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Table 1 Demographic and disease characteristics at index date

From: Effectiveness and safety of vedolizumab induction with or without budesonide in patients with moderately to severely active Crohn’s disease in Europe: a retrospective observational study

Characteristic

VDZ alone

(N = 73)

VDZ + BUD

(N = 50)

Overall population

(N = 123)

P-value

Age, years, median (IQR)

45.0 (32.0, 56.0)

42.0 (30.0, 50.0)

45.0 (30.0, 55.0)

0.5494

Female, n (%)

39 (53.4)

32 (64.0)

71 (57.7)

0.2447

Smoking status, n (%)

0.9971

 Current

23 (31.5)

16 (32.0)

39 (31.7)

 

 Former

12 (16.4)

8 (16.0)

20 (16.3)

 

Duration of CDa, n (%)

0.0961

 < 2 years

9 (12.3)

12 (24.0)

21 (17.1)

 

 ≥ 2 years

64 (87.7)

38 (76.0)

102 (82.9)

 

Physician assessment of disease activity, n (%)

0.6537

 Not evaluated

7 (9.6)

5 (10.0)

12 (9.8)

 

 Moderate

55 (75.3)

36 (72.0)

91 (74.0)

 

 Severe

11 (15.1)

9 (18.0)

20 (16.3)

 

Abdominal painb, n (%)

0.1436

 None

7 (9.6)

1 (2.0)

8 (6.5)

 

 Mild

8 (11.0)

2 (4.0)

10 (8.1)

 

 Moderate

53 (72.6)

40 (80.0)

93 (75.6)

 

 Severe

5 (6.8)

7 (14.0)

12 (9.8)

 

Mean daily number

of loose stoolsb, median (IQR)

5.0 (4.0, 7.0)

5.0 (4.0, 6.5)

5.0 (4.0, 7.0)

0.3948

Fecal calprotectinc, n/N (%)

NA

 ≤ 250 µg/g

2/61 (3.3)

4/34 (11.8)

6/95 (6.3)

 

 > 250 µg/g

18/61 (29.5)

4/34 (11.8)

22/95 (23.2)

 

CRPc, n/N (%)

NA

 < 0.8 mg/L

2/61 (3.3)

5/34 (14.7)

7/95 (7.4)

 

 ≥ 0.8 mg/L

55/61 (90.2)

28/34 (82.4)

83/95 (87.4)

 

Prior treatment for CDd, e, n (%)

 No treatment

1 (1.4)

5 (10.0)

6 (4.9)

 

 Anti-TNF agents

60 (83.3)

40 (88.9)

100 (85.5)

0.7594

 Immunomodulators

55 (76.4)

36 (80.0)

91 (77.8)

0.6781

 Aminosalicylates

26 (36.1)

12 (26.7)

38 (32.5)

0.1708

 Corticosteroids (topical)

46 (63.9)

29 (64.4)

75 (64.1)

0.5756

 Corticosteroids (systemic)

5 (6.9)

5 (11.1)

10 (8.5)

0.5300

Disease location (Montreal classification), n (%)

NA

 L1 ileum

34 (54.8)

21 (47.7)

55 (51.9)

 

 L2 colon

12 (19.4)

6 (13.6)

18 (17.0)

 

 L3 ileocolon

13 (21.0)

15 (34.1)

28 (26.4)

 

 L1 + L4 upper gastrointestinal tract

2 (3.2)

1 (2.3)

3 (2.8)

 

 L2 + L4 upper gastrointestinal tract

0 (0.0)

1 (2.3)

1 (0.9)

 

 L3 + L4 upper gastrointestinal tract

1 (1.6)

0 (0.0)

1 (0.9)

 
  1. aAssessed since CD diagnosis until the index date
  2. bReported by the patient and not evaluated at index date
  3. cOverall, 28 patients were not evaluated for laboratory assessments (including CRP, fecal calprotectin, hemoglobin, and serum albumin) at index date
  4. dAssessed since CD diagnosis until index date; percentages calculated from the number of patients receiving prior treatments for CD. Treatments prescribed were grouped using the following categories: Anti-TNF agents: adalimumab, certolizumab pegol, golimumab, infliximab. Immunomodulators: azathioprine, mercaptopurine, methotrexate. Aminosalicylates: mesalazine, sulfasalazine. Corticosteroids (topical): budesonide (MMX), beclomethasone dipropionate. Corticosteroids (systemic): methylprednisolone, prednisone
  5. eTwo patients in the VDZ + BUD group received prior treatment with other immunosuppressant monoclonal antibodies (natalizumab and ustekinumab)
  6. BUD = budesonide; CD = Crohn’s disease; CRP = C-reactive protein; IQR = interquartile range; NA = not available; TNF = tumor necrosis factor; VDZ = vedolizumab
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BMC Gastroenterology

ISSN: 1471-230X

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