Table 1.

Demographic and clinical characteristics of IBD patients on vedolizumab compared with other IBD therapies in the SECURE-IBD registry

Characteristica,bAll patients on ≥1 medication and ≥18 years of ageVedolizumabOther IBD therapyp-valuec
N%N%N%
Total number of patients364745712.5%319087.5%
Age
 Mean [SD]42.216.443.817.8242.016.120.031
 Median [IQ range]4029.0, 53.04029.0, 55.04029.0, 53.00.137
Female sex184750.6%23952.3%160850.4%0.450
Race
 Reported at least selected one race362099.3%45499.3%316699.2%1.000
 White298381.8%39386.0%259081.2%0.013
 Black or African American1754.8%224.8%1534.8%0.987
 American Indian/Native Alaskan80.2%00.0%80.3%0.607
 Asian1674.6%81.8%1595.0%0.002
 Native Hawaiian/Pacific Islander10.0%00.0%10.0%1.000
 Other2055.6%183.9%1875.9%0.095
 Unknown1845.0%204.4%1645.1%0.485
Hispanic/Latino<0.001
 Yes52414.4%5010.9%47414.9%
 No249368.4%34976.4%214467.2%
 Unknown40311.1%316.8%37211.7%
 Missing2276.2%275.9%2006.3%
Reporting country
 USA131936.2%20945.7%111034.8%<0.001
 Spain2797.7%245.3%2558.0%0.039
 Russian Federation2617.2%378.1%2247.0%0.405
 UK1564.3%163.5%1404.4%0.380
 France1062.9%102.2%963.0%0.328
 Italy1504.1%235.0%1274.0%0.290
 Brazil1012.8%92.0%922.9%0.265
 Iran, Islamic Republic of511.4%00.0%511.6%0.006
 Belgium1363.7%224.8%1143.6%0.191
 Argentina591.6%40.9%551.7%0.179
 Germany992.7%204.4%792.5%0.019
 Turkey732.0%71.5%662.1%0.443
 Netherlands1584.3%132.8%1454.5%0.095
 Canada631.7%71.5%561.8%0.731
 Other63617.4%5612.3%58018.2%0.002
Disease type:<0.001
 Crohn’s disease204956.2%20144.0%184857.9%
 Ulcerative colitis152741.9%24653.8%128140.2%
 IBD unspecified571.6%81.8%491.5%
IBD disease activityd0.149
 Remission198254.3%22849.9%175455.0%
 Mild79221.7%10422.8%68821.6%
 Moderate/severe72019.7%10322.5%61719.3%
Smoking1454.0%122.6%1334.2%0.114
Comorbidity summary score0.194
 0251769.0%32070.0%219768.9%
 177221.2%8318.2%68921.6%
 22085.7%337.2%1755.5%
 ≥31504.1%214.6%1294.0%
Cardiovascular disease2065.6%255.5%1815.7%0.860
Diabetes1784.9%235.0%1554.9%0.872
Asthma1774.9%296.3%1484.6%0.112
COPD501.4%71.5%431.3%0.752
Other chronic lung disease501.4%51.1%451.4%0.586
Hypertension37810.4%419.0%33710.6%0.296
Cancer561.5%92.0%471.5%0.420
History of stroke330.9%30.7%300.9%0.791
Chronic renal disease711.9%132.8%581.8%0.137
Chronic liver disease1052.9%173.7%882.8%0.250
Other comorbidity41211.3%5812.7%35411.1%0.314
BMI0.280
 BMI < 30244066.9%32070.0%212066.5%
