Table 3.

Risk of serious infections, overall, and by organ type in patients treated with vedolizumab vs. TNFα antagonists (reference), using marginal structural models. Estimates highlighted in bold are statistically significant.

Vedolizumab vs. TNFα antagonists (reference),	All serious infections	Extra-intestinal serious infections	Gastrointestinal serious infections
adjusted HR (and 95% CI)
All patients with IBD	0.79 (0.56–1.13)	0.81 (0.45–1.43)	1.82 (1.08–3.07)
IBD phenotype  • Crohn’s disease  • Ulcerative colitis	1.30 (0.80–2.11) 0.54 (0.35–0.83)	1.43 (0.73–2.79) 0.41 (0.15–1.12)	2.90 (1.21–6.94) 1.20 (0.57–2.53)
Age at biologic initiation  • ≥60y  • <60y	0.79 (0.38–1.62) 0.77 (0.52–1.16)	0.68 (0.19–2.38) 0.74 (0.37–1.51)	2.92 (0.90–9.43) 1.04 (0.44–2.43)
Excluding patients with serious infection in preceding 12m	0.78 (0.53–1.14)	0.75 (0.41–1.36)	1.87 (1.07–3.28)
Excluding patients with immunomodulator exposure in preceding 12m	0.89 (0.63–1.25)	0.98 (0.51–1.88)	1.80 (0.89–3.62)

[Abbreviations: CI=confidence interval, HR=hazard ratio, TNF=tumor necrosis factor]