Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn's disease: results from a large Italian cohort study.

OBJECTIVE: Ustekinumab (UST) is an anti-IL12/23 antibody for the treatment of Crohn's Disease (CD). The aim of this study was to compare the efficacy and safety of UST in a large population-based cohort of CD patients who failed previous treatment with other biologics. PATIENTS AND METHODS: 194 CD patients (108 males and 86 females, mean age 48 years (range 38-58 years) were retrospectively reviewed. 147 patients were already treated with anti-TNFα (75.8%), and 47 (24.2%) patients were already treated with anti-TNFα and vedolizumab. Concomitant treatment with steroids was present in 177 (91.2%) patients. RESULTS: At week 12, clinical remission was achieved in 146 (75.2%) patients. After a mean follow-up of 6 months, clinical remission was maintained in 135 (69.6%) patients; at that time, mucosal healing was assessed in 62 (31.9%) patients, and it was achieved in 33 (53.2) patients. Three (1.5%) patients were submitted to surgery. Steroid-free remission was achieved in 115 (59.3%) patients. Both serum C-Reactive Protein and Fecal Calprotectin (FC) levels were significantly reduced with respect to baseline levels during follow-up. A logistic regression, UST therapy as third-line therapy (after both anti-TNFα and vedolizumab), FC >200 µg/g, and HBI ≥8 were significantly associated with lack of remission. Adverse events occurred in 5 (2.6%) patients, and four of them required suspension of treatment. CONCLUSIONS: UST seemed to be really effective and safe in CD patients unresponsive to other biologic treatments, especially when used as second-line treatment.

[Partially hydrolyzed guar gum: a fiber as coadjuvant in the irritable colon syndrome]. / Gomma guar parzialmente idrolizzata: una fibra come coadiuvante nella sindrome del colon irritabile.

PURPOSE: Partially hydrolyzed guar gum (PHGG) is a water-soluble dietary fiber, possessing non-gelling properties. The objective of this clinical experience was to evaluate the progress of symptoms and the modifications in the frequency of evacuation in subjects affected by IBS and regularly taking PHGG. PATIENTS AND METHODS: The group was made up of 134 out-patients of both sexes, average age 43.12, suffering from IBS, both obese and of normal weigh, with a mean number of weekly evacuations between 2 and 35. The subjects, divided in 2 groups on the basis of Body Mass Index (BMI), were submitted for 24 weeks to a balanced, low or normal calorie diet supplemented by 5 g a day of PHGG. The following information was gathered: number of weekly evacuation, typical symptoms of IBS, cholesterol, triglycerides and glucose levels. In a few subjects (n. = 34) also the plasmatic electrolyte levels, before and during PHGG intake, were evaluated. RESULTS: Both groups showed positive results in the evacuation frequency (p < 0.01 at 12th week) and a decrease, after 3 weeks of PHGG intake, in frequency of IBS symptoms such as flatulence (-55.6%), abdominal tension (-4.7%) and abdominal spasm (-35%). On the other hand an increased number of subjects showed normal levels of cholesterol (+12.2%), lipids (+26.9%) and glucose (+16%). Concentrations of plasmatic electrolytes didn't change during PHGG intake, except for a marked increase of selenium levels, compared to pre-intake levels. CONCLUSIONS: The observations obtained from this clinical experience reassert that dietary fiber supplementation is useful in cases of altered intestinal motility. PHGG, due to its water-solubility and non-gelling properties, can be useful also in IBS.

Gastrospirillum Hominis associated chronic active gastritis: the first report from Italy.

Recently a spiral bacterium different from Helicobacter Pylori (HP) was observed in the human stomach and the name of Gastrospirillum Hominis (GH) was proposed for this organism. GH presence is reported to be not associated to HP but related to chronic active gastritis. We describe the case of a 31 year old male suffering from upper abdominal symptoms, who underwent oesophagogastroduodenoscopy, which revealed a picture of duodenal hyperemia. Gastric body showed a normal mucosa and absence of HP, while active chronic gastritis associated with HP was found in the antrum. In addition few spiral bacteria showing 4-5 spirals, larger than HP were observed within the gastric crypts and beneath the mucus layer in this site. This case represents the first report from our geographic area (Southern Italy) of the possibility of finding bacteria different from HP in the human stomach. The simultaneous HP presence does not allow us to relate the chronic active gastritis of the patient with the GH like bacteria. Our finding, however, suggests the possibility that HP and GH may be simultaneously present in the course of type B antral chronic inflammation. This association was not observed in previous investigations.