Table 3. Open in new tab...

Gastrointestinal symptom	VDZ use vs non-use					VDZ monotherapy vs anti-TNF monotherapy
Overall
Abdominal pain	37	8.1%	250	7.8%	0.847	30	9.0%	58	5.6%	0.026
Diarrhoea	89	19.5%	616	19.3%	0.934	74	22.2%	167	16.0%	0.010
Nausea	32	7.0%	167	5.2%	0.120	29	8.7%	38	3.6%	<0.001
Vomiting	14	3.1%	86	2.7%	0.653	12	3.6%	18	1.7%	0.042
Other	10	2.2%	88	2.8%	0.481	9	2.7%	19	1.8%	0.325
Any GI symptom	116	25.4%	770	24.1%	0.822	99	29.6%	200	19.2%	<0.001
Among patients with active IBD^a
Abdominal pain	18	8.7%	148	11.3%	0.258	13	10.0%	35	10.6%	0.840
Diarrhoea	41	19.8%	289	22.1%	0.449	30	23.1%	80	24.3%	0.779
Nausea	12	5.8%	84	6.4%	0.726	10	7.7%	15	4.6%	0.183
Vomiting	6	2.9%	43	3.3%	0.765	5	3.8%	8	2.4%	0.532
Other	4	1.9%	41	3.1%	0.341	3	2.3%	11	3.3%	0.766
Any GI symptom	49	23.7%	353	27.0%	0.556	37	28.5%	95	28.9%	0.875
Among patients with IBD in remission^a
Abdominal pain	18	7.9%	93	5.3%	0.109	17	9.0%	23	3.4%	0.001
Diarrhoea	46	20.2%	292	16.6%	0.183	43	22.9%	82	12.3%	<0.001
Nausea	20	8.8%	77	4.4%	0.004	19	10.1%	23	3.4%	<0.001
Vomiting	8	3.5%	38	2.2%	0.205	7	3.7%	10	1.5%	0.072
Other	5	2.2%	39	2.2%	0.977	5	2.7%	7	1.0%	0.150
Any GI symptom	64	28.1%	374	21.3%	0.027	60	31.9%	99	14.8%	<0.001

Gastrointestinal symptom

VDZ use vs non-use

VDZ monotherapy vs anti-TNF monotherapy

VDZ

All other IBD therapies

p value

Vedolizumab monotherapy

Anti-TNF monotherapy

p value

[%]

Overall

Abdominal pain

8.1%

250

7.8%

0.847

9.0%

5.6%

0.026

Diarrhoea

19.5%

616

19.3%

0.934

22.2%

167

16.0%

0.010

Nausea

7.0%

167

5.2%

0.120

8.7%

3.6%

<0.001

Vomiting

3.1%

2.7%

0.653

3.6%

1.7%

0.042

Other

2.2%

2.8%

0.481

2.7%

1.8%

0.325

Any GI symptom

116

25.4%

770

24.1%

0.822

29.6%

200

19.2%

<0.001

Among patients with active IBD^a

Abdominal pain

8.7%

148

11.3%

0.258

10.0%

10.6%

0.840

Diarrhoea

19.8%

289

22.1%

0.449

23.1%

24.3%

0.779

Nausea

5.8%

6.4%

0.726

7.7%

4.6%

0.183

Vomiting

2.9%

3.3%

0.765

3.8%

2.4%

0.532

Other

1.9%

3.1%

0.341

2.3%

3.3%

0.766

Any GI symptom

23.7%

353

27.0%

0.556

28.5%

28.9%

0.875

Among patients with IBD in remission^a

Abdominal pain

7.9%

5.3%

0.109

9.0%

3.4%

0.001

Diarrhoea

20.2%

292

16.6%

0.183

22.9%

12.3%

<0.001

Nausea

8.8%

4.4%

0.004

10.1%

3.4%

<0.001

Vomiting

3.5%

2.2%

0.205

3.7%

1.5%

0.072

Other

2.2%

0.977

2.7%

1.0%

0.150

Any GI symptom

28.1%

374

21.3%

0.027

31.9%

14.8%

<0.001

Gastrointestinal symptom	VDZ use vs non-use					VDZ monotherapy vs anti-TNF monotherapy
Overall
Abdominal pain	37	8.1%	250	7.8%	0.847	30	9.0%	58	5.6%	0.026
Diarrhoea	89	19.5%	616	19.3%	0.934	74	22.2%	167	16.0%	0.010
Nausea	32	7.0%	167	5.2%	0.120	29	8.7%	38	3.6%	<0.001
Vomiting	14	3.1%	86	2.7%	0.653	12	3.6%	18	1.7%	0.042
Other	10	2.2%	88	2.8%	0.481	9	2.7%	19	1.8%	0.325
Any GI symptom	116	25.4%	770	24.1%	0.822	99	29.6%	200	19.2%	<0.001
Among patients with active IBD^a
Abdominal pain	18	8.7%	148	11.3%	0.258	13	10.0%	35	10.6%	0.840
Diarrhoea	41	19.8%	289	22.1%	0.449	30	23.1%	80	24.3%	0.779
Nausea	12	5.8%	84	6.4%	0.726	10	7.7%	15	4.6%	0.183
Vomiting	6	2.9%	43	3.3%	0.765	5	3.8%	8	2.4%	0.532
Other	4	1.9%	41	3.1%	0.341	3	2.3%	11	3.3%	0.766
Any GI symptom	49	23.7%	353	27.0%	0.556	37	28.5%	95	28.9%	0.875
Among patients with IBD in remission^a
Abdominal pain	18	7.9%	93	5.3%	0.109	17	9.0%	23	3.4%	0.001
Diarrhoea	46	20.2%	292	16.6%	0.183	43	22.9%	82	12.3%	<0.001
Nausea	20	8.8%	77	4.4%	0.004	19	10.1%	23	3.4%	<0.001
Vomiting	8	3.5%	38	2.2%	0.205	7	3.7%	10	1.5%	0.072
Other	5	2.2%	39	2.2%	0.977	5	2.7%	7	1.0%	0.150
Any GI symptom	64	28.1%	374	21.3%	0.027	60	31.9%	99	14.8%	<0.001

Table 3.