 BMI ≥ 3060916.7%7215.8%53716.8%
 Missing59816.4%6514.2%53316.7%
Characteristica,bAll patients on ≥1 medication and ≥18 years of ageVedolizumabOther IBD therapyp-valuec
N%N%N%
Total number of patients364745712.5%319087.5%
Age
 Mean [SD]42.216.443.817.8242.016.120.031
 Median [IQ range]4029.0, 53.04029.0, 55.04029.0, 53.00.137
Female sex184750.6%23952.3%160850.4%0.450
Race
 Reported at least selected one race362099.3%45499.3%316699.2%1.000
 White298381.8%39386.0%259081.2%0.013
 Black or African American1754.8%224.8%1534.8%0.987
 American Indian/Native Alaskan80.2%00.0%80.3%0.607
 Asian1674.6%81.8%1595.0%0.002
 Native Hawaiian/Pacific Islander10.0%00.0%10.0%1.000
 Other2055.6%183.9%1875.9%0.095
 Unknown1845.0%204.4%1645.1%0.485
Hispanic/Latino<0.001
 Yes52414.4%5010.9%47414.9%
 No249368.4%34976.4%214467.2%
 Unknown40311.1%316.8%37211.7%
 Missing2276.2%275.9%2006.3%
Reporting country
 USA131936.2%20945.7%111034.8%<0.001
 Spain2797.7%245.3%2558.0%0.039
 Russian Federation2617.2%378.1%2247.0%0.405
 UK1564.3%163.5%1404.4%0.380
 France1062.9%102.2%963.0%0.328
 Italy1504.1%235.0%1274.0%0.290
 Brazil1012.8%92.0%922.9%0.265
 Iran, Islamic Republic of511.4%00.0%511.6%0.006
 Belgium1363.7%224.8%1143.6%0.191
 Argentina591.6%40.9%551.7%0.179
 Germany992.7%204.4%792.5%0.019
 Turkey732.0%71.5%662.1%0.443
 Netherlands1584.3%132.8%1454.5%0.095
 Canada631.7%71.5%561.8%0.731
 Other63617.4%5612.3%58018.2%0.002
Disease type:<0.001
 Crohn’s disease204956.2%20144.0%184857.9%
 Ulcerative colitis152741.9%24653.8%128140.2%
 IBD unspecified571.6%81.8%491.5%
IBD disease activityd0.149
 Remission198254.3%22849.9%175455.0%
 Mild79221.7%10422.8%68821.6%
 Moderate/severe72019.7%10322.5%61719.3%
Smoking1454.0%122.6%1334.2%0.114
Comorbidity summary score0.194
 0251769.0%32070.0%219768.9%
 177221.2%8318.2%68921.6%
 22085.7%337.2%1755.5%
 ≥31504.1%214.6%1294.0%
Cardiovascular disease2065.6%255.5%1815.7%0.860
Diabetes1784.9%235.0%1554.9%0.872
Asthma1774.9%296.3%1484.6%0.112
COPD501.4%71.5%431.3%0.752
Other chronic lung disease501.4%51.1%451.4%0.586
Hypertension37810.4%419.0%33710.6%0.296
Cancer561.5%92.0%471.5%0.420
History of stroke330.9%30.7%300.9%0.791
Chronic renal disease711.9%132.8%581.8%0.137
Chronic liver disease1052.9%173.7%882.8%0.250
Other comorbidity41211.3%5812.7%35411.1%0.314
BMI0.280
 BMI < 30244066.9%32070.0%212066.5%
 BMI ≥ 3060916.7%7215.8%53716.8%
 Missing59816.4%6514.2%53316.7%

