Dysfunction of peripheral somatic and autonomic nervous system in patients with severe forms of Crohn's disease on biological therapy with TNFα inhibitors-A single center study.

OBJECTIVE: Crohn's disease (CD) can be associated with a wide range of extraintestinal manifestations (EIMs), including neurological ones. Published studies differ in their conclusions about the epidemiology and etiopathogenesis of neurological EIMs. The aims of this study were to demonstrate the presence and find risk factors of peripheral (somatic and autonomic) neuropathy patients with severe CD on anti-TNFα biological therapy. MATERIAL AND METHODS: A clinical examination focusing on detection of peripheral sensor-motor nervous dysfunction (including Sudoscan) and examination of autonomic nervous system dysfunction (using Ewing´s battery tests and spectral analysis) together with laboratory tests and collection of demographic data followed by administration of questionnaires were performed on a total of 30 neurologically asymptomatic outpatients with severe CD on anti-TNFα biological therapy. RESULTS: Peripheral sensor-motor nervous function via clinical neurological examination was pathological in 36.7% and Sudoscan in 33.3% of cases. Statistically significant associations between vibration perception test and age, CD and biological therapy duration, body mass index and Crohn's Disease Activity Index were proved while statistically significant associations between temperature perception test and age and BMI were proved as well. Additionally, a decrease of total protein in a patient´s serum below the physiological cut-off in the 6 months prior to measurement was associated with a pathological result of a Sudoscan. Cardiovascular autonomic neuropathy based on Ewing´s battery tests was present in 56.7% of patients, no statistically significant risk factors were found. Our peripheral neuropathy questionnaire correlated with the results of the Sudoscan test and some tests of the clinical examination of peripheral sensor-motor nervous function (discriminatory contact perception test, temperature perception test). CONCLUSIONS: This study demonstrated a relatively high prevalence of peripheral (especially autonomic) neuropathy and verified some risk factors for the development of peripheral somatic neuropathy in asymptomatic patients with severe form of CD on anti-TNFα biological therapy.

How to convince a patient refusing colonoscopy - a qualitative study.

The available literature suggests that the most significant barriers to undergoing colonoscopy in general include “fear of pain and discomfort”, “fear of bowel preparation”, as well as directly unrelated influences such as “lack of support from family and friends”, “busy family and work schedules”, “other health problems” and the current “fear of getting COVID-19 in hospital”. A marital union may play a positive role, previous cancer a negative one. Another important factor is that patients are not used to talking about their barriers spontaneously; a guided conversation is a useful tool. Respondents in this qualitative study addressed these barriers as significant in their answers.

Efficacy and safety of SARS-CoV-2 vaccination in patients with inflammatory bowel disease on immunosuppressive and biological therapy: Prospective observational study.

BACKGROUND AND AIMS: SARS-CoV-2 is a worldwide serious health problem and vaccination seems to have a crucial role in managing the COVID-19 pandemic. The aim of this prospective observational study was to monitor the trend of antibodies against SARS-CoV-2 after vaccination with BNT162b2 (COMIRNATY) in patients with inflammatory bowel disease treated by immunosuppressive and/or biological therapy, demonstrate whether any type of this therapy is associated with poorer production of antibodies against COVID-19 and evaluate the safety of vaccination against COVID-19 in these patients. METHODS: Eighty-seven eligible patients from one tertiary gastroenterological center with inflammatory bowel disease (60 with CD, 27 with UC) treated by immunosuppressive and/or biological therapy from the antiTNFα group were indicated to vaccination against SARS-CoV-2. Effectiveness of vaccination was evaluated by the values of antibodies before and 4 weeks after 2nd dose of vaccine. Additional goal was to evaluate adverse events of vaccination. RESULTS: Before the 2nd dose of vaccine, geometric mean of SARS-CoV-2 IgG antibodies were 40.7 U/ml in the biological therapy group, 34.8 U/ml in the azathioprine group and 44.8 U/ml in the combination therapy group of patients. The geometric means were 676.5.7 U/ml in the biological therapy group, 614.4 U/ml in the azathioprine group and 500.1 U/ml in the combination therapy group of patients four weeks after 2nd dose. Statistically significant differences between these groups were not proved. Several non-severe local and general adverse events were present in our patients with a majority of these events on the day of vaccine administration and the day after, no anaphylactic reactions were present. CONCLUSIONS: Our measurements proved the efficacy and safety of vaccination against SARS-CoV-2 in patients with inflammatory bowel disease treated by immunosuppressive and/or biological therapy. Statistically significant differences between our groups of patients were not proved.

Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring.

