Clinical profiles and outcomes in patients with ulcerative colitis receiving standard and higher-than-standard doses of vedolizumab: findings from a real-world study in Europe

Figures & data

Table 1. Vedolizumab dosing patterns by country.

Variable	Overall	France	Germany	Italy	Spain	UK
	(n = 448)	(n = 92)	(n = 76)	(n = 97)	(n = 98)	(n = 85)
Induction dosing schedule^a, n	429	86	72	97	95	79
300 mg at wk 0, n (%)	9 (2.1)	2 (2.3)	1 (1.4)	4 (4.1)	2 (2.1)	0 (0.0)
300 mg at wk 0, 2, n (%)	18 (4.2)	6 (7.0)	4 (5.6)	1 (1.0)	3 (3.2)	4 (5.1)
300 mg at wk 0, 4, n (%)	9 (2.1)	0 (0.0)	0 (0.0)	0 (0.0)	9 (9.5)	0 (0.0)
300 mg at wk 0, 8, n (%)	1 (0.2)	1 (1.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
300 mg at wk 0, 2, 4, n (%)	19 (4.4)	0 (0.0)	7 (9.7)	6 (6.2)	1 (1.1)	5 (6.3)
300 mg at wk 0, 2, 6, n (%)	332 (77.4)	70 (81.4)	56 (77.8)	74 (76.3)	72 (75.8)	60 (75.9)
300 mg at wk 0, 2, 8, n (%)	23 (5.4)	5 (5.8)	2 (2.8)	7 (7.2)	2 (2.1)	7 (8.9)
300 mg at wk 0, 3, 6, n (%)	2 (0.5)	0 (0.0)	0 (0.0)	1 (1.0)	1 (1.1)	0 (0.0)
300 mg at wk 0, 4, 8, n (%)	2 (0.5)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	2 (2.5)
300 mg at wk 0, 2, 6, 10, n (%)	12 (2.8)	2 (2.3)	1 (1.4)	3 (3.1)	5 (5.3)	1 (1.3)
300 mg at wk 0, 4, 8, 12, 16, n (%)	1 (0.2)	0 (0.0)	0 (0.0)	1 (1.0)	0 (0.0)	0 (0.0)
300 mg at wk 0, 2, 6, 108 mg at wk 8, n (%)	1 (0.2)	0 (0.0)	1 (1.4)	0 (0.0)	0 (0.0)	0 (0.0)
Current maintenance dose, n	448	92	76	97	98	85
Standard dose, n (%)	374 (83.5)	79 (85.9)	62 (81.6)	75 (77.3)	80 (81.6)	78 (91.8)
IV 300 mg Q8/wk, n (%)	268 (59.8)	50 (54.3)	43 (56.6)	69 (71.1)	60 (61.2)	46 (54.1)
SC 108 mg Q2/wk, n (%)	106 (23.7)	29 (31.5)	19 (25.0)	6 (6.2)	20 (20.4)	32 (37.6)
Higher-than-standard dose, n (%)	46 (10.3)	8 (8.7)	3 (3.9)	18 (18.6)	11 (11.2)	6 (7.1)
IV 300 mg Q4/wk, n (%)	24 (5.4)	4 (4.3)	1 (1.3)	10 (10.3)	7 (7.1)	2 (2.4)
IV 300 mg Q5/wk, n (%)	1 (0.2)	0 (0.0)	1 (1.3)	0 (0.0)	0 (0.0)	0 (0.0)
IV 300 mg Q6/wk, n (%)	19 (4.2)	3 (3.3)	1 (1.3)	8 (8.2)	4 (4.1)	3 (3.5)
IV 300 mg Q7/wk, n (%)	1 (0.2)	1 (1.1)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
SC 108 mg Q1/wk, n (%)	1 (0.2)	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.2)
Lower than standard dose, n (%)	28 (6.3)	5 (5.4)	11 (14.5)	4 (4.1)	7 (7.1)	1 (1.2)
IV 300 mg Q12/wk, n (%)	1 (0.2)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.0)	0 (0.0)
SC 108 mg Q4/wk, n (%)	5 (1.1)	2 (2.2)	1 (1.3)	0 (0.0)	2 (2.0)	0 (0.0)
SC 108 mg Q6/wk, n (%)	2 (0.4)	0 (0.0)	0 (0.0)	0 (0.0)	2 (2.0)	0 (0.0)
SC 108 mg Q8/wk, n (%)	19 (4.2)	3 (3.3)	9 (11.8)	4 (4.1)	2 (2.0)	1 (1.2)
SC 108 mg Q9/ wk, n (%)	1 (0.2)	0 (0.0)	1 (1.3)	0 (0.0)	0 (0.0)	0 (0.0)
Current maintenance dose frequency (IV), n	314	58	46	87	72	51
Mean time between doses in weeks, mean ± SD	7.6 ± 1.2	7.6 ± 1.1	7.8 ± 0.8	7.4 ± 1.4	7.6 ± 1.4	7.7 ± 0.9
Current maintenance dose frequency (SC), n	134	34	30	10	26	34
Mean time between doses in weeks, mean ± SD	3.0 ± 2.2	2.7 ± 1.8	4.1 ± 2.9	4.4 ± 3.1	2.9 ± 1.9	2.2 ± 1.1
Current maintenance dose duration^a, weeks, n	412	87	66	95	88	76
Mean ± SD	59.7 ± 72.4	51.0 ± 62.5	42.9 ± 50.5	61.2 ± 81.1	85.0 ± 87.1	53.0 ± 62.2
Median (IQR)	37.0	34.6	29.4	31.9	49.3	33.1
	(15.6–66.5)	(13.0–55.4)	(13.9–46.4)	(8.9–72.9)	(31.6–105.3)	(14.1–58.6)
Time since start of maintenance phase^a, weeks, n	411	86	66	97	88	74
Mean ± SD	66.1 ± 76.3	61.3 ± 71.3	43.5 ± 50.2	65.4 ± 84.6	89.7 ± 86.5	64.7 ± 71.2
Median (IQR)	40.0	39.2	30.8	36.6	50.2	38.0
	(19.3–77.3)	(18.3–67.3)	(15.0–46.4)	(10.4–74.3)	(36.4–113.6)	(19.0–97.9)
Change in dose/frequency/route of administration since start of maintenance phase^a, n	441	89	76	96	97	83
No change, n (%)	398 (90.2)	78 (87.6)	73 (96.1)	89 (92.7)	87 (89.7)	71 (85.5)
Dose/frequency increased, n (%)	14 (3.2)	4 (4.5)	1 (1.3)	3 (3.1)	4 (4.1)	2 (2.4)
Dose/frequency decreased, n (%)	2 (0.5)	1 (1.1)	0 (0.0)	0 (0.0)	1 (1.0)	0 (0.0)
Dose/frequency varied up and down, n (%)	4 (0.9)	2 (2.2)	0 (0.0)	1 (1.0)	0 (0.0)	1 (1.2)
Route of administration change (IV -> SC), n (%)	21 (4.8)	4 (4.5)	2 (2.6)	1 (1.0)	5 (5.2)	9 (10.8)
Route of administration change (SC -> IV), n (%)	2 (0.5)	0 (0.0)	0 (0.0)	2 (2.1)	0 (0.0)	0 (0.0)

