Gastroenterol Res

Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access

Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc

Journal website https://www.gastrores.org

Original Article

Volume 14, Number 6, December 2021, pages 324-333

Corticosteroid and Biologic Use Not Associated With Adverse Outcomes for Inflammatory Bowel Disease Patients Hospitalized With COVID-19

Figure 1. Flowchart of IBD with COVID-19 patient identification. IBD: inflammatory bowel disease; COVID-19: coronavirus disease 2019.

**Table 1.** Demographics, Clinical Characteristics, and IBD Medications of All IBD/COVID-19 Patients and Patients Separated Into ED Visit Only and Hospitalized (n = 83)
	All IBD/COVID-19 (n = 83)	IBD/COVID-19 patients with ED visit only (n = 27)	IBD/COVID-19 patients hospitalized (n = 56)
^aCalculated from first weight recorded in 2020. ^bExcluding non-melanoma skin cancer. ^cIncludes one colon cancer with brain metastases disease. AIDS: acquired immunodeficiency syndrome; BMI: body mass index; CAD: coronary artery disease; CD: Crohn’s disease; COVID-19: coronavirus disease 2019; DVT: deep vein thrombosis; ED: emergency department; HCV: hepatitis C virus; IBD: inflammatory bowel disease; JAK: Janus kinase; NAFLD: nonalcoholic fatty liver disease; SD: standard deviation; UC: ulcerative colitis; 6-MP: 6-mercaptopurine.
Demographics
Sex	83			27			56
Female		41	49.4		13	48.2		28	50.0
Male		42	50.6		14	51.9		28	50.0
Age, mean (SD), years	83	56.9	18.5	27	49.0	12.7	56	60.7	19.7
Race	70			22			48
White		52	74.3		14	63.6		38	79.2
Black or African American		9	12.9		4	18.2		5	10.4
Asian		2	2.9		1	4.5		1	2.1
American Indian/native Alaskan		1	1.4		1	4.5		0	0
Multiracial		6	8.6		2	9.1		4	8.3
Ethnicity	61			21			40
Hispanic/Latino		7	11.5		4	19.0		3	7.5
Not Hispanic/Latino		54	88.5		17	81.0		37	92.5
Health characteristics
BMI^a	66			16			50
< 18.5 (underweight)		2	3.0		0	0		2	4.0
18.5 - 24.9 (normal weight)		22	33.3		4	25.0		18	36.0
25.0 - 29.9 (overweight)		16	24.2		5	31.3		11	22.0
30+ (obese)		26	39.4		7	43.8		19	38.0
Smoking status (cigarettes)	72			23			49
Current smoker		2	2.8		1	4.3		1	2.0
Prior smoker		14	19.4		2	8.7		12	24.5
Never smoker		56	77.8		20	87.0		36	73.5
IBD diagnosis	83			27			56
CD		46	55.4		17	63.0		29	51.8
UC		35	42.2		10	37.0		25	44.6
Indeterminate colitis		2	2.4		0	0		2	3.6
Comorbidities	83			27			56
AIDS		1	1.2		0	0		1	1.8
Anxiety		11	13.3		0	0		11	19.6
Asthma		4	4.8		1	3.7		3	5.4
