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ObjectiveAnti-tumor necrosis factor (anti-TNF) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti-TNF agents are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF agent approved for the treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This analysis was undertaken to evaluate pregnancy outcomes in women receiving CZP, especially those exposed during early pregnancy.MethodsProspective and retrospective data on maternal CZP exposure were extracted from the UCB Pharma safety database through March 6, 2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. The numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained.ResultsOf 1,137 prospectively reported pregnancies with maternal exposure to CZP, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred in 367 (81.2%) of 452 pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred in 201 (44.5%) of 452 pregnancies.ConclusionThis analysis represents the largest cohort of pregnant women exposed to an anti-TNF agent for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP.

Background: Surgery is common in patients with Crohn's disease and can contribute significantly to patient morbidity. The National Surgical Quality Improvement Program surgical risk calculator (NSQIP-SRC) that is currently utilized to predict surgical risk does not take Crohn's disease into account and, as a result, seems to underestimate risk in this patient population. This study aimed to evaluate the accuracy of the NSQIP-SRC in Crohn's disease patients and to evaluate the utility of disease severity scores in predicting surgical risk.Methods: Between 2011 and 2017, there were 176 surgical cases involving Crohn's disease patients. Demographic data and 30-day surgical outcomes were collected. Disease severity scores including Harvey Bradshaw Index (HBI), Crohn's Disease Activity Index (CDAI), Simple Endoscopic Score for Crohn's Disease (SES-CD), and NSQIP-SRC risk percentages were calculated.Results: Patients in remission based on HBI had a complication rate of 8.57% (n = 3), while those with mild or moderate-severe disease had rates of 33.33% (n = 11) and 38.46% (n = 20) respectively (p = 0.0045). In multivariable analysis, those with mild (OR; 8.37, 95% CI; 1.64, 42.78; p = 0.011) or moderate-severe (OR; 11.69, 95% CI; 2.42, 56.46; p = 0.002) disease had increased odds of complication compared to remission. Complication rate was not associated with NSQIP-SRC percent risk of any complication.Conclusion: NSQIP-SRC does not accurately predict risk in patients with CD undergoing surgery. Higher disease activity based on HBI is associated with increased odds of complication and may prove to be more predictive of surgical complication in the Crohn's patient population. [ABSTRACT FROM AUTHOR]

Purpose Infliximab promotes remission in patients with inflammatory bowel disease (IBD) and rheumatologic disease (RD). Rapid infliximab infusions (RI) reduce infusion time from 2 hours to 1 hour and can enhance access to care, as defined by capacity, safety, and patient characteristics. Our hypothesis for the study described here was that use of RI can enhance access for patients. Methods Data on all patients receiving infliximab for IBD or RD at our outpatient infusion center from February 2016 to August 2017 were retrospectively analyzed. Demographic and clinical information were collected. Results Of 348 patients who received infliximab, 205 had IBD and 143 had RD. In terms of capacity, 40% of patients received RI, resulting in a 16.1% decrease in average daily infusion time and a 9.8% increase in average daily available scheduled infusion chair time (P = 0.720). In terms of safety, 4 patients switched back to standard infusions after RI, after 3 specifically had reactions to RI. In terms of patient characteristics, more patients with RD versus IBD received RI (P = 0.020). Among the patients with RD, a lower proportion receiving RI were female (P = 0.043). For the patients with IBD, a higher proportion receiving RI were White (P = 0.048). Among both patients with RD and patients with IBD, a higher proportion receiving RI had private insurance (P = 0.016 and P = 0.018, respectively). Conclusion RI were safe and increased available chair time. Females with RD, patients of non-White race with IBD, and patients with public insurance were less likely to receive RI. Future directions include patient surveys and evaluation of implicit bias against patient factors that may impact access to RI. [ABSTRACT FROM AUTHOR]