Response to Dai et al

We would like to thank Dr. Dai and colleagues for their insightful comments on our article (1,2). They suggested that the increased risk of serious infections observed in vedolizumab-treated patients with Crohn's disease (CD), compared with those treated with anti-tumor necrosis factor agents (anti-TNFs), had not been seen in previous studies. Although it is true that some studies have not identified significant differences in treatment-associated risks, most studies demonstrate non-statistically significant increased risks of infections in patients with CD. We caution readers against concluding that there is no association based solely on P-values >0.0