Bipolar disorder		2	2.4		0	0		2	3.6
Cancer (current)^b		3	3.6		0	0		3	5.4
Colon cancer^c		2	2.4		0	0		2	3.6
Pancreatic cancer		1	1.2		0	0		1	1.8
Cancer (prior)^b		9	10.8		5	18.5		4	7.1
Breast cancer		2	2.4		2	7.4		0	0
Colon cancer		2	2.4		0	0		2	3.6
Lung cancer		1	1.2		0	0		1	1.8
Melanoma		1	1.2		1	3.7		0	0
Non-Hodgkin’s lymphoma		1	1.2		1	3.7		0	0
Prostate		1	1.2		1	3.7		0	0
Sarcoma		1	1.2		0	0		1	1.8
Cardiac arrest history		0	0		0	0		0	0
Cardiac arrhythmia		10	12.1		3	11.1		7	12.5
Chronic kidney disease		7	8.4		0	0		7	12.5
History of renal transplant and/or on dialysis		3	3.6		0	0		3	5.4
Chronic pain (other than fibromyalgia)		2	2.4		0	0		2	3.6
Cirrhosis		1	1.2		1	3.7		0	0
Congestive heart failure		4	4.8		0	0		4	7.1
COPD		2	2.4		0	0		2	3.6
CAD		9	10.8		1	3.7		8	14.3
Dementia		6	7.2		0	0		6	10.7
Depression		12	14.5		2	7.4		10	17.9
Diabetes (gestational)		2	2.4		1	3.7		1	1.8
Diabetes (type I)		4	4.8		0	0		4	7.1
Diabetes (type II)		17	20.5		4	14.8		13	23.2
DVT history		9	10.8		2	7.4		7	12.5
Fibromyalgia		3	3.6		1	3.7		2	3.6
HCV		1	1.2		1	3.7		0	0
Hypertension		34	40.1		7	25.9		27	48.2
Intellectual disability		1	1.2		0	0		1	1.8
Myocardial infarction history		1	1.2		0	0		1	1.8
NAFLD		1	1.2		1	3.7		0	0
Peripheral vascular disease		2	2.4		0	0		2	3.6
Primary sclerosing cholangitis		1	1.2		0	0		1	1.8
Pulmonary embolism history		6	7.2		1	3.7		5	8.9
Schizophrenia		5	6.0		1	3.7		4	7.1
Stroke history		4	4.8		1	3.7		3	5.4
IBD medications taken in 2020	82			26			56
No IBD meds taken in 2020		41	50.0		14	53.8		27	48.2
5-aminosalicylate
Mesalamine		24	29.3		7	26.9		17	30.4
Sulfasalazine		5	6.1		0	0		5	8.9
Antibiotics (only for IBD)
Ciprofloxacin		2	2.4		0	0		2	3.6
Metronidazole		2	2.4		0	0		2	3.6
Biologic therapy
Adalimumab (Humira)		5	6.1		2	7.7		3	5.4
Certolizumab pegol (Cimzia)		0	0		0	0		0	0
Golimumab (Simponi)		0	0		0	0		0	0
Infliximab (Remicade)		4	4.9		2	7.7		2	3.6
Infliximab biosimilar (Renflexis, Inflectra)		0	0		0	0		0	0
Natalizumab (Tysabri)		0	0		0	0		0	0
Ustekinumab (Stelara)		1	1.2		0	0		1	1.8
Vedolizumab (Entyvio)		3	3.7		1	3.8		2	3.6
Corticosteroids (only for IBD)
Budesonide (oral)		2	2.4		1	3.8		1	1.8
Prednisone or prednisolone (oral)		12	14.6		2	7.7		10	17.9
Rectal steroids		0	0		0	0		0	0
Immunomodulator
6-MP		0	0		0	0		0	0
Azathioprine		1	1.2		0	0		1	1.8
Cyclosporine		0	0		0	0		0	0
Methotrexate		0	0		0	0		0	0
Tacrolimus		0	0		0	0		0	0
Tofacitinib (JAK inhibitor)		1	1.2		0	0		1	1.8

