ABSTRACT
Inflammatory bowels diseases (IBD) are high risk conditions for colorectal cancer (CRC). The discovery of IBD and CRC noninvasive protein/peptide biomarkers using saliva and feces was the aim of this study involving 20 controls, 25 IBD (12 Crohn's Disease-CD), 37 CRC. By untargeted proteomic (LTQ-Orbitrap/MS), a total of 152 proteins were identified in saliva. Absent in controls, 73 proteins were present in both IBD and CRC, being mainly related to cell-adhesion, cadherin-binding and enzyme activity regulation (g-Profiler). Among the remaining 79 proteins, 14 were highly expressed in CD and 11 in CRC. These proteins clustered in DNA replication/expression and innate/adaptive immunity. In stool, endogenous peptides from 30 different proteins were identified, two being salivary and CD-associated: Basic Proline-rich Protein 1 (PRBs) and Acidic Proline-rich Phosphoprotein. Biological effects of the PRBs-related peptides GQ-15 and GG-17 found in CD stool were evaluated using CRC cell lines. These peptides induced cell proliferation and activated Erk1/2, Akt and p38 pathways. In conclusion, the salivary proteome unveiled DNA stability and immunity clusters shared between IBD and CRC. Salivary PRB-derived peptides, enriched in CD stool, stimulate CRC cell proliferation and the pro-oncogenic RAS/RAF/MEK/ERK and PI3K/AKT/mTOR pathways suggesting a potential involvement of PRBs in IBD and cancer pathogenesis.
Subject(s)
Colorectal Neoplasms , Proteomics , Saliva , Humans , Colorectal Neoplasms/metabolism , Proteomics/methods , Male , Female , Saliva/metabolism , Middle Aged , Adult , Inflammatory Bowel Diseases/metabolism , Inflammatory Bowel Diseases/pathology , Aged , Proteome/metabolism , Proteome/analysis , Feces/chemistry , Biomarkers, Tumor/metabolism , Cell Line, TumorABSTRACT
Background: Inflammatory bowel diseases (IBDs) have a peak incidence between the second and fourth decades of life and can affect women's reproductive life. Objectives: Our study aimed to assess the impact of IBD on the reproductive life of female patients with this condition. Design: Cross-sectional study. Methods: Women with IBD followed at our IBD Unit and a group of healthy controls were enrolled. Data on reproductive life were collected using a dedicated questionnaire. Results: The study included 457 women, of whom 228 had IBD, and 229 age-matched healthy controls. No differences were found in the use of contraceptives, infertility, and endometriosis. The risk of spontaneous and voluntary abortions was significantly higher in IBD patients than in healthy controls [odds ratio (OR) 2 and 3.62, respectively]. The risk of obstetrical complications in the IBD population was more than six times higher in patients who experienced disease reactivations during pregnancy than in those with persistent remission [OR 6.9, 95% confidence interval (CI) 1.51-31.28]. Finally, we found that the chances of breastfeeding were 66% lower in patients with IBD than in controls (OR 0.44, 95% CI 0.22-0.91). Conclusion: Our study underlines the negative impact of IBD on women's reproductive life, supporting the need for proactive preconception counseling.
Reproductive life in IBD women Summarise the established knowledge on this subject Most women with Inflammatory Bowel Diseases are affected during their reproductive years.Women with IBD have fear, uncertainty, and poor knowledge of how the disease can impact their reproductive life. What are the significant and/or new findings of this study?Higher prevalence of abortions in women with IBD.Confirmed adverse pregnancy outcomes in the case of IBD activity.A lower chance of breastfeeding in women with IBD.Pro-active counselling is needed, which start from the moment of conception choice, with correct management of the pathology.
