Gionata Fiorino - Academia.edu (original) (raw)
Papers by Gionata Fiorino
Alimentary Pharmacology & Therapeutics, 2012
HAL is a multidisciplinary open access archive for the deposit and dissemination of scientific re... more HAL is a multidisciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L'archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d'enseignement et de recherche français ou étrangers, des laboratoires publics ou privés.
Journal of Clinical Medicine
The histological assessment has been advocated as a detailed and accurate measure of disease acti... more The histological assessment has been advocated as a detailed and accurate measure of disease activity in inflammatory bowel diseases (IBD). In ulcerative colitis (UC), histological activity has been demonstrated to be associated with higher rates of relapse, prolonged corticosteroid use and long-term complications, even when endoscopic remission is achieved. Therefore, histological healing may represent a potential treatment target. Several histological scores have been developed and are available today. The Robarts histopathology index (RHI) and the Nancy index (NI) are the only two recommended by the European Crohn’s and Colitis Organization (ECCO) for use in patients with UC. Conversely, in Crohn’s disease (CD), the discontinuous nature of lesions has limited standardized histological assessment. Most of the available histological scoring systems in CD are complex and not validated. The aim of this review is to comprehensively summarize the latest evidence regarding histological ...
Supplemental material, sj-pdf-1-tag-10.1177_17562848211005692 for Rediscovering histology: what i... more Supplemental material, sj-pdf-1-tag-10.1177_17562848211005692 for Rediscovering histology: what is new in endoscopy for inflammatory bowel disease? by Virginia Solitano, Ferdinando D'Amico, Mariangela Allocca, Gionata Fiorino, Alessandra Zilli, Laura Loy, Daniela Gilardi, Simona Radice, Carmen Correale, Silvio Danese, Laurent Peyrin-Biroulet and Federica Furfaro in Therapeutic Advances in Gastroenterology
Journal of Clinical Medicine, 2022
Endoscopy is the mainstay of inflammatory bowel disease (IBD) evaluation and the pillar of colore... more Endoscopy is the mainstay of inflammatory bowel disease (IBD) evaluation and the pillar of colorectal cancer surveillance. Endoscopic equipment, both hardware and software, are advancing at an incredible pace. Virtual chromoendoscopy is now widely available, allowing the detection of subtle inflammatory changes, thus reducing the gap between endoscopic and histologic assessment. The progress in the field of artificial intelligence (AI) has been remarkable, and numerous applications are now in an advanced stage of development. Computer-aided diagnosis (CAD) systems are likely to reshape most of the evaluations that are now prerogative of human endoscopists. Furthermore, sophisticated tools such as endocytoscopy and probe-based confocal laser endomicroscopy (pCLE) are enhancing our assessment of inflammation and dysplasia. Finally, pCLE combined with molecular labeling could pave the way to a new paradigm of personalized medicine. This review aims to summarize the main changes that oc...
Journal of Clinical Medicine, 2022
Artificial intelligence (AI) is assuming an increasingly important and central role in several me... more Artificial intelligence (AI) is assuming an increasingly important and central role in several medical fields. Its application in endoscopy provides a powerful tool supporting human experiences in the detection, characterization, and classification of gastrointestinal lesions. Lately, the potential of AI technology has been emerging in the field of inflammatory bowel disease (IBD), where the current cornerstone is the treat-to-target strategy. A sensible and specific tool able to overcome human limitations, such as AI, could represent a great ally and guide precision medicine decisions. Here we reviewed the available literature on the endoscopic applications of AI in order to properly describe the current state-of-the-art and identify the research gaps in IBD at the dawn of 2022.