Table 1. Demographics, Clinical Characteristics, and IBD Medications of All IBD/COVID-19 Patients and Patients Separated Into ED Visit Only and Hospitalized (n = 83)

All IBD/COVID-19 (n = 83)

IBD/COVID-19 patients with ED visit only (n = 27)

IBD/COVID-19 patients hospitalized (n = 56)

^aCalculated from first weight recorded in 2020. ^bExcluding non-melanoma skin cancer. ^cIncludes one colon cancer with brain metastases disease. AIDS: acquired immunodeficiency syndrome; BMI: body mass index; CAD: coronary artery disease; CD: Crohn’s disease; COVID-19: coronavirus disease 2019; DVT: deep vein thrombosis; ED: emergency department; HCV: hepatitis C virus; IBD: inflammatory bowel disease; JAK: Janus kinase; NAFLD: nonalcoholic fatty liver disease; SD: standard deviation; UC: ulcerative colitis; 6-MP: 6-mercaptopurine.

Demographics

Sex

Female

49.4

48.2

50.0

Male

50.6

51.9

50.0

Age, mean (SD), years

56.9

18.5

49.0

12.7

60.7

19.7

Race

White

74.3

63.6

79.2

Black or African American

12.9

18.2

10.4

Asian

2.9

4.5

2.1

American Indian/native Alaskan

1.4

4.5

Multiracial

8.6

9.1

8.3

Ethnicity

Hispanic/Latino

11.5

19.0

7.5

Not Hispanic/Latino

88.5

81.0

92.5

Health characteristics

BMI^a

< 18.5 (underweight)

3.0

4.0

18.5 - 24.9 (normal weight)

33.3

25.0

36.0

25.0 - 29.9 (overweight)

24.2

31.3

22.0

30+ (obese)

39.4

43.8

38.0

Smoking status (cigarettes)

Current smoker

2.8

4.3

2.0

Prior smoker

19.4

8.7

24.5

Never smoker

77.8

87.0

73.5

IBD diagnosis

55.4

63.0

51.8

42.2

37.0

44.6

Indeterminate colitis

2.4

3.6

Comorbidities

AIDS

1.2

1.8

Anxiety

13.3

19.6

Asthma

4.8

3.7

5.4

Bipolar disorder

2.4

3.6

Cancer (current)^b

3.6

5.4

Colon cancer^c

2.4

3.6

Pancreatic cancer

1.2

1.8

Cancer (prior)^b

10.8

18.5

7.1

Breast cancer

2.4

7.4

Colon cancer

2.4

3.6

Lung cancer

1.2

1.8

Melanoma

1.2

3.7

Non-Hodgkin’s lymphoma

1.2

3.7

Prostate

1.2

3.7

Sarcoma

1.2

1.8

Cardiac arrest history

Cardiac arrhythmia

12.1

11.1

12.5

Chronic kidney disease

8.4

12.5

History of renal transplant and/or on dialysis

3.6

5.4

Chronic pain (other than fibromyalgia)

2.4

3.6

Cirrhosis

1.2

3.7

Congestive heart failure

4.8

7.1

COPD

2.4

3.6

CAD

10.8

3.7

14.3

Dementia

7.2

10.7

Depression

14.5

7.4

17.9

Diabetes (gestational)

2.4

3.7

1.8

Diabetes (type I)

4.8

7.1

Diabetes (type II)

20.5

14.8

23.2

DVT history

10.8

7.4

12.5

Fibromyalgia

3.6

3.7

3.6

HCV

1.2

3.7

Hypertension

40.1

25.9

48.2

Intellectual disability

1.2

1.8

Myocardial infarction history

1.2

1.8

NAFLD

1.2

3.7

Peripheral vascular disease

2.4

3.6

Primary sclerosing cholangitis

1.2

1.8

Pulmonary embolism history

7.2

3.7

8.9

Schizophrenia

6.0

3.7

7.1

Stroke history

4.8

3.7

5.4

IBD medications taken in 2020

No IBD meds taken in 2020

50.0

53.8

48.2

5-aminosalicylate

Mesalamine

29.3

26.9

30.4

Sulfasalazine

6.1

8.9

Antibiotics (only for IBD)

Ciprofloxacin

2.4

3.6

Metronidazole

2.4

3.6

Biologic therapy

Adalimumab (Humira)

6.1

7.7

5.4

Certolizumab pegol (Cimzia)

Golimumab (Simponi)

Infliximab (Remicade)