ABSTRACT
The gastrointestinal tract is home to trillions of diverse microorganisms collectively known as the gut microbiota, which play a pivotal role in breaking down undigested foods, such as dietary fibers. Through the fermentation of these food components, short-chain fatty acids (SCFAs) such as acetate, propionate, and butyrate are produced, offering numerous health benefits to the host. The production and absorption of these SCFAs occur through various mechanisms within the human intestine, contingent upon the types of dietary fibers reaching the gut and the specific microorganisms engaged in fermentation. Medical literature extensively documents the supplementation of SCFAs, particularly butyrate, in the treatment of gastrointestinal, metabolic, cardiovascular, and gut-brain-related disorders. This review seeks to provide an overview of the dynamics involved in the production and absorption of acetate, propionate, and butyrate within the human gut. Additionally, it will focus on the pivotal roles these SCFAs play in promoting gastrointestinal and metabolic health, as well as their current therapeutic implications.
ABSTRACT
BACKGROUND: The administration of biological drugs in inflammatory bowel diseases (IBD) is increasingly moving from intravenous to subcutaneous formulations. AIMS: To evaluate the efficacy and safety of vedolizumab subcutaneous administration after switching from intravenous administration in ulcerative colitis (UC) patients in corticosteroid-free clinical remission. METHODS: An observational, multicentre, prospective study was conducted by the Italian Group for the study of IBD (IG-IBD). UC patients in clinical remission (pMAYO < 2) not receiving steroids for > 8 months before the switch, and with at least 6 months of follow-up were included. Switch from intravenous to subcutaneous vedolizumab was defined as successful in patients not experiencing a disease flare (pMAYO ≥ 2) or needing oral steroids or stopping subcutaneous vedolizumab during the 6 months of follow-up after the switch. RESULTS: Overall, 168 patients were included. The switch was a success in 134 patients (79.8%). Vedolizumab retention rate was 88.7% at month six. C-reactive protein and faecal calprotectin values did not change after the switch (p = 0.07 and p = 0.28, respectively). Ten of the 19 patients who stopped subcutaneous formulation switched back to intravenous formulation recapturing clinical remission in 80%. Side effects were observed in 22 patients (13.1%). CONCLUSION: Effectiveness of switching from intravenous to subcutaneous vedolizumab formulation in UC patients in steroid-free clinical remission is confirmed in a real-world setting.
Subject(s)
Colitis, Ulcerative , Inflammatory Bowel Diseases , Humans , Administration, Intravenous , Colitis, Ulcerative/drug therapy , Gastrointestinal Agents , Inflammatory Bowel Diseases/drug therapy , Prospective Studies , Steroids/therapeutic use , Treatment OutcomeABSTRACT
Most adverse reactions to food are patient self-reported and not based on validated tests but nevertheless lead to dietary restrictions, with patients believing that these restrictions will improve their symptoms and quality of life. We aimed to clarify the myths and reality of common food intolerances, giving clinicians a guide on diagnosing and treating these cases. We performed a narrative review of the latest evidence on the widespread food intolerances reported by our patients, giving indications on the clinical presentations, possible tests, and dietary suggestions, and underlining the myths and reality. While lactose intolerance and hereditary fructose intolerance are based on well-defined mechanisms and have validated diagnostic tests, non-coeliac gluten sensitivity and fermentable oligosaccharide, disaccharide, monosaccharide, and polyol (FODMAP) intolerance are mainly based on patients' reports. Others, like non-hereditary fructose, sorbitol, and histamine intolerance, still need more evidence and often cause unnecessary dietary restrictions. Finally, the main outcome of the present review is that the medical community should work to reduce the spread of unvalidated tests, the leading cause of the problematic management of our patients.
Subject(s)
Food Hypersensitivity , Lactose Intolerance , Humans , Food Intolerance/complications , Food Hypersensitivity/diagnosis , Food Hypersensitivity/etiology , Quality of Life , Lactose Intolerance/diagnosis , Lactose Intolerance/complications , DietABSTRACT
Eosinophilic esophagitis (EoE) is a chronic esophageal disease that needs lifelong management and follow-up. The diagnosis requires an upper endoscopy with at least one esophageal biopsy demonstrating >15 eosinophils/high-power field, and often occurs with a diagnostic delay of up to ten years, partly due to the absence of valid non-invasive screening tools. In addition, serial upper endoscopies with esophageal biopsies are mandatory to assess the efficacy of any ongoing treatment in patients with EoE. These procedures are invasive, costly, and, when performed without sedation, are often poorly tolerated by patients. Therefore, there is the clinical need to identify reliable non-invasive or minimally invasive biomarkers that could be used to assess disease activity in clinical practice as a surrogate of peak eosinophil counts on esophageal biopsies. This review summarizes evidence on investigational non-invasive or minimally invasive biomarkers for the diagnosis and follow-up of EoE to report on the state of the art in the field and support future research. We discussed eosinophil-derived mediators including eosinophil cationic protein (ECP), eosinophil-derived neurotoxin (EDN, also known as eosinophil protein X), eosinophil peroxidase (EPO), and major basic protein (MBP) as well as other promising non-eosinophil-derived biomarkers. Although several studies have shown the utility of most biomarkers collected from the serum, esophageal luminal secretions, and feces of EoE patients, numerous limitations currently hamper the integration of such biomarkers in clinical practice. Future studies should aim at validating the utility of non-invasive and minimally invasive biomarkers using rigorous protocols and updated consensus criteria for EoE.
