Hannah Gordon, Livia Biancone, Gionata Fiorino, Konstantinos H Katsanos, Uri Kopylov, Eman Al Sulais, Jordan E Axelrad, Karthiha Balendran, Johan Burisch, Lissy

The leakage of the intestinal barrier and the disruption of the gut microbiome are increasingly recognized as key factors in different pathophysiological conditions, such as irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), chronic liver diseases, obesity, diabetes mellitus, types of cancer, and neuropsychiatric disorders. In this study, the mechanisms leading to dysbiosis and “leaky gut” are reviewed, and a short summary of the current knowledge regarding different diseases is provided. The simplest way to restore intestinal permeability and the microbiota could be ideal nutrition. Further therapeutic options are also available, such as the administration of probiotics or postbiotics or fecal microbiota transplantation.

Summary: Background: Some of the most important questions relating to the use of biological therapy in inflammatory bowel diseases concern the duration of maintenance therapy.Aim: To assess the disease course and frequency of relapse of Crohn's disease (CD) following discontinuation of biological therapy, and to determine predictive factors for relapse.Methods: One hundred twenty‐one CD patients who had achieved clinical remission following 1 year of biological therapy and for whom biological therapy was then discontinued participated in this prospective observational study. Eighty‐seven CD patients had received infliximab and 34 adalimumab. The definition of relapse was an increase of >100 points in CDAI to at least a CDAI of 150 points.Results: Biological therapy was restarted within 1 year of treatment cessation in 45% of patients. Logistic regression analysis revealed that previous biological therapy (P = 0.011) and dose intensification during the 1‐year course of biological therapy (P = 0.024) were associated with the need for and the time to the restarting of biological therapy. Smoking was observed to have an effect that was not statistically significant (P = 0.053).Conclusions: Biological therapy was restarted a median of 6 months after discontinuation in almost half of Crohn's disease patients in who had been in clinical remission following 1 year of biological therapy. These results suggest that, in the event of the presence of certain predictive factors, biological therapy should probably be continued for more than 1 year by most patients.

CT-P13 is the first biosimilar monoclonal antibody to infliximab (IFX); it has been approved for the same indications as its IFX counterpart in Hungary. The aim of this study was to assess the efficacy of CT-P13 induction therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC).

Introduction. CT-P13 is the first biosimilar to infliximab that was approved for the same indications as its originator infliximab. No data is available on the effect of infliximab biosimilar on mucosal healing. The aim of this study was to evaluate the efficacy of CT-P13 induction therapy on mucosal healing in patients with ulcerative colitis (UC). Patients and methods. UC patients, who received CT-P13 therapy from its local introduction at three Hungarian and one Czech IBD centres, were prospectively enrolled. Sigmoidoscopy was performed after the end of the induction therapy at week 14. Mucosal healing was defined as Mayo endoscopic subscore 0 or 1. Complete mucosal healing was defined as Mayo endoscopic subscore 0. Trough level of CT-P13 was measured at week 14. Results. Sixtythree UC patients who underwent CT-P13 induction therapy were enrolled in the study. Indication of the therapy was acute, severe flare up and chronic, refractory activity in 24 and 39 patients. Cumulative clinical response and steroid-free remission at week 14 were achieved in 82.5% and 47.6% of the patients. Sigmoidoscopy revealed steroid-free mucosal healing in 47.6% of the patients, complete mucosal healing was present in 27%. Mayo endoscopic subscore decreased significantly at week 14 compared to baseline. Trough levels of infliximab correlated with mucosal healing. Conclusion. This was the first study examining the efficacy of CT-P13 induction therapy on mucosal healing in UC. Our results indicate that mucosal healing is achieved in two thirds of UC patients by the end of the induction treatment with CT-P13.