4.9

7.7

3.6

Infliximab biosimilar (Renflexis, Inflectra)

Natalizumab (Tysabri)

Ustekinumab (Stelara)

1.2

1.8

Vedolizumab (Entyvio)

3.7

3.8

3.6

Corticosteroids (only for IBD)

Budesonide (oral)

2.4

3.8

1.8

Prednisone or prednisolone (oral)

14.6

7.7

17.9

Rectal steroids

Immunomodulator

6-MP

Azathioprine

1.2

1.8

Cyclosporine

Methotrexate

Tacrolimus

Tofacitinib (JAK inhibitor)

1.2

1.8

**Table 2.** Association Between Potential Risk Factors and Adverse Outcomes During COVID-19 Hospitalization
COVID-19 outcome	Risk factor	OR	95% CI	P value
^aAdalimumab and infliximab. ^bUnable to be calculated due to 0 cell count. No patients who had received corticosteroids for IBD died, stayed in the ICU, or were ventilated. ^cUnable to be calculated due to 0 cell count. No non-white patients stayed in the ICU or were ventilated. ^dDefined as an increase in serum creatinine by ≥ 0.3 mg/dL within 48 h or an increase in serum creatinine to ≥ 1.5 times baseline within the prior 7 days compared with the preceding 1 year of data in acute care medical records. Does not include patients with a pre-existing diagnosis of end-stage kidney disease. ^eComposite adverse outcomes variable included at least one of the following: death, ICU stay, mechanical ventilator use. CI: confidence interval; DVT: deep vein thrombosis; IBD: inflammatory bowel disease; COVID-19: coronavirus disease 2019; ICU: intensive care unit; OR: odds ratio; PE: pulmonary embolism; TNF: tumor necrosis factor; UC: ulcerative colitis.
Death	Demographics
	Age > 65 years	2.88	0.73 - 11.32	0.18
	Male sex	2.00	0.51 - 7.80	0.31
	Non-white race	0.49	0.05 - 4.54	1.00
	Health characteristics
	Obese	0.12	0.01 - 1.00	0.04
	Current or prior smoker	2.40	0.46 - 12.58	0.36
	UC IBD diagnosis	0.65	0.17 - 2.55	0.74
	Comorbidities
	Anxiety	0.35	0.04 - 3.07	0.43
	Depression	1.03	0.19 - 5.69	1.00
	Diabetes	0.40	0.08 - 2.10	0.47
	DVT and/or PE history	3.10	0.71 - 13.48	0.20
	Hypertension	0.87	0.23 - 3.27	0.84
	IBD medications
	No IBD medications	2.19	0.56 - 8.54	0.25
	Biologic therapy	1.78	0.30 - 10.67	0.61
	Anti-TNF biologic therapy^a	1.40	0.13 - 14.92	1.00