Abbreviations: COVID-19 = Coronavirus Disease 2019; ICU = intensive care unit; COPD = chronic obstructive pulmonary disease; IBD = inflammatory bowel disease; PSC = primary sclerosing cholangitis; NAFLD = non-alcoholic fatty liver disease.

aUnless otherwise specified, percentages do not include missing values or ‘unknown’. For all characteristics, unless noted above, less than 4% of data were missing and unknown, respectively, for each category.

bPercentages and n from each subcategory may not add up to the exact number of total reported cases due to missing values and/or non-mutually exclusive variables.

cp-values for tests comparing variables between vedolizumab and other medication groups.

dBy physician global assessment [PGA] at the time of COVID-19 infection.

Table 1.

Demographic and clinical characteristics of IBD patients on vedolizumab compared with other IBD therapies in the SECURE-IBD registry

Characteristica,bAll patients on ≥1 medication and ≥18 years of ageVedolizumabOther IBD therapyp-valuec
N%N%N%
Total number of patients364745712.5%319087.5%
Age
 Mean [SD]42.216.443.817.8242.016.120.031
 Median [IQ range]4029.0, 53.04029.0, 55.04029.0, 53.00.137
Female sex184750.6%23952.3%160850.4%0.450
Race
 Reported at least selected one race362099.3%45499.3%316699.2%1.000
 White298381.8%39386.0%259081.2%0.013
 Black or African American1754.8%224.8%1534.8%0.987
 American Indian/Native Alaskan80.2%00.0%80.3%0.607
 Asian1674.6%81.8%1595.0%0.002
 Native Hawaiian/Pacific Islander10.0%00.0%10.0%1.000
 Other2055.6%183.9%1875.9%0.095
 Unknown1845.0%204.4%1645.1%0.485
Hispanic/Latino<0.001
 Yes52414.4%5010.9%47414.9%
 No249368.4%34976.4%214467.2%
 Unknown40311.1%316.8%37211.7%
 Missing2276.2%275.9%2006.3%
Reporting country
 USA131936.2%20945.7%111034.8%<0.001
 Spain2797.7%245.3%2558.0%0.039
 Russian Federation2617.2%378.1%2247.0%0.405
 UK1564.3%163.5%1404.4%0.380
 France1062.9%102.2%963.0%0.328
 Italy1504.1%235.0%1274.0%0.290
 Brazil1012.8%92.0%922.9%0.265
 Iran, Islamic Republic of511.4%00.0%511.6%0.006
 Belgium1363.7%224.8%1143.6%0.191
 Argentina591.6%40.9%551.7%0.179
 Germany992.7%204.4%792.5%0.019
 Turkey732.0%71.5%662.1%0.443
 Netherlands1584.3%132.8%1454.5%0.095
 Canada631.7%71.5%561.8%0.731
 Other63617.4%5612.3%58018.2%0.002
Disease type:<0.001
 Crohn’s disease204956.2%20144.0%184857.9%
 Ulcerative colitis152741.9%24653.8%128140.2%
 IBD unspecified571.6%81.8%491.5%
IBD disease activityd0.149
 Remission198254.3%22849.9%175455.0%
 Mild79221.7%10422.8%68821.6%
 Moderate/severe72019.7%10322.5%61719.3%
Smoking1454.0%122.6%1334.2%0.114
Comorbidity summary score0.194
 0251769.0%32070.0%219768.9%
 177221.2%8318.2%68921.6%
 22085.7%337.2%1755.5%
 ≥31504.1%214.6%1294.0%
Cardiovascular disease2065.6%255.5%1815.7%0.860
Diabetes1784.9%235.0%1554.9%0.872
Asthma1774.9%296.3%1484.6%0.112
COPD501.4%71.5%431.3%0.752
Other chronic lung disease501.4%51.1%451.4%0.586
Hypertension37810.4%419.0%33710.6%0.296
Cancer561.5%92.0%471.5%0.420
History of stroke330.9%30.7%300.9%0.791
Chronic renal disease711.9%132.8%581.8%0.137
Chronic liver disease1052.9%173.7%882.8%0.250
Other comorbidity41211.3%5812.7%35411.1%0.314
BMI0.280
 BMI < 30244066.9%32070.0%212066.5%
 BMI ≥ 3060916.7%7215.8%53716.8%