ABSTRACT
The gluten-free diet [GFD] has been linked to an increased risk of weight gain and the development of metabolic disorders. Most of the studies have focused on the effect of GFD on the Body Mass Index [BMI]. We aimed to evaluate the nutritional status using specific nutritional parameters in patients with celiac disease [CeD] at diagnosis and on a GFD compared to healthy controls. We recruited subjects at our outpatient clinic at the University of Padua. We collected demographic and clinical data and values obtained with bioelectrical impedance analysis. A total of 24 CeD patients and 28 healthy controls were enrolled. CeD patients at diagnosis had a lower body cell mass index [BCMI, p = 0.006], fat-free mass index [FFMI, p = 0.02], appendicular skeletal muscle index [ASMI, p = 0.02], and phase angle [PA] [p < 0.001] compared to controls. Their percentage of extracellular water [ECW] was also higher [p < 0.001]. Considering CeD patients after GFD, nutritional status significantly improved after 6 months of GFD. We did not observe differences in BMI among groups [p = ns]. CeD patients at diagnosis were found to have a poorer nutritional status than healthy controls, with a positive effect of the GFD on their nutritional status, underlining the inefficacy of evaluating this aspect through only BMI evaluation.
Subject(s)
Celiac Disease , Nutritional Status , Humans , Adult , Electric Impedance , Prospective Studies , Body Mass Index , Weight Loss , Diet, Gluten-Free/adverse effectsABSTRACT
BACKGROUND: Oncostatin M was recently highlighted as a promising biomarker for therapeutic effectiveness in inflammatory bowel diseases (IBD), with particular regard for infliximab. The primary aim was to evaluate the ability of serum oncostatin M to predict endoscopic response to different drugs in IBD. METHODS: We selected two different cohorts of patients with IBD, treated with anti-TNF (infliximab and adalimumab) or with vedolizumab. Therapeutic response was evaluated at week 54 in terms of mucosal healing. Serum oncostatin M and C-reactive protein were measured at baseline; fecal calprotectin was measured at baseline and after 14 weeks of treatment. We evaluated the association of these biomarkers with mucosal healing at week 54. RESULTS: Among 66 patients treated with anti-TNFs and 68 treated with vedolizumab, 35 and 31 attained mucosal healing, respectively. Mucosal healing at 54 weeks was significantly associated with low oncostatin M levels at baseline in the anti-TNF cohort; the diagnostic accuracy of oncostatin M at baseline in predicting mucosal healing was 0.91 (95% CI 0.84 to 0.99) in the anti-TNF cohort and 0.56 (95% CI 0.43 to 0.70, P < 0.001) in the vedolizumab cohort. Mucosal healing was also associated with low fecal calprotectin levels at week 14 in both cohorts. CONCLUSION: Our study suggests that serum oncostatin M is a drug-specific biomarker, since it could be used to predict therapeutic effectiveness to anti-TNFs but not to vedolizumab. Moreover, these results emphasize the utility of serum oncostatin M measurement in patients treated with anti-TNF.