Journal of Clinical Medicine, 2022
Subjects affected by ulcerative colitis and Crohn’s disease with colonic localization have an inc... more Subjects affected by ulcerative colitis and Crohn’s disease with colonic localization have an increased risk of colorectal cancer (CRC). Surveillance colonoscopy is recommended by international guidelines as it can detect early-stage CRC. Based on previous evidence, in 2015 the Surveillance for Colorectal Endoscopic Neoplasia Detection and Management in Inflammatory Bowel Disease Patients International Consensus indicated dye chromoendoscopy (DCE) as the most effective technique for detecting dysplasia. However, advances in endoscopic technology such as high-definition colonoscopes and dye-less virtual chromoendoscopy (VCE) may change future practice. In this review, we summarize the available evidence on CRC surveillance in IBD, focusing on the emerging role of high-definition white light endoscopy (HD-WLE) and VCE over the standard DCE, and the current role of random biopsies.
Gastroenterology, 2019
time from CD diagnosis to first 5-ASA script (correlation: p<0.001); use of an oral 5-ASA formula... more time from CD diagnosis to first 5-ASA script (correlation: p<0.001); use of an oral 5-ASA formulation at initiation (correlation: tablets: p<0.001; granules: p=0.008); and dose optimisation (increase: 89.3 months, decrease: 111.4 months vs. 45.5 months for no change; both p<0.001). Conclusion: These data indicates that 5-ASA is used as a long-term treatment for CD, as evidenced by continuation rates extending beyond 10 years in a quarter of patients, and this is linked to relatively low levels of hospitalisations, surgery and supplementary treatments requirements. Moreover, patients that started 5-ASA earlier after diagnosis stayed on therapy significantly longer.
United European Gastroenterology Journal, 2020
Background and aims: Restructuring activities have been necessary during the lockdown phase of th... more Background and aims: Restructuring activities have been necessary during the lockdown phase of the coronavirus disease 2019 (COVID-19) pandemic. Few data are available on the post-lockdown phase in terms of health-care procedures in inflammatory bowel disease (IBD) care, and no data are available specifically from IBD units. We aimed to investigate how IBD management was restructured during the lockdown phase, the impact of the restructuring on standards of care and how Italian IBD units have managed post-lockdown activities. Methods: A web-based online survey was conducted in two phases (April and June 2020) among the Italian Group for IBD affiliated units within the entire country. We investigated preventive measures, the possibility of continuing scheduled visits/procedures/therapies because of COVID-19 and how units resumed activities in the post-lockdown phase. Results: Forty-two referral centres participated from all over Italy. During the COVID-19 lockdown, 36% of first visits and 7% of follow-up visits were regularly done, while >70% of follow-up scheduled visits and 5% of first visits were done virtually. About 25% of scheduled endoscopies and bowel ultrasound scans were done. More than 80% of biological therapies were done as scheduled. Compared to the pre-lockdown situation, 95% of centres modified management of outpatient activity, 93% of endoscopies, 59% of gastrointestinal ultrasounds and 33% of biological therapies. Resumption of activities after the lockdown phase may take three to six months to normalize. Virtual clinics, implementation of IBD pathways and facilities seem to be the main factors to improve care in the future. Conclusion: Italian IBD unit restructuring allowed quality standards of care during the COVID-19 pandemic to be maintained. A return to normal appears to be feasible and achievable relatively quickly. Some approaches, such as virtual clinics and identified IBD pathways, represent a valid starting point to improve IBD care in the post-COVID-19 era.
Journal of Crohn's and Colitis, 2020
Background and Aims Dual targeted therapy [DTT] has been proposed as a novel therapeutic strategy... more Background and Aims Dual targeted therapy [DTT] has been proposed as a novel therapeutic strategy for the management of complicated patients with inflammatory bowel diseases [IBD]. Our aim here was to investigate the safety and effectiveness of this approach in a real-life setting. Methods We retrospectively extracted data from IBD patients receiving DTT in Italian IBD referral centres. Baseline characteristics, clinical activity of intestinal and extra-intestinal disease, and C-reactive protein levels were recorded. All adverse events were reported. Clinical effectiveness, biochemical remission and safety of DTT were investigated. Results Sixteen patients were identified; indications for DTT were: ‘active IBD’ or ‘active EIM’ despite ongoing biological therapy. The most commonly used DTT were: vedolizumab + ustekinumab [three patients] and vedolizumab + adalimumab [three patients]. Clinical response of intestinal or extra-intestinal symptoms, according to the indication for DTT, wa...
