Citations

SummaryBackgroundUp to 80% of patients with Crohn's disease require an abdominal operation in their lifetime. As the use of vedolizumab is increasing for the treatment of Crohn's disease, it is important to understand its potential association with post‐operative complications.AimWe sought to compare 30‐day postoperative infectious complication rate among vedolizumab‐treated Crohn's disease patients vs those who had received TNFα inhibitors or no biologic therapy.MethodsA retrospective review of all Crohn's disease patients who received vedolizumab within 12 weeks of a major abdominal or pelvic operation was performed. Two control cohorts consisted of Crohn's disease patients treated with TNFα inhibitors or no biologic therapy.ResultsOne hundred Crohn's disease patients received vedolizumab within 12 weeks of an abdominal operation. Vedolizumab‐treated patients underwent an equivalent rate of laparoscopic surgery (P = .25), had fewer anastomoses performed (P = .0002), and had equally frequent diversion in the setting of anastomoses (P = .47). Thirty‐two vedolizumab‐treated patients experienced postoperative infectious complications (32%), 26 of which were surgical site infections (26%). The vedolizumab‐treated group experienced no difference in nonsurgical site infections (6% vs 5% anti‐TNFα and 2% nonbiologic; P = .34), but significantly higher rates of surgical site infections (26% vs 8% and 11%; P < .001). On univariate and multivariate analysis, exposure to vedolizumab remained a significant predictor of postoperative surgical site infection (P < .001 and P = .002).ConclusionsTwenty‐six per cent of Crohn's disease patients who received vedolizumab within 12 weeks prior to a major abdominal operation experienced a 30‐day postoperative surgical site infection, significantly higher than that of patients receiving TNFα inhibitors or no biologic therapy. Vedolizumab within 12 weeks of surgery remained a predictor of 30‐day postoperative surgical site infection on multivariable analysis. While vedolizumab‐treated Crohn's disease patients may be a sicker cohort of patients, it is important to consider these findings with regard to preoperative counselling, operative timing and primary closure of wounds.

SummaryBackgroundThere are conflicting data on comparative effectiveness of adalimumab and infliximab in patients with Crohn's disease (CD).AimsTo compare the effectiveness and safety of adalimumab and infliximab in biologic‐naïve patients with CD, in a nationwide register‐based propensity score‐matched cohort study in Denmark.MethodsA total of 2908 Danish adults with CD had been treated with adalimumab or infliximab as their first biologic agent between 2005‐2014. By Cox regression, we compared rates of all‐cause hospitalisation, CD‐related hospitalisation, major abdominal surgery and serious infections after variable 2:1 propensity score matching, accounting for baseline disease characteristics, healthcare utilisation and use of CD‐related medications.ResultsAfter propensity‐score matching, we included 315 adalimumab‐ (34.9 ± 12.9 years, 41.9% males) and 512 infliximab‐treated (33.6 ± 12.6 years, 40.8% males) patients, with median disease duration 4.0 years; 36.9% had prior abdominal surgery. Over a median follow‐up 2.3 years after starting biological therapy, there were no significant differences in rate of CD‐related hospitalisation (hazard ratio [HR], 0.81 [95% CI, 0.55‐1.20]) or major abdominal surgery (HR, 1.24 [0.66‐2.33]) between adalimumab‐ and infliximab‐treated patients, though rate of all‐cause hospitalisation was lower in adalimumab‐treated patients (HR, 0.74 [0.56‐0.97]). There was no significant difference in incidence of serious infections requiring hospitalisation (HR, 1.06 [0.26‐4.21]). These results were stable in patients treated with biological monotherapy (all‐cause hospitalisation: HR, 0.75 [0.53‐1.05]; CD‐related hospitalisation: HR, 0.82 [0.51‐1.32], abdominal surgery: HR, 1.47 [0.63‐3.47]) or in combination with immunomodulators (all‐cause hospitalisation: HR, 0.70 [0.44‐1.11]; CD‐related hospitalisation: HR, 0.80 [0.42‐1.52], abdominal surgery: HR, 1.02 [0.39‐2.64]).ConclusionsIn this population‐based, propensity score matched, real‐life cohort study using administrative claims, there was no significant difference in effectiveness and safety of adalimumab and infliximab in biologic‐naïve patients with CD.