Abbreviations. IQR, interquartile range; IV, intravenous; SC, subcutaneous; SD, standard deviation; wk, week.

^aPatients with known data.

Table 2. Physician reason for current vedolizumab dose choice.

Variable	Overall	Standard dose	Higher-than-standard dose
Reason for current dose choice^a, n	420	374	46
Worsening of symptoms, n (%)	57 (13.6)	43 (11.5)	14 (30.4)
Improvement of symptoms, n (%)	138 (32.9)	138 (36.9)	n/a
No improvement in symptoms, n (%)	16 (3.8)	7 (1.9)	9 (19.6)
Worsening of mucosa, n (%)	12 (2.9)	9 (2.4)	3 (6.5)
Improvement in mucosa, n (%)	47 (11.2)	47 (12.6)	n/a
No improvement in mucosa, n (%)	7 (1.7)	5 (1.3)	2 (4.3)
Remission achieved, n (%)	129 (30.7)	129 (34.5)	n/a
To control patient’s flares, n (%)	113 (26.9)	105 (28.1)	8 (17.4)
Safety/side effects, n (%)	50 (11.9)	50 (13.4)	n/a
Bio-experienced/ difficult-to-treat, n (%)	21 (5.0)	18 (4.8)	3 (6.5)
Poor adherence, n (%)	5 (1.2)	5 (1.3)	n/a
Local protocol/guideline/formulary/insurance coverage, n (%)	72 (17.1)	63 (16.8)	9 (19.6)
Patient’s request, n (%)	22 (5.2)	20 (5.3)	2 (4.3)
Other	13 (3.1)	11 (2.9)	2 (4.3)

