Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

Figures & data

Figure 1. Observation period.

Table 1. Patient demographics.

	Overall	CD/IBDU	UC
Number	192	105 (55%)	87 (45%)
Age
Mean (SD)	44.6 (16.1)	45.0 (15.5)	44.1 (16.8)
Gender
Female	97 (51%)	63 (60%)	34 (39%)
Male	95 (49%)	42 (40%)	53 (61%)
Ethnicity
Caucasian	171 (89%)	94 (90%)	77 (89%)
Asian	15 (8%)	8 (7.5%)	7 (8%)
Black	1 (0.5%)	1 (1%)	0 (0%)
Other/unknown	5 (2.5%)	2 (2%)	3 (3%)
Smoking status
Current	26 (14%)	23 (22%)	3 (3%)
Never	112 (58%)	50 (48%)	62 (71%)
Ex-smoker	29 (15%)	18 (17%)	11 (13%)
Unknown	25 (13%)	14 (13%)	11 (13%)
Malignancy history
Yes	12 (6%)	8 (8%)	4 (5%)
BMI
Median (IQR)	25.7 (22.5 to 31.4)	25.6 (21.9 to 31.5)	26.1 (23.0–31.3)
Disease extent (Montreal classification)
CD
Age at onset
A1 (<17 years)	21 (11%)	13 (13%)	8 (9%)
A2 (17–40 years)	103 (56%)	58 (58%)	45 (53%)
A3 ( ≥40 years)	61 (33%)	29 (29%)	32 (38%)
Disease behaviour
B1 (non-stricturing, non-penetrating or inflammatory)		50 (48%)
B2 (stricturing)		30 (29%)
B3 (penetrating)		24 (23%)
Disease location
L1 (ileal)		18 (17%)
L2 (colonic)		28 (27%)
L3 (ileocolonic)		50 (48%)
L4 (isolated upper disease)/Upper GI		8 (8%)
Perianal		30 (29%)
UC
E1 (ulcerative proctitis)			3 (3%)
E2 (distal or left sided UC)			52 (59%)
E3 (extensive UC or pancolitis)			33 (38%)
Disease duration (years)
Median		12.3	5.4
IQR		4.9 to 18.0	3.2 to 12.8

Variables presented as number (percentage) or median (IQR).

Table 2. Treatment history.

	Overall (n = 192)	CD/IBDU (n = 105)	UC (n = 87)
Vedolizumab indication^a
Endoscopic or radiological evidence of active disease	39 (20%)	22 (21%)	17 (20%)
Corticosteroid dependency	21 (11%)	2 (2%)	19 (22%)
Intolerance to immunomodulators	21 (11%)	9 (9%)	12 (14%)
Intolerant to TNF inhibitors	23 (12%)	19 (18%)	4 (5%)
Primary non-responders to TNF inhibitors	67 (35%)	35 (33%)	32 (37%)
Loss of response to TNF	21 (11%)	18 (17%)	3 (3%)
Corticosteroids
Y	186 (97%)	101 (96%)	85 (98%)
N	6 (3%)	4 (4%)	2 (2%)
Immunomodulators
Y	180 (94%)	99 (94%)	81 (93%)
N	12 (6%)	6 (6%)	6 (7%)
One immunomodulator	97 (51%)	55 (52%)	42 (48%)
Two immunomodulators	59 (31%)	29 (28%)	30 (34%)
Three immunomodulators	23 (12%)	14 (13%)	9 (10%)
Four immunomodulators	1 (1%)	1 (1%)	0 (0%)
Azathioprine
Y	150 (79%)	80 (76%)	70 (81%)
N	41 (21%)	25 (24%)	16 (19%)
Ciclosporin
Y	19 (10%)	3 (3%)	16 (19%)
N	172 (90%)	102 (97%)	70 (81%)
Mercaptopurine
Y	81 (42%)	44 (42%)	37 (43%)
N	110 (58%)	61 (58%)	49 (57%)
Methotrexate
Y	38 (20%)	32 (30%)	6 (7%)
N	153 (80%)	73 (70%)	80 (93%)
Anti-TNF status
Naive	50 (26%)	10 (10%)	40 (46%)
Experienced	142 (74%)	95 (90%)	47 (54%)
One anti-TNF agent	83 (43%)	47 (45%)	36 (41%)
Two anti-TNF agents	59 (31%)	48 (46%)	11 (13%)
Median (weeks) exposure to vedolizumab
Median (IQR)	32.3 (22.0-54.0)	31.0 (21.3–51.1)	38.4 (23.7–61.1)

^a Some patients had more than one indication for vedolizumab therapy.

Figure 2. Kaplan-Meier plot of time to corticosteroid-free remission.

Figure 3. Kaplan-Meier plot of time to first clinical remission.

Figure 4. Kaplan-Meier plot of time to corticosteroid-free remission according to exposure to anti-TNF therapy for UC cohort only.

Table 3. Rates of remission and response to vedolizumab achieved during observation period.

	CD	UC
Corticosteroid free remission	45%	46%
Clinical remission	44%	52%
Clinical response	53%	49%

Table 4. Distribution of adverse events in patients receiving vedolizumab.

	CD/IBDU (n = 105)	UC (n = 87)	Overall (n = 192)
Total number of AEs	9	3	12
Intolerance	3 (33%)	2 (67%)	5 (42%)
Allergic	1 (11%)	0 (0%)	1 (8%)
Other	5 (56%)	1 (33%)	6 (50%)