	5-aminosalicylates	0.28	0.05 - 1.43	0.17
	Corticosteroids	^b	^b	0.10
ICU stay	Demographics
	Age > 65 years	1.44	0.40 - 5.20	0.57
	Male sex	2.40	0.63 - 9.16	0.19
	Non-white race	^c	^c	0.17
	Health characteristics
	Obese	0.34	0.06 - 1.80	0.28
	Current or prior smoker	0.91	0.16 - 5.20	1.00
	UC IBD diagnosis	0.55	0.14 - 2.09	0.37
	Comorbidities
	Anxiety	1.50	0.33 - 6.82	0.69
	Depression	1.76	0.38 - 8.19	0.43
	Diabetes	0.64	0.15 - 2.74	0.73
	DVT and/or PE history	0.31	0.04 - 2.69	0.42
	Hypertension	1.10	0.31 - 3.93	0.89
	IBD medications
	No IBD medications	1.68	0.46 - 6.12	0.43
	Biologic therapy	0.58	0.06 - 5.31	1.00
	Anti-TNF biologic therapy^a	1.24	0.12 - 13.15	1.00
	5-aminosalicylates	0.44	0.10 - 1.84	0.33
	Corticosteroids	^b	^b	0.10
Mechanical ventilation	Demographics
	Age > 65 years	1.08	0.26 - 4.54	1.00
	Male sex	2.27	0.51 - 10.18	0.47
	Non-white race	^c	^c	0.32
	Health characteristics
	Obese	0.61	0.11 - 3.52	0.69
	Current or prior smoker	0.52	0.05 - 4.89	1.00
	UC IBD diagnosis	0.57	0.13 - 2.55	0.72
	Comorbidities
	Anxiety	1.21	0.21 - 6.81	1.00
	Depression	1.39	0.24 - 7.98	0.66
	Diabetes	0.55	0.10 - 2.98	0.70
	DVT and/or PE history	0.46	0.05 - 4.15	0.67
	Hypertension	0.83	0.20 - 3.50	1.00
	IBD medications
	No IBD medications	0.83	0.20 - 3.50	1.00
	Biologic therapy	0.85	0.09 - 8.09	1.00
	Anti-TNF biologic therapy^a	1.83	0.17 - 19.91	0.51
	5-aminosalicylates	0.74	0.16 - 3.31	1.00
	Corticosteroids	^b	^b	0.18
Composite adverse outcomes variable^e	Demographics
	Age > 65 years	2.14	0.66 - 6.95	0.20
	Male sex	2.04	0.62 - 6.69	0.24
	Non-white race	0.24	0.03 - 2.12	0.25
	Health characteristics
	Obese	0.19	0.04 - 0.95	0.03
	Current or prior smoker	1.84	0.44 - 7.76	0.45
	UC IBD diagnosis	0.66	0.20 - 2.17	0.50
	Comorbidities
	Anxiety	0.92	0.21 - 4.04	1.00
	Depression	1.89	0.45 - 7.86	0.45
	Diabetes	0.38	0.09 - 1.57	0.17
	DVT and/or PE history	1.57	0.39 - 6.34	0.71
	Hypertension	0.54	0.17 - 1.78	0.31
	IBD medications
	No IBD medications	2.25	0.69 - 7.42	0.18
	Biologic therapy	1.00	0.17 - 5.77	1.00
	Anti-TNF biologic therapy^a	0.82	0.08 - 8.55	1.00
	5-aminosalicylates	0.41	0.11 - 1.48	0.17
	Corticosteroids	^b	^b	0.02

