Table 2.

C. difficile and CMV outcomes by biologic group

CDI Outcomes	Vedolizumab	Anti-TNFα	P-value†
CDI, incidence rate (per 1,000 patient-years)	5.6	37.9	0.001
Severe CDI, incidence rate (per 1,000 patient-years)	2.8	10.2	0.18
CDI hospitalization, incidence rate (per 1,000 patient-years)	5.6	21.3	0.042
Colectomy within 30 days after CDI, fraction (%)‡	0/2 (0.0%)	1/41 (2.4%)	1.00
Death within 30 days after CDI, fraction (%)‡	0/2 (0.0%)	0/41 (0.0%)	1.00
Antibiotics within 30 days prior to CDI, fraction (%)‡	0/2 (0.0%)	3/41 (7.3%)	1.00
Systemic corticosteroids within 30 days prior to CDI, fraction (%)‡	1/2 (50.0%)	28/41 (68.3%)	1.00
CMV Outcomes	Vedolizumab	Anti-TNFα	--
CMVC, incidence rate (per 1,000 patient-years)	0	4.5	--
CMVC hospitalization, incidence rate (per 1,000 patient-years)	0	3.6	--
Colectomy within 30 days after CMVC, fraction (%)§	--	1/5 (20.0%)	--
Death within 30 days after CMVC, fraction (%)§	--	0/5 (0.0%)	--

^†All p-values were calculated using Fisher’s exact test for categorical data except for CDI, severe CDI, CDI hospitalization, which were calculated using the log-rank test. Due to the small number of CMVC outcomes, p-values were not calculated to compare biologic groups.

^‡Denominator for these outcomes includes only patients who developed CDI (i.e. n=2 for vedolizumab, n=41 for anti-TNFα)

^§Denominator for these outcomes includes only patients who developed CMVC (i.e. n=5 for anti-TNFα only)

Abbreviations: TNF = tumor necrosis factor, CDI = C. difficile infection, CMVC = cytomegalovirus colitis