Subject(s)
Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Adalimumab/therapeutic use , Biomarkers , C-Reactive Protein , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Humans , Inflammatory Bowel Diseases/drug therapy , Infliximab/therapeutic use , Leukocyte L1 Antigen Complex , Oncostatin M/therapeutic use , Treatment Outcome , Tumor Necrosis Factor InhibitorsABSTRACT
During the coronavirus disease 2019 (COVID-19) pandemic, immunomodulatory therapies and hospital admission were suspected to increase the risk of infection. Nevertheless, patients with inflammatory bowel diseases (IBD) treated with intravenous (i.v.) biologics had to move to hospitals for drug infusion. We investigated the impact of hospitalisation in patients with IBD. We conducted a survey including consecutive IBD patients initially in clinical and biochemical remission treated with biologics at the end of the first lockdown period. Patients underwent the normally scheduled clinical visits, performed at hospital for i.v.-treated patients or at home for patients treated with s.c. drugs. We administered to all patients the Hospital Anxiety and Depression Scale (HADS) questionnaire and other 12 questions, specifically related to COVID-19 and its implications. A total of 189 IBD patients were recruited, 112 (59.3%) treated with i.v. drugs and 77 (40.7%) with s.c. ones. No relapses were recorded in either group (hospitalized vs. non-hospitalized, p = ns), as well as which, COVID-19 infections were not demonstrated in patients in contact with people with suspected symptoms or directly experiencing them. The total HADS score obtained by the sum of all items was also almost identical between groups (37.1 ± 2.8 vs. 37.2 ± 2.8; p = 0.98). In patients treated with i.v. drugs receiving a televisit (n = 17), the rate of satisfaction with telemedicine (58.8%) was significantly lower compared with those treated with s.c. drugs (94.8%; p < 0.0005). Our results suggest that hospitalisation during the COVID-19 outbreak does not increase the risk of COVID-19 infection as well as the risk of IBD relapse; moreover, the similar levels of anxiety in both groups could confirm that there is no need to convert patients from i.v. to s.c. therapy.
ABSTRACT
BACKGROUND: Head-to-head comparison studies evaluating the effectiveness and tolerability of anti-tumor necrosis factor (anti-TNF) drugs in inflammatory bowel disease patients are lacking. AIM: To compare the effectiveness and tolerability of anti-TNF-α drugs used in clinical practice in a cohort of patients with moderate-to-severe ulcerative colitis (UC). METHODS: Retrospectively, 122 UC patients treated with infliximab (IFX) originator and biosimilar, adalimumab (ADA), and golimumab (GOL) were included. We performed an ITT analysis to evaluate clinical response and remission, steroid-free clinical remission, and endoscopy response according to the different time points of the follow-up. Baseline and post induction predictor factors of these outcomes were evaluated using multivariate logistic regression models. Moreover, a propensity score-based weighting analysis was performed. Data were analyzed using R and STATA11 software. RESULTS: The overall clinical response was 77% after induction, 81.4% at 30 weeks, and 76.9% at 52 weeks, while the steroid-free clinical remission was 39.7, 46, and 54.6%, respectively. After induction, a higher rate of treatment failure was observed in the GOL group. At the end of follow-up, lower rates of steroid-free clinical remission and clinical response were obtained by GOL. At week 52, endoscopic response was achieved by 46.5% of the population. CONCLUSIONS: Among the different anti-TNF treatments, moderate-to-severe UC seems to respond better to IFX and ADA, whereas GOL seems to be less effective, despite a similar good safety profile.