 Missing59816.4%6514.2%53316.7%
Characteristica,bAll patients on ≥1 medication and ≥18 years of ageVedolizumabOther IBD therapyp-valuec
N%N%N%
Total number of patients364745712.5%319087.5%
Age
 Mean [SD]42.216.443.817.8242.016.120.031
 Median [IQ range]4029.0, 53.04029.0, 55.04029.0, 53.00.137
Female sex184750.6%23952.3%160850.4%0.450
Race
 Reported at least selected one race362099.3%45499.3%316699.2%1.000
 White298381.8%39386.0%259081.2%0.013
 Black or African American1754.8%224.8%1534.8%0.987
 American Indian/Native Alaskan80.2%00.0%80.3%0.607
 Asian1674.6%81.8%1595.0%0.002
 Native Hawaiian/Pacific Islander10.0%00.0%10.0%1.000
 Other2055.6%183.9%1875.9%0.095
 Unknown1845.0%204.4%1645.1%0.485
Hispanic/Latino<0.001
 Yes52414.4%5010.9%47414.9%
 No249368.4%34976.4%214467.2%
 Unknown40311.1%316.8%37211.7%
 Missing2276.2%275.9%2006.3%
Reporting country
 USA131936.2%20945.7%111034.8%<0.001
 Spain2797.7%245.3%2558.0%0.039
 Russian Federation2617.2%378.1%2247.0%0.405
 UK1564.3%163.5%1404.4%0.380
 France1062.9%102.2%963.0%0.328
 Italy1504.1%235.0%1274.0%0.290
 Brazil1012.8%92.0%922.9%0.265
 Iran, Islamic Republic of511.4%00.0%511.6%0.006
 Belgium1363.7%224.8%1143.6%0.191
 Argentina591.6%40.9%551.7%0.179
 Germany992.7%204.4%792.5%0.019
 Turkey732.0%71.5%662.1%0.443
 Netherlands1584.3%132.8%1454.5%0.095
 Canada631.7%71.5%561.8%0.731
 Other63617.4%5612.3%58018.2%0.002
Disease type:<0.001
 Crohn’s disease204956.2%20144.0%184857.9%
 Ulcerative colitis152741.9%24653.8%128140.2%
 IBD unspecified571.6%81.8%491.5%
IBD disease activityd0.149
 Remission198254.3%22849.9%175455.0%
 Mild79221.7%10422.8%68821.6%
 Moderate/severe72019.7%10322.5%61719.3%
Smoking1454.0%122.6%1334.2%0.114
Comorbidity summary score0.194
 0251769.0%32070.0%219768.9%
 177221.2%8318.2%68921.6%
 22085.7%337.2%1755.5%
 ≥31504.1%214.6%1294.0%
Cardiovascular disease2065.6%255.5%1815.7%0.860
Diabetes1784.9%235.0%1554.9%0.872
Asthma1774.9%296.3%1484.6%0.112
COPD501.4%71.5%431.3%0.752
Other chronic lung disease501.4%51.1%451.4%0.586
Hypertension37810.4%419.0%33710.6%0.296
Cancer561.5%92.0%471.5%0.420
History of stroke330.9%30.7%300.9%0.791
Chronic renal disease711.9%132.8%581.8%0.137
Chronic liver disease1052.9%173.7%882.8%0.250
Other comorbidity41211.3%5812.7%35411.1%0.314
BMI0.280
 BMI < 30244066.9%32070.0%212066.5%
 BMI ≥ 3060916.7%7215.8%53716.8%
 Missing59816.4%6514.2%53316.7%

Abbreviations: COVID-19 = Coronavirus Disease 2019; ICU = intensive care unit; COPD = chronic obstructive pulmonary disease; IBD = inflammatory bowel disease; PSC = primary sclerosing cholangitis; NAFLD = non-alcoholic fatty liver disease.

aUnless otherwise specified, percentages do not include missing values or ‘unknown’. For all characteristics, unless noted above, less than 4% of data were missing and unknown, respectively, for each category.

bPercentages and n from each subcategory may not add up to the exact number of total reported cases due to missing values and/or non-mutually exclusive variables.

cp-values for tests comparing variables between vedolizumab and other medication groups.

dBy physician global assessment [PGA] at the time of COVID-19 infection.

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