Abbreviation. n/a, not applicable.

^aPhysicians could provide multiple responses.

Table 3. Patient demographics and clinical characteristics.

Variable	Overall	Standard dose	Higher-than-standard dose
Total patient number, n (%)	420	374	46
Age, years, mean ± SD	45.0 ± 15.0	44.5 ± 14.7	48.7 ± 16.4
Sex, n
Male, n (%)	227 (54.1)	203 (54.3)	24 (52.2)
Female, n (%)	192 (45.7)	170 (45.5)	22 (47.8)
Intersex, n (%)	1 (0.2)	1 (0.3)	0 (0.0)
BMI, kg/m^2, mean ± SD	24.1 ± 3.2	24.1 ± 3.0	24.1 ± 4.4
Ethnic origin^a, n	333	295	38
White, n (%)	308 (92.5)	272 (92.2)	36 (94.7)
Employment status^b, n	384	341	43
Working full time, n (%)	241 (62.8)	217 (63.6)	24 (55.8)
Time since diagnosis^b, years, n	386	345	41
Mean ± SD	5.9 ± 5.8	5.9 ± 5.9	5.6 ± 4.5
Median (IQR)	3.9	3.9	4.0
	(1.9-7.7)	(1.9-7.7)	(2.2-8.3)
Time since start of maintenance phase^b, weeks, n	383	338	45
Mean ± SD	69.0 ± 78.1	67.6 ± 75.0	79.2 ± 98.6
Median (IQR)	41.4	41.9	38.0
	(20.4-85.0)	(21.6-80.9)	(16.7-112.3)
Current maintenance dose duration^b, weeks, n	384	341	43
Mean ± SD	62.1 ± 74.2	61.6 ± 70.6	66.0 ± 99.4
Median (IQR)	37.9	39.7	22.4
	(16.9–71.9)	(18.3–72.3)	(6.6–62.9)
Concomitant conditions (top 5), n	420	374	46
Anxiety, n (%)	68 (16.2)	53 (14.2)	15 (32.6)
Anaemia, n (%)	47 (11.2)	30 (8.0)	17 (37.0)
Depression, n (%)	33 (7.9)	28 (7.5)	5 (10.9)
Diabetes without chronic complications, n (%)	22 (5.2)	21 (5.6)	1 (2.2)
Metabolic syndrome, n (%)	21 (5.0)	20 (5.3)	1 (2.2)
Current disease activity (Mayo score), n	420	374	46
Remission, n (%)	280 (66.7)	264 (70.6)	16 (34.8)
Mild, n (%)	76 (18.1)	59 (15.8)	17 (37.0)
Moderate, n (%)	61 (14.5)	49 (13.1)	12 (26.1)
Severe, n (%)	3 (0.7)	2 (0.5)	1 (2.2)
Current symptoms (top six)^b, n	419	373	46
Fatigue/tiredness	120 (28.6)	103 (27.6)	17 (37.0)
Abdominal pain	77 (18.4)	66 (17.7)	11 (23.9)
Diarrhoea – non bloody	68 (16.2)	58 (15.5)	10 (21.7)
Abdominal distension	66 (15.8)	58 (15.5)	8 (17.4)
Flatulence	59 (14.1)	54 (14.5)	5 (10.9)
`Bowel urgency	52 (12.4)	43 (11.5)	9 (19.6)
Current remission status
Clinical remission achieved?^c, n	416	370	46
Yes, n (%)	362 (87.0)	331 (89.5)	31 (67.4)
Time in clinical remission^b, months, n	320	292	28
Mean ± SD	17.4 ± 21.4	17.1 ± 20.1	20.3 ± 32.7
Median (IQR)	10.4	10.7	9.1
	(4.8–21.8)	(4.9–21.8)	(2.6–18.1)
Endoscopic remission achieved?^d, n	299	262	37
Yes, n (%)	214 (71.6)	200 (76.3)	14 (37.8)
Time in endoscopic remission^b, n	181	168	13
Mean ± SD	17.5 ± 22.6	16.5 ± 20.7	30.3 ± 38.8
Median (IQR)	10.9	10.8	12.6
	(4.2–19.7)	(4.3–19.3)	(3.9–36.9)
Corticosteroid use
Receiving currently?, n	420	374	46
Yes, n (%)	21 (5.0)	16 (4.3)	5 (10.9)
Received during the current vedolizumab treatment?^b, n	342	304	38
Yes, n (%)	176 (51.5)	155 (51.0)	21 (55.3)
Ever received since diagnosis?^b, n	389	346	43
Yes, n (%)	356 (91.5)	315 (91.0)	41 (95.4)
Immunomodulator use
Receiving currently?, n	420	374	46
Yes, n (%)	41 (9.8)	35 (9.4)	6 (13.0)
Number of previous advanced therapies^e, n (%)	420	374	46
0	244 (58.1)	219 (58.6)	25 (54.3)
1	137 (32.6)	123 (32.9)	14 (30.4)
2+	39 (9.3)	32 (8.6)	7 (15.2)
Number of HCP consultations in the last 12 months, n	420	374	46
Mean ± SD	6.6 ± 4.9	6.4 ± 4.8	7.9 ± 5.8
Number of tests in the last 12 months, total, mean ± SD	34.6 ± 21.5	33.4 ± 19.7	44.0 ± 31.2
Biopsies, mean ± SD	0.8 ± 0.7	0.8 ± 0.7	0.6 ± 0.8
Endoscopies, mean ± SD	1.3 ± 1.6	1.3 ± 1.6	1.4 ± 1.1
Imaging tests, mean ± SD	0.8 ± 1.4	0.9 ± 1.4	0.7 ± 1.0
Stool tests, mean ± SD	2.5 ± 1.7	2.5 ± 1.7	2.7 ± 1.7
Blood tests, mean ± SD	26.1 ± 18.5	25.1 ± 16.8	34.3 ± 28.1
Number of hospitalizations in the last 12 months^b, n	404	360	44
Mean ± SD	0.2 ± 0.5	0.1 ± 0.5	0.3 ± 0.7
Median (IQR)	0 (0.0–0.0)	0 (0.0–0.0)	0 (0.0–0.0)

