0.342

390

326 (83.6)

< 0.001

332

125 (37.7)

0.007

 moderate

201

18 (8.96)

 

193

157 (81.3)

 

154

81 (52.6)

 

 mild

36

4 (11.11)

 

33

18 (54.5)

 

14

7 (50.0)

 

 unknown

11

3 (27.27)

 

7

2 (28.6)

 

6

4 (66.7)

 

History of allergic disease

 no

618

69 (11.17)

0.034

586

472 (80.5)

0.830

480

206 (42.9)

1.000

 yes

38

9 (23.68)

 

37

31 (83.8)

 

26

11 (42.3)

 

Extraocular symptoms of BD

 oral aphthous ulcersf

  no

117

11 (9.40)

0.432

112

81 (72.3)

0.016

82

34 (41.5)

0.808

  yes

534

66 (12.36)

 

506

419 (82.8)

 

421

182 (43.2)

 

 skin lesionsf

  no

259

30 (11.58)

0.902

245

186 (75.9)

0.012

197

76 (38.6)

0.118

  yes

392

47 (11.99)

 

373

314 (84.2)

 

306

140 (45.8)

 

 central nervous system lesionsf

  no

587

68 (11.58)

0.542

559

463 (82.8)

0.001

460

197 (42.8)

0.873

  yes

64

9 (14.06)

 

59

37 (62.7)

 

43

19 (44.2)

 

 intestinal tract lesionsf

  no

584

67 (11.47)

0.423

557

460 (82.6)

0.003

471

200 (42.5)

0.462

  yes

67

10 (14.93)

 

61

40 (65.6)

 

32

16 (50.0)

 

Comorbidity

 respiratory disease

  no

646

74 (11.46)

0.022

614

497 (80.9)

0.385

500

215 (43.0)

0.704

  yes

10

4 (40.00)

 

9

6 (66.7)

 

6

2 (33.3)

 

 cardiac disease

  no

646

76 (11.76)

0.338

616

500 (81.2)

0.029

499

213 (42.7)

0.469

  yes

10

2 (20.00)

 

7

3 (42.9)

 

7

4 (57.1)

 

 diabetes mellitus

  no

625

74 (11.84)

0.778

593

486 (82.0)

0.002

486

214 (44.0)

0.010

  yes

31

4 (12.90)

 

30

17 (56.7)

 

20

3 (15.0)

 

Concomitant drug

 cyclosporine

  no

443

48 (10.84)

0.247

418

338 (80.9)

0.914

332

158 (47.6)

0.003

  yes

213

30 (14.08)

 

205

165 (80.5)

 

174

59 (33.9)

 

 glucocorticoids

  no

124

10 (8.06)

0.167

114

101 (88.6)

0.018

93

43 (46.2)

0.488

  yes

532

68 (12.78)

 

509

402 (79.0)

 

413

174 (42.1)

 
  1. The association between the safety/efficacy and patient background factors (as described in Table 1) such as sex, age, and comorbidity were evaluated using univariate analysis. Results were shown in the patient background with significant (p < 0.05) association with occurrence of infections, physician global assessment (PGA) response, or reduction in ocular attacks
  2. aStatistical difference was evaluated using chi-square test or Fisher’s exact test, excluding the “unknown” patients
  3. bPatients with available PGA data excluding “underminable”
  4. cResponse was defined as improved or slightly improved
  5. dEvaluated in 506 patients who showed at least one ocular attacks in prior 6 months and had no history of infliximab treatment
  6. ePatients with absence of ocular attacks during the study period
  7. fn = 643 (excluded the 5 patients without data on extraocular symptoms of Behçet’s disease (BD))