OBJECTIVE: The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab. MATERIAL AND METHODS: Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn's disease (CD) or ulcerative colitis (UC). Effectiveness of therapy was evaluated via the Crohn's Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy. RESULTS: In CD patients, remission (CDAI <150) was achieved in 73.5% of cases, partial response (≥70-point decrease in CDAI score from baseline) in 11.8%, no response in 11.8% and 2.9% patients discontinued therapy. In UC patients, remission (total score on partial Mayo index ≤2 points) was achieved only in 18.8% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 43.8%, no response in 25.0% and 12.5% patients discontinued therapy. There were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin and CRP serum levels after 12 weeks of therapy. Seven adverse events were identified, three of which resulted in therapy being discontinued. CONCLUSIONS: This prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD.

Weight loss in conservative treatment of obesity in women is associated with physical activity and circadian phenotype: a longitudinal observational study.

INTRODUCTION: The study investigates the association between circadian phenotype (CP), its stability (interdaily stability - IS) and physical activity (PA) in a weight loss (WL) programme. METHODS: Seventy-five women in WL conservative treatment (BMI ≥ 25 kg/m2) were measured (for about 3 months in between 2016 and 2018) by actigraphy. RESULTS: We observed a difference in time of acrophase (p = 0.049), but no difference in IS (p = 0.533) between women who lost and did not lose weight. There was a difference in PA (mesor) between groups of women who lost weight compared to those who gained weight (p = 0.007). There was a relationship between IS and PA parametres mesor: p0.001; and the most active 10 h of a day (M10): p < 0.001 - the more stable were women in their rhythm, the more PA they have. Besides confirming a relationship between PA and WL, we also found a relation between WL and CP based on acrophase. Although no direct relationship was found for the indicators of rhythm stability (IS), they can be considered very important variables because of their close connection to PA - a main factor that contributes to the success of the WL programme. DISCUSSION: According to the results of the study, screening of the CP and its stability may be beneficial in the creation of an individualized WL plan.

Sexual Dysfunctions in Obese Women Before and After Bariatric Surgery.

BACKGROUND Obesity and associated comorbidities increase the probability of sexual disorders. The present study evaluated sexual satisfaction levels in obese women prior to and following bariatric surgery, utilizing the validated Female Sexual Function Index (FSFI) to also evaluate the sexual satisfaction in obese and non-obese women. MATERIAL AND METHODS 60 obese women (mean initial BMI of 43.7±5.9 kg/m²; mean age of 41.7±10.8 years) were administered the questionnaire on sexual function (FSFI) preceding bariatric surgery (laparoscopic adjustable gastric banding, 22 women; gastric plication, 33 women; and biliopancreatic diversion, 5 women), 6 months and 12 months after the procedure, i.e., following substantial weight reduction (final mean BMI of 35.5±5.5 kg/m²). The control group comprised 60 non-obese women (mean BMI of 22.2±1.9kg/m²; mean age of 36.4±10.7 years). RESULTS Our findings indicate that baseline sexual function in the preoperative obese females was significantly lower than in non-obese women, with p<0.01 in each domain. Data gathered at the 6- and 12-month points following the procedure indicated no significant difference. Before the procedure, 31 obese subjects (51.6%) exceeded the cutoff for FSD, at the 6-month evaluation point, 17 women (39.5%) exceeded the cutoff, and at 12 months postoperatively, 18 subjects (41.9%) exceeded the cutoff, indicative of FSD. Among the non-obese controls, only 9 subjects (15%) exceeded the cutoff threshold. CONCLUSIONS These findings show that substantive weight reduction resulting from bariatric surgery results in reduced sexual dysfunction in female subjects.

Splitting, impulsivity, and intimate partnerships in young obese women seeking bariatric treatment.

BACKGROUND: Splitting represents a defense mechanism that describes fragmentation of conscious experience that may occur in various psychopathological conditions. The purpose of this study was to examine the relationship of splitting with disturbed cognitive and affective functions related to impulsivity and intimate partnerships in a group of obese patients indicated for bariatric treatment and compare the results with other obese patients and patients with bulimia nervosa. METHODS: In this clinical study, we assessed 102 young women. The sample was divided into three subgroups: obese women (N=30), obese women indicated for bariatric treatment (N=48), and patients with bulimia nervosa (N=24). The patients were assessed using Splitting Index and Barratt Impulsivity Scale, and selected information about their intimate partnership was documented for all the participants. RESULTS: The main results of this study indicate significant differences in the relationship of splitting and impulsivity with difficulties in intimate partnerships. These differences discriminate obese patients indicated for bariatric treatment from other obese patients and patients with bulimia nervosa. CONCLUSION: These findings may have significant implications for treatment of the obese patients indicated for bariatric treatment and their presurgery psychological evaluations.