Subject(s)
Biological Products/therapeutic use , Colitis, Ulcerative/drug therapy , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adalimumab/therapeutic use , Adult , Antibodies, Monoclonal/therapeutic use , Biosimilar Pharmaceuticals/therapeutic use , C-Reactive Protein/metabolism , Female , Humans , Infliximab/therapeutic use , Male , Probability , Propensity Score , Retrospective Studies , Treatment OutcomeABSTRACT
BACKGROUND AND AIM: Autoimmune atrophic gastritis (AAG) is characterized by a variable spectrum of gastric and extra-gastric symptoms and has been associated with other autoimmune diseases. It is still unknown whether AAG patients have a higher risk of coeliac disease (CeD) or of any other particular duodenal histological damage. Our study aimed at evaluating the duodenal histological findings and the risk of CeD in patients with AAG, with and without other concurrent autoimmune diseases. METHODS: We retrospectively collected all the histological findings of the adult patients undergoing upper gastrointestinal endoscopy with concurrent duodenal and gastric biopsies at our gastroenterology unit between 2015 and 2018 and who were regularly followed up at our centre. Date of endoscopy evaluation, endoscopy indication, data on previous CeD diagnosis and on other autoimmune-associated diseases, and a description of histological diagnosis were recorded. RESULTS: Of the 2,423 evaluated endoscopies, 209 patients had an AAG diagnosis (8.6%). One hundred thirty-nine patients, aged 57.4 (standard deviation 13.2) years, were regularly followed up at our centre and were included. Of them, 4 subjects had a previous diagnosis of CeD and one had CeD diagnosis at index endoscopy. Additionally, 8 patients had an isolated increase of intraepithelial lymphocytes (IELs, 6%) and 2 villous atrophy with a normal IEL count. The risk of CeD in AAG was not modulated by the presence of other concurrent autoimmune diseases. CONCLUSIONS: We support the screening of all AAG patients with CeD autoantibodies. Findings of isolated IEL or villous atrophy are not exclusively related to CeD.
Subject(s)
Celiac Disease , Gastritis, Atrophic , Adult , Atrophy/pathology , Celiac Disease/complications , Celiac Disease/epidemiology , Celiac Disease/pathology , Duodenum/pathology , Gastritis, Atrophic/complications , Gastritis, Atrophic/epidemiology , Gastritis, Atrophic/pathology , Humans , Retrospective StudiesABSTRACT
BACKGROUND: Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response. OBJECTIVE: This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis. METHODS: Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy. RESULTS: A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range: 4-142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio [OR] = 3.02, 95% confidence interval [CI]: 1.44-6.29; p = 0.003) and being able to discontinue steroids at Week 8 (OR = 3.32, 95% CI: 1.34-8.30; p = 0.010) and Week 14 (OR = 2.94, 95% CI: 1.08-8.02; p = 0.036) were associated with longer persistence on therapy. At Week 54, 65/124 (52.4%) postinduction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy (p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients. CONCLUSIONS: Biological-naïve status and not requiring steroids at Weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.
Subject(s)
Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal/therapeutic use , Colitis, Ulcerative/drug therapy , Gastrointestinal Agents/adverse effects , Gastrointestinal Agents/therapeutic use , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Adolescent , Adult , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Retrospective Studies , Young AdultABSTRACT
The treatment for coeliac disease (CD) has a considerable psychological impact on patients, which may vary depending on subjects and clinical characteristics. The aim of this study was to describe the quality of life (QoL) in CD patients during follow-up, evaluating which factors can influence it. Patients with CD who consecutively visited the outpatient clinic of CD Unit of the University Hospital of Padua from January to September 2019 were enrolled. Demographics and clinical information were collected, and all patients were asked to answer the CD-QoL and Biagi's validated questionnaires. Student's t-test and chi-square test were used to compare the continuous and categorical variables, respectively. One hundred patients were enrolled (86 females, mean age at test ± SD: 39.73 ± 13.51; mean age at diagnosis ± SD: 33.09 ± 12.92), with 61% of them having been diagnosed with CD within the previous 5 years. At the time of diagnosis, 43 CD patients reported classical CD presentation, 32 non-classical features, 16 only anaemia and 9 were asymptomatic. The mean CD-QoL value was overall high (80.54 ± 11.91). We found that the "health concerns" subscale score was significantly lower in subjects aged more than 35 years compared to younger subjects (p = 0.03). We also observed that the CD-QoL score in gluten-free diet (GFD)-adherent patients tended to be higher compared to subjects who were non-compliant, with a significantly higher percentage of patients with low score for the "dysphoria" subscale (p = 0.05). This study showed an overall good QoL in subjects on a GFD. However, subjects older and non-compliant to GFD appear to experience more health concerns and suffer from dysphoria, respectively.
