An Update on Anti-TNF Biosimilar Switching-Real-World Clinical Effectiveness and Safety.

Background: Biological medications for inflammatory bowel disease (IBD) account for a significant burden on provincial budgets. In an effort to curb these rising costs, nationwide switching to biosimilars is expected to be complete in Canada before the end of 2023. Biosimilar products do not require the same rigor for licensing as the originator and therefore there has been appropriate scepticism as to how biosimilars will perform in real-world practice. Methods: We have performed a systematic review including real-world observational studies of adult patients with IBD. The primary outcome was clinical effectiveness and/or safety in patients who had switched from originator to biosimilar anti-TNF. Secondary outcomes included loss of response (LOR), treatment persistence or cessation and immunogenicity. Results: We included 43 studies (7,462 patients [70 percent Crohn's disease: 30 percent ulcerative colitis]; 32 infliximab studies, and 11 adalimumab studies). For infliximab, 75 percent patients were in clinical remission at the time of switch and 75 percent maintained clinical remission beyond 12 months, compared to 78 percent of patients who continued originator. For adalimumab, 86 percent patients were in remission at the time of switch with 82 percent maintaining remission at 6 months follow-up. Injection site pain was higher in patients who switched to a citrate containing adalimumab biosimilar, compared with those who continued originator. All other outcomes (LOR, treatment cessation or persistence and serious adverse events) were similar to patients who continued originator (in comparator cohorts or the available literature). Conclusion: Whilst ongoing vigilance is required, these data are reassuring to both patients and clinicians and will significantly help to reduce health-care costs across Canada.

The Fundamentals of Inflammatory Bowel Disease Management in Pregnancy: A Practical Review for the Gastroenterologist.

This narrative review explores the management of Inflammatory Bowel Disease (IBD) during pregnancy, emphasizing its unique challenges to maternal and fetal health, particularly within the Canadian Gastroenterology setting. Seven key principles are highlighted: 1) Preconception counselling, aiming for steroid-free remission confirmed by objective markers, should be routine for female IBD patients. 2) Medication safety, with an eye to future pregnancies, should be addressed upon initiation. Methotrexate and small molecules are contraindicated during pregnancy, while most 5-ASA therapies, biologics, and thiopurines can be continued throughout pregnancy and breastfeeding. Steroids, though not without risks, can be utilized if necessary. 3) Routine monitoring during remission should include serum biomarkers and fecal calprotectin each trimester. 4) Routine endoscopy and imaging are not required, but if indicated, lower GI endoscopy, ultrasound, and unenhanced MRI can be used. Computed tomography and gadolinium enhanced MRI should be avoided. 5) Caesarean section is advised for patients with previous ileal pouch surgeries or active perianal disease, but other patients should follow obstetric indications for delivery. 6) Postpartum period may see more active disease, requiring continued monitoring. Breastfeeding is encouraged, and routine childhood vaccinations are advised, but live vaccinations in the first 6 months warrant detailed review. 7) Complex IBD patients may benefit from a multidisciplinary approach with robust communication between gastroenterologists and obstetricians.

Gut microbiome-associated predictors as biomarkers of response to advanced therapies in inflammatory bowel disease: a systematic review.

Loss of response to therapy in inflammatory bowel disease (IBD) has led to a surge in research focusing on precision medicine. Three systematic reviews have been published investigating the associations between gut microbiota and disease activity or IBD therapy. We performed a systematic review to investigate the microbiome predictors of response to advanced therapy in IBD. Unlike previous studies, our review focused on predictors of response to therapy; so the included studies assessed microbiome predictors before the proposed time of response or remission. We also provide an update of the available data on mycobiomes and viromes. We highlight key themes in the literature that may serve as future biomarkers of treatment response: the abundance of fecal SCFA-producing bacteria and opportunistic bacteria, metabolic pathways related to butyrate synthesis, and non-butyrate metabolomic predictors, including bile acids (BAs), amino acids, and lipids, as well as mycobiome predictors of response.

Preparation, Timing, Prokinetics, and Surface Agents in Video Capsule Endoscopy.

There is a trend in data to support active preparation for video capsule endoscopy (VCE), but the timing of this remains unclear. Split dosing may be the most efficacious preparation. Study methodology continues to evolve, with increased use of standardized scales, with the addition of diagnostic yield as an outcome. The use of adjuncts has not been detrimental, but their value has not been proved to improve outcomes of VCE.

Cystic fibrosis liver disease in Newfoundland and Labrador: a prevalence study.

Background: Liver disease in patients with cystic fibrosis (CF) is an understudied and increasingly common concern. The prevalence of cystic fibrosis liver disease (CFLD) in Canada has not been clearly established, although it is now the third leading cause of death among patients with CF. The current literature identifies a range in prevalence from 4% to 65%, which implies the need for further research. This study aimed to determine the prevalence of CFLD among adult patients with CF in Newfoundland and Labrador. Methods: Charts of patients with CF from the St. John's, Newfoundland, CF clinics were reviewed retrospectively for the presence of elevated liver enzymes, imaging or biopsy of the liver, and other etiologies of liver disease. Prevalence was determined for patients meeting the criteria for CFLD in the population as a whole and for those who had undergone all pertinent investigations. Results: The diagnostic guidelines for CFLD were met in 14 of 57 cases (24.6% prevalence). Severe CFLD was present in 9 patients (15.8%). Among all patients with CF, 33 (57.9%) had isolated liver enzyme elevation. Eleven patients had not had the requisite imaging performed for accurate diagnosis. Among the subset who had undergone imaging, the prevalence of CFLD was 30%. Conclusions: This study attempted to fill the gap in Canadian CFLD prevalence data by examining the population with CF in Newfoundland and Labrador. The prevalence of CFLD was found to be between 25% and 30%. More accurate determination of prevalence could be done with future cross-sectional or prospective studies.