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. Author manuscript; available in PMC: 2021 May 1.
Published in final edited form as: Clin Gastroenterol Hepatol. 2019 Oct 30;18(6):1268–1279. doi: 10.1016/j.cgh.2019.10.035

Table 3.

Incidence rate of serious infections and malignancy (per 100-PY) in patients with moderate to severe IBD treated with pharmacotherapy [Abbreviations: SI-serious infections; TNFα-Tumor necrosis factorα]

Drug Class Clinical Trials &
Open Label
Extensions
(per 100-PY)		 Safety Registries
(per 100-PY)		 Real-World
Observational Studies
(per 100-PY)
TNFα antagonists SI: 3.4–6.1 Malignancy: 0.45 SI: 2.2–4.7 Malignancy: 0.64–0.8 SI: 1.9–10.9 Malignancy: 0.43 (lymphoma, 0.04)
Vedolizumab SI: 4.3 Malignancy: 0.50 - SI: 5.2 Malignancy: 0.23
Ustekinumab SI: 5.5 Malignancy: 0.4 (SI: 0.9–1.5 in psoriasis) -