Open in new tab

Gastrointestinal symptoms due to COVID-19 in adult patients on VDZ compared to those on other IBD therapies, and on VDZ monotherapy compared to anti-TNF monotherapy, in the SECURE-IBD registry, overall and stratified by IBD activity

Gastrointestinal symptom	VDZ use vs non-use					VDZ monotherapy vs anti-TNF monotherapy
	VDZ		All other IBD therapies		p value	Vedolizumab monotherapy		Anti-TNF monotherapy		p value
	N	[%]	N	[%]		N	[%]	N	[%]
Overall
Abdominal pain	37	8.1%	250	7.8%	0.847	30	9.0%	58	5.6%	0.026
Diarrhoea	89	19.5%	616	19.3%	0.934	74	22.2%	167	16.0%	0.010
Nausea	32	7.0%	167	5.2%	0.120	29	8.7%	38	3.6%	<0.001
Vomiting	14	3.1%	86	2.7%	0.653	12	3.6%	18	1.7%	0.042
Other	10	2.2%	88	2.8%	0.481	9	2.7%	19	1.8%	0.325
Any GI symptom	116	25.4%	770	24.1%	0.822	99	29.6%	200	19.2%	<0.001
Among patients with active IBD^a
Abdominal pain	18	8.7%	148	11.3%	0.258	13	10.0%	35	10.6%	0.840
Diarrhoea	41	19.8%	289	22.1%	0.449	30	23.1%	80	24.3%	0.779
Nausea	12	5.8%	84	6.4%	0.726	10	7.7%	15	4.6%	0.183
Vomiting	6	2.9%	43	3.3%	0.765	5	3.8%	8	2.4%	0.532
Other	4	1.9%	41	3.1%	0.341	3	2.3%	11	3.3%	0.766
Any GI symptom	49	23.7%	353	27.0%	0.556	37	28.5%	95	28.9%	0.875
Among patients with IBD in remission^a
Abdominal pain	18	7.9%	93	5.3%	0.109	17	9.0%	23	3.4%	0.001
Diarrhoea	46	20.2%	292	16.6%	0.183	43	22.9%	82	12.3%	<0.001
Nausea	20	8.8%	77	4.4%	0.004	19	10.1%	23	3.4%	<0.001
Vomiting	8	3.5%	38	2.2%	0.205	7	3.7%	10	1.5%	0.072
Other	5	2.2%	39	2.2%	0.977	5	2.7%	7	1.0%	0.150
Any GI symptom	64	28.1%	374	21.3%	0.027	60	31.9%	99	14.8%	<0.001

Gastrointestinal symptom	VDZ use vs non-use					VDZ monotherapy vs anti-TNF monotherapy
	VDZ		All other IBD therapies		p value	Vedolizumab monotherapy		Anti-TNF monotherapy		p value
	N	[%]	N	[%]		N	[%]	N	[%]
Overall
Abdominal pain	37	8.1%	250	7.8%	0.847	30	9.0%	58	5.6%	0.026
Diarrhoea	89	19.5%	616	19.3%	0.934	74	22.2%	167	16.0%	0.010
Nausea	32	7.0%	167	5.2%	0.120	29	8.7%	38	3.6%	<0.001
Vomiting	14	3.1%	86	2.7%	0.653	12	3.6%	18	1.7%	0.042
Other	10	2.2%	88	2.8%	0.481	9	2.7%	19	1.8%	0.325
Any GI symptom	116	25.4%	770	24.1%	0.822	99	29.6%	200	19.2%	<0.001
Among patients with active IBD^a
Abdominal pain	18	8.7%	148	11.3%	0.258	13	10.0%	35	10.6%	0.840
Diarrhoea	41	19.8%	289	22.1%	0.449	30	23.1%	80	24.3%	0.779
Nausea	12	5.8%	84	6.4%	0.726	10	7.7%	15	4.6%	0.183
Vomiting	6	2.9%	43	3.3%	0.765	5	3.8%	8	2.4%	0.532
Other	4	1.9%	41	3.1%	0.341	3	2.3%	11	3.3%	0.766
Any GI symptom	49	23.7%	353	27.0%	0.556	37	28.5%	95	28.9%	0.875
Among patients with IBD in remission^a
Abdominal pain	18	7.9%	93	5.3%	0.109	17	9.0%	23	3.4%	0.001
Diarrhoea	46	20.2%	292	16.6%	0.183	43	22.9%	82	12.3%	<0.001
Nausea	20	8.8%	77	4.4%	0.004	19	10.1%	23	3.4%	<0.001
Vomiting	8	3.5%	38	2.2%	0.205	7	3.7%	10	1.5%	0.072
Other	5	2.2%	39	2.2%	0.977	5	2.7%	7	1.0%	0.150
Any GI symptom	64	28.1%	374	21.3%	0.027	60	31.9%	99	14.8%	<0.001

Abbreviations: COVID-19 = coronavirus disease 2019; SECURE-IBD = Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease; VDZ = vedolizumab; TNF = tumor necrosis factor.

Statistically significant associations are in bold.

^aBased on Physician Global Assessment [PGA].

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