Subject(s)
Celiac Disease/psychology , Diet, Gluten-Free/psychology , Patient Compliance/psychology , Quality of Life , Adult , Celiac Disease/diet therapy , Depression/etiology , Female , Humans , Male , Middle Aged , Surveys and QuestionnairesABSTRACT
Eosinophilic gastrointestinal diseases (EGIDs) are chronic gastrointestinal conditions requiring corticosteroid and immunosuppressive therapy for disease control. Patients with EGIDs usually report impaired quality of life. We aimed to report the clinical and psychological impact of COVID-19 infection in EGID patients. In this prospective web-based study we invited all consecutive EGID patients attending the University Hospital of Salerno (Campania) and Padua (Veneto) to fill an ad hoc COVID-19 survey. Moreover, a telemedicine service for direct consultation was organized. Data regarding the occurrence and perception of COVID-19 infection as well as clinical information were recorded. The study population included 102 EGID patients (mean age 36.6 years, 34 females), of whom 89 had eosinophilic esophagitis, nine had gastroenteritis, and four had colitis. No patient was diagnosed with COVID-19 or had recurrence of his/her primary disease. All of them were adherent to therapy and preventive measures adoption. Most patients were worried because of COVID-19 and social preventing measures but did not consider themselves at major risk or susceptible to COVID-19 or other infections due to their chronic condition or therapy. Female gender and low education level were associated to a higher psychological perception of COVID-19 compared to lockdown status or other demographic and clinical factors (p < 0.05). Overall, COVID-19 had a limited clinical impact on patients with EGIDs. The degree of education and sex, but not the fact of living in a lockdown area, influenced the perception of SARS-CoV-2 infection.
Subject(s)
Coronavirus Infections/epidemiology , Eosinophilia/epidemiology , Gastrointestinal Diseases/epidemiology , Pneumonia, Viral/epidemiology , Adolescent , Adrenal Cortex Hormones/therapeutic use , Adult , Aged , Aged, 80 and over , Betacoronavirus , Body Mass Index , COVID-19 , Case-Control Studies , Child , Coronavirus Infections/physiopathology , Diet, Gluten-Free , Eosinophilia/drug therapy , Female , Gastrointestinal Diseases/drug therapy , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/physiopathology , Prospective Studies , Proton Pump Inhibitors/therapeutic use , SARS-CoV-2 , Young AdultABSTRACT
BACKGROUND: Data on vedolizumab (VDZ) use in inflammatory bowel disease (IBD) patients are still limited. We aimed to assess the effectiveness and tolerability of VDZ in a real-life clinical scenario. METHODS: We retrospectively collected data of all consecutive IBD patients who started VDZ from September 2016 to December 2018 at our IBD Unit of the University Hospital of Padua and strictly followed them for 1 year. Clinical benefit (rate of clinical steroid-free remission plus clinical response), endoscopic and histological responses were evaluated over 1 year. RESULTS: A total of 117 patients who started VDZ for Crohn's disease (CD) and ulcerative colitis (UC) were included in the main analysis (69 CD patients, 48 UC patients). We obtained a clinical benefit in 68.1%, 68.1% and 59.4% of CD patients and in 68.7%, 54.2% and 54.1% of UC patients after induction, and at 30 weeks and 52 weeks, respectively. After 1 year, endoscopy response was observed in 47% of CD and 38.2% of UC patients, while the histological response was 19.6% and 23.5%, respectively. Finally, we found that 20.5% of patients needed treatment optimization, with 33.3% of them failing to respond despite this action. No deaths or serious adverse events requiring hospitalization were observed. The main cause of VDZ interruption was drug inefficacy. During the study, two patients developed new spondylarthritis, and two had a worsening of pre-existing arthralgia. CONCLUSION: Vedolizumab resulted in being effective and safe in CD as well as in UC patients.