Journal of Crohn's and Colitis, 2020
Introduction Diagnostic delay >12 months is frequent in Crohn’s disease [CD]. Recently, the In... more Introduction Diagnostic delay >12 months is frequent in Crohn’s disease [CD]. Recently, the International Organization for Inflammatory Bowel Disease [IO-IBD] developed a tool to identify early CD and reduce diagnostic delay. Subjects with an index ≥8 are more likely to have suspected CD (odds ratio [OR] 205, p <0.0001). We aimed to validate this questionnaire at the community level in patients seen by the general practitioners [GPs] in two large areas of Lombardy, Italy. Methods Consecutive adult patients referring to the GP were screened. The GPs administered the Red Flags [RF] questionnaire to the eligible patients. All patients were referred to the nearest participating centre to confirm or exclude the diagnosis of CD. Sensitivity, specificity, and positive and negative predictive values [PPV, NPV] of the RF index [RFI] were calculated. Patients lost to follow-up after the first gastroenterological visit were analysed using a non-responder imputation, assuming they were ne...
Gastroenterology, 2020
µg/g at baseline, the proportion of patients achieving FCP £250 µg/g was 33.9% vs 24.5% at Week 3... more µg/g at baseline, the proportion of patients achieving FCP £250 µg/g was 33.9% vs 24.5% at Week 30 and 35.2% vs 28.9% at Week 52 for patients treated with vedolizumab vs adalimumab, respectively. Conclusion: Based on IBDQ total score and subscores, more patients with ulcerative colitis treated with vedolizumab than with adalimumab achieved clinically meaningful improvement and clinical remission. Reduced inflammation, as indicated by improvements in C-reactive protein and FCP, was consistent with improvements in QOL.
![Research paper thumbnail of Quality of Care Standards in Inflammatory Bowel Diseases: a European Crohn’s and Colitis Organisation [ECCO] Position Paper](https://attachments.academia-assets.com/93636657/thumbnails/1.jpg)
](Journal of Crohn's and Colitis, 2020
The management of inflammatory bowel disease [IBD] is complex, and requires tight control of dise... more The management of inflammatory bowel disease [IBD] is complex, and requires tight control of disease activity, close monitoring to avoid treatment side effects, health care professionals with expertise in IBD, and an interdisciplinary, holistic approach. Despite various efforts to standardise structures, processes, and outcomes,1–8 and due to the high variability at the local, national, and international levels, there are still no clear definitions or outcome measures available to establish quality of care standards for IBD patients which are applicable in all contexts and all countries. For this reason, the European Crohn’s and Colitis Organisation [ECCO] supported the construction of a list of criteria summarising current standards of care in IBD. The list comprises 111 quality standard points grouped into three main domains [structure n = 31, process n = 42, outcomes n = 38] and is based on scientific evidence, interdisciplinary expert consensus, and patient-oriented perspectives...
Best practice & research. Clinical gastroenterology
Janus kinase inhibitors are small molecules, orally administered, under development for the treat... more Janus kinase inhibitors are small molecules, orally administered, under development for the treatment of ulcerative colitis. These molecules reduce the immune response, blocking the signal transduction of multiple cytokines implicated in the activation of inflammation. Currently multiple JAK inhibitors are being evaluated in clinical trials. The aim of this review is to examine the efficacy and the safety of the JAK inhibitors being tested and to discuss the available data on the use of these drugs in moderate-to-severe ulcerative colitis, in order to understand how these new molecules can fit into the therapeutic algorithm of patients with ulcerative colitis.
Current drug targets, Jan 2, 2017
Personalized