Table 2. Association Between Potential Risk Factors and Adverse Outcomes During COVID-19 Hospitalization

COVID-19 outcome

Risk factor

95% CI

P value

^aAdalimumab and infliximab. ^bUnable to be calculated due to 0 cell count. No patients who had received corticosteroids for IBD died, stayed in the ICU, or were ventilated. ^cUnable to be calculated due to 0 cell count. No non-white patients stayed in the ICU or were ventilated. ^dDefined as an increase in serum creatinine by ≥ 0.3 mg/dL within 48 h or an increase in serum creatinine to ≥ 1.5 times baseline within the prior 7 days compared with the preceding 1 year of data in acute care medical records. Does not include patients with a pre-existing diagnosis of end-stage kidney disease. ^eComposite adverse outcomes variable included at least one of the following: death, ICU stay, mechanical ventilator use. CI: confidence interval; DVT: deep vein thrombosis; IBD: inflammatory bowel disease; COVID-19: coronavirus disease 2019; ICU: intensive care unit; OR: odds ratio; PE: pulmonary embolism; TNF: tumor necrosis factor; UC: ulcerative colitis.

Death

Demographics

Age > 65 years

2.88

0.73 - 11.32

0.18

Male sex

2.00

0.51 - 7.80

0.31

Non-white race

0.49

0.05 - 4.54

1.00

Health characteristics

Obese

0.12

0.01 - 1.00

0.04

Current or prior smoker

2.40

0.46 - 12.58

0.36

UC IBD diagnosis

0.65

0.17 - 2.55

0.74

Comorbidities

Anxiety

0.35

0.04 - 3.07

0.43

Depression

1.03

0.19 - 5.69

1.00

Diabetes

0.40

0.08 - 2.10

0.47

DVT and/or PE history

3.10

0.71 - 13.48

0.20

Hypertension

0.87

0.23 - 3.27

0.84

IBD medications

No IBD medications

2.19

0.56 - 8.54

0.25

Biologic therapy

1.78

0.30 - 10.67

0.61

Anti-TNF biologic therapy^a

1.40

0.13 - 14.92

1.00

5-aminosalicylates

0.28

0.05 - 1.43

0.17

Corticosteroids

0.10

ICU stay

Demographics

Age > 65 years

1.44

0.40 - 5.20

0.57

Male sex

2.40

0.63 - 9.16

0.19

Non-white race

0.17

Health characteristics

Obese

0.34

0.06 - 1.80

0.28

Current or prior smoker

0.91

0.16 - 5.20

1.00

UC IBD diagnosis

0.55

0.14 - 2.09

0.37

Comorbidities

Anxiety

1.50

0.33 - 6.82

0.69

Depression

1.76

0.38 - 8.19

0.43

Diabetes

0.64

0.15 - 2.74

0.73

DVT and/or PE history

0.31

0.04 - 2.69

0.42

Hypertension

1.10

0.31 - 3.93

0.89

IBD medications

No IBD medications

1.68

0.46 - 6.12

0.43

Biologic therapy

0.58

0.06 - 5.31

1.00

Anti-TNF biologic therapy^a

1.24

0.12 - 13.15

1.00

5-aminosalicylates

0.44

0.10 - 1.84

0.33

Corticosteroids

0.10

Mechanical ventilation

Demographics

Age > 65 years

1.08

0.26 - 4.54

1.00

Male sex

2.27

0.51 - 10.18

0.47

Non-white race

0.32

Health characteristics

Obese

0.61

0.11 - 3.52

0.69

Current or prior smoker

0.52

0.05 - 4.89

1.00

UC IBD diagnosis

0.57

0.13 - 2.55

0.72

Comorbidities

Anxiety

1.21

0.21 - 6.81

1.00

Depression

1.39

0.24 - 7.98

0.66

Diabetes

0.55

0.10 - 2.98

0.70

DVT and/or PE history

0.46

0.05 - 4.15

0.67

Hypertension

0.83

0.20 - 3.50

1.00

IBD medications

No IBD medications

0.83

0.20 - 3.50

1.00

Biologic therapy

0.85

0.09 - 8.09

1.00

Anti-TNF biologic therapy^a

1.83

0.17 - 19.91

0.51

5-aminosalicylates

0.74

0.16 - 3.31

1.00

Corticosteroids

0.18

Composite adverse outcomes variable^e

Demographics

Age > 65 years

2.14

0.66 - 6.95

0.20

Male sex

2.04

0.62 - 6.69

0.24

Non-white race

0.24

0.03 - 2.12

0.25

Health characteristics

Obese

0.19

0.04 - 0.95

0.03

Current or prior smoker

1.84

0.44 - 7.76

0.45

UC IBD diagnosis

0.66

0.20 - 2.17

0.50

Comorbidities

Anxiety

0.92

0.21 - 4.04

1.00

Depression

1.89

0.45 - 7.86

0.45

Diabetes

0.38

0.09 - 1.57

0.17

DVT and/or PE history

1.57

0.39 - 6.34

0.71

Hypertension

0.54

0.17 - 1.78

0.31

IBD medications

No IBD medications

2.25

0.69 - 7.42

0.18

Biologic therapy

1.00

0.17 - 5.77

1.00

Anti-TNF biologic therapy^a

0.82

0.08 - 8.55

1.00

5-aminosalicylates

0.41

0.11 - 1.48

0.17

Corticosteroids

0.02