Subject(s)
Ambulatory Care/methods , Esophageal pH Monitoring/methods , Gastrointestinal Diseases/diagnosis , Manometry/methods , Personal Protective Equipment , Personnel Staffing and Scheduling , Telemedicine/methods , Betacoronavirus , Biofeedback, Psychology , Breath Tests , COVID-19 , Coronavirus Infections/epidemiology , Disease Management , Gastroenterology , Gastrointestinal Diseases/therapy , Hospital Units , Humans , Pandemics , Pelvic Floor , Pneumonia, Viral/epidemiology , Practice Guidelines as Topic , SARS-CoV-2ABSTRACT
INTRODUCTION: There are no real-life studies comparing the efficacy and safety of the different antitumor necrosis factor (TNF)-α drugs available in patients with ulcerative colitis (UC) and Crohn's disease (CD). To verify the effectiveness and tolerability of different anti-TNF-α agents (infliximab [IFX] originator, biosimilar CTP13, and adalimumab [ADA]) in patients with moderate-to-severe CD and UC. METHODS: Retrospectively, patients with moderate-to-severe inflammatory bowel disease who completed induction with either ADA, IFX originator, or biosimilar from 2015 to 2017 were included. Patients were evaluated after induction at 30 and 52 weeks. We performed an intention-to-treat analysis to evaluate clinical response and remission, steroid-free clinical remission, and endoscopy response according to different time points. At every time point, the need for dose escalation and occurrence of adverse events have been reported. RESULTS: Eighty-nine patients with UC (31 ADA, 30 IFX originator, and 28 IFX biosimilar) and 90 patients with CD (30 for each drug groups) were enrolled. After induction at week 30 and 52, clinical response was obtained by the following: 84.3%, 86.5%, and 82% of UC and 93.3%, 88.9%, and 80% of CD. Clinical steroid-free remission rates were significantly higher in the CD group compared with the UC group at every time point (P < 0.05). At week 52, 31.1% of ADA, 16.7% of IFX originator, and 36.2% of biosimilar patients needed treatment optimization. At week 52, 13 patients had suspended therapy because of severe adverse events, including 3 cases of malignant disease. DISCUSSION: Anti-TNF-α treatment was more effective in patients with CD compared to patients with UC, independently of the drug used.
Subject(s)
Biological Products/administration & dosage , Colitis, Ulcerative/drug therapy , Crohn Disease/drug therapy , Gastrointestinal Agents/administration & dosage , Adalimumab/administration & dosage , Adalimumab/adverse effects , Adolescent , Adult , Aged , Aged, 80 and over , Biological Products/adverse effects , Biosimilar Pharmaceuticals/administration & dosage , Biosimilar Pharmaceuticals/adverse effects , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/immunology , Colon/diagnostic imaging , Colon/drug effects , Colon/immunology , Colonoscopy , Crohn Disease/diagnosis , Crohn Disease/immunology , Female , Gastrointestinal Agents/adverse effects , Humans , Ileum/diagnostic imaging , Ileum/drug effects , Ileum/immunology , Infliximab/administration & dosage , Infliximab/adverse effects , Intestinal Mucosa/diagnostic imaging , Intestinal Mucosa/drug effects , Intestinal Mucosa/immunology , Male , Middle Aged , Remission Induction/methods , Retrospective Studies , Severity of Illness Index , Treatment Outcome , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Tumor Necrosis Factor-alpha/immunology , Young AdultABSTRACT
BACKGROUND: Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. We investigated the effect of a colonic-delivery formulation of butyrate on the fecal microbiota of patients with inflammatory bowel diseases (IBDs). METHODS: In this double-blind, placebo-controlled, pilot study, 49 IBD patients (n = 19 Crohn's disease, CD and n = 30 ulcerative colitis, UC) were randomized to oral administration of microencapsulated-sodium-butyrate (BLM) or placebo for 2 months, in addition to conventional therapy. Eighteen healthy volunteers (HVs) were recruited to provide a healthy microbiota model of the local people. Fecal microbiota from stool samples was assessed by 16S sequencing. Clinical disease activity and quality of life (QoL) were evaluated before and after treatment. KEY RESULTS: At baseline, HVs showed a different microbiota composition compared with IBD patients. Sodium-butyrate altered the gut microbiota of IBD patients by increasing bacteria able to produce SCFA in UC patients (Lachnospiraceae spp.) and the butyrogenic colonic bacteria in CD patients (Butyricicoccus). In UC patients, QoL was positively affected by treatment. CONCLUSIONS AND INFERENCES: Sodium-butyrate supplementation increases the growth of bacteria able to produce SCFA with potentially anti-inflammatory action. The clinical impact of this finding requires further investigation.