Abbreviations. IQR, interquartile range; SD, standard deviation; HCP, healthcare professional.

^aData presented for Germany, Italy, Spain, and United Kingdom; ethnic origin data not collected in France due to legal restrictions.

^bPatients with known data.

^cClinical remission: reduction or absence of symptoms.

^dEndoscopic remission: absence of inflammation confirmed by biopsy/scoping (e.g. no erosions or ulcers).

^eAdvanced therapies: biologics, biosimilars, Janus kinase inhibitors.

Table 4. Physician satisfaction with current treatment regime.

Variable	Overall	Standard dose	Higher-than-standard dose
Physician satisfaction with current treatment, n	420	374	46
Satisfied and I believe this is the best control that can be achieved, n (%)	305 (72.6)	285 (76.2)	20 (43.5)
Satisfied, but I believe better control can be achieved, n (%)	93 (22.1)	79 (21.1)	14 (30.4)
Not satisfied, but I believe this is the best control that can be achieved, n (%)	5 (1.2)	1 (0.3)	4 (8.7)
Not satisfied and I believe better control can be achieved, n (%)	17 (4.0)	9 (2.4)	8 (17.4)

Data availability statement

All data, i.e. methodology, materials, data, and data analysis, that support the findings of this survey are the intellectual property of Adelphi Real World. All requests for access should be addressed directly to Hannah Knight at [email protected]. Hannah Knight is an employee of Adelphi Real World.