Pulusu SSR, Srinivasan A, Krishnaprasad K, Cheng D, Begun J, Keung C, Van Langenberg D, Thin L, Mogilevski T, De Cruz P, Radford-Smith G, Flanagan E, Bell S, Kashkooli S, Sparrow M, Ghaly S, Bampton P, Sawyer E, Connor S, Rizvi QUA, Andrews JM, Mahy G, Chivers P, Travis S, Lawrance IC. Vedolizumab for ulcerative colitis: Real world outcomes from a multicenter observational cohort of Australia and Oxford. World J Gastroenterol 2020; 26(30): 4428-4441 [PMID: 32874055 DOI: 10.3748/wjg.v26.i30.4428]
Corresponding Author of This Article
Ian Craig Lawrance, FRCP (Hon), MBBS, PhD, Professor, Centre for Inflammatory Bowel Diseases, St John of God Hospital, 25 McCourt Street, Subiaco 6008, Western Australia, Australia. ian.lawrance@uwa.edu.au
Research Domain of This Article
Gastroenterology & Hepatology
Article-Type of This Article
Retrospective Cohort Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastroenterol. Aug 14, 2020; 26(30): 4428-4441 Published online Aug 14, 2020. doi: 10.3748/wjg.v26.i30.4428
Table 1 Clinical characteristics of study population
Characteristic
Total (n = 303)
Australia (n = 210)
Oxford (n = 93)
Gender
Female, n (%)
143 (47)
95 (45)
48 (52)
Median age VDZ given (range, yr)
35 (16-84)
36 (19-78)
35 (16-84)
Median disease duration (range, yr)
6 (0.2-48)
7 (1-48)
5.4 (0.2-39.2)
Montreal classification, n (%)
Age
A1
34 (11)
33 (16)
1 (1)
A2
170 (56)
120 (57)
50 (54)
A3
99 (33)
57 (27)
42 (45)
Location
E1
18 (6)
15 (7)
3 (3)
E2
114 (38)
72 (34)
42 (45)
E3
170 (56)
122 (58)
48 (52)
Missing
1
1
0
Family History, n (%)
29 (12)
22 (15)
7 (7)
First degree
19
12
7
Second degree
10
10
0
None
212
126
86
Smoking, n
Never
226
140
86
Current
9
6
3
Ex smoker
45
41
4
Anti-TNF naïve, n (%)
182 (60)
122 (58.1)
60 (65)
Anti-TNF exposed, n (%)
121 (40)
88 (41.9)
33 (35)
Primary LOR
45 (15)
29 (13.8)
16 (17)
Secondary LOR
61 (20)
47 (22.4)
14 (15)
Side-effects
15 (5)
12 (5.7)
3 (3.2)
Steroids at VDZ initiation, n (%)
191 (63)
134 (64)
57 (61.2)
Prednisone
162 (53)
108 (51)
54 (58)
Budesonide
29 (10)
26 (12)
3 (3)
Immunomodulation at VDZ initiation, n (%)
175 (58)
135 (64)
40 (43)
AZA/6MP
136 (45)
108 (51)
28 (30)
Methotrexate
19 (6)
11 (5)
8 (9)
Tacrolimus
17 (6)
16 (8)
1 (1)
Others (Cyclo&Myco)
3 (1)
0
3 (3)
Mean Partial Mayo before VDZ initiation
5 (2-9)
6 (2-9)
5 (2-9)
Table 2 Response and remission at 3 mo of vedolizumab therapy
Total
Australia
Oxford
P value
Response, n (%)
208 (79)
157 (83)
51 (70)
0.01
Remission, n (%)
148 (56)
104 (55)
44 (59)
0.58
Total
Anti-TNF naive
Anti-TNF exposed
P value
Response, n (%)
208 (79)
138 (83)
70 (72)
0.03
Remission, n (%)
148 (56)
109 (66)
39 (40)
< 0.001
Anti-TNF exposed
Primary LOR
Secondary LOR
P value
Response, n (%)
70 (72)
30 (73)
40 (71)
0.85
Remission, n (%)
39 (40)
16 (39)
23 (41)
0.83
Table 3 Remission at 6 mo and 12 mo of vedolizumab therapy
Total
Australia
Oxford
P value
Remission at 6 mo, n (%)
147 (62)
110/173(64)
37/65 (57)
0.34
Remission at 12 mo, n (%)
120/201 (60)
87/138 (63)
33/65 (52)
0.09
Total
Anti-TNF naive
Anti-TNF exposed
Remission at 6 mo, n (%)
147/238 (62)
103/142 (73)
44/96 (46)
< 0.001
Remission at 12 mo, n (%)
120/201 (60)
76/115 (66)
44/86 (51)
0.03
Anti-TNF exposed
Primary LOR
Secondary LOR
Remission at 6 mo, n (%)
44/96 (46)
16/42 (38)
28/54 (52)
0.18
Remission at 12 mo, n (%)
44/86 (51)
17/38 (44)
27/48 (56)
0.28
Table 4 Complications of vedolizumab therapy
Complication
Australia (n = 20)
Oxford (n = 5)
Respiratory infections
URTI (2)
Pneumonia (1)
Sinusitis (4)
Pharyngitis (1)
Nasopharyngitis (1)
Gastrointestinal Infections
Strongyloidis (1)
Gastroenteritis (1)
Clostridium difficile (4)
Buttock abscess (1)
Campylobacter (1)
Oral Thrush (1)
Salmonella (1)
Serious infections
Haemophagocytic syndrome due to CMV (1)
NA
Klebsiella (1)
Others
Rash (1)
NA
Delayed hypersensitivity reaction (1)
Arthralgia and Headaches (1)
Table 5 Colectomy at 12 mo of vedolizumab therapy
Colectomy, n
Australia
Oxford
P value
19/210
13/93
0.25
Colectomy, n
Anti-TNF naive
Anti-TNF exposed
P value
9/182
23/121
0.0005
Colectomy, n
Primary LOS
Secondary LOS
P value
10/45
23/61
0.795
Citation: Pulusu SSR, Srinivasan A, Krishnaprasad K, Cheng D, Begun J, Keung C, Van Langenberg D, Thin L, Mogilevski T, De Cruz P, Radford-Smith G, Flanagan E, Bell S, Kashkooli S, Sparrow M, Ghaly S, Bampton P, Sawyer E, Connor S, Rizvi QUA, Andrews JM, Mahy G, Chivers P, Travis S, Lawrance IC. Vedolizumab for ulcerative colitis: Real world outcomes from a multicenter observational cohort of Australia and Oxford. World J Gastroenterol 2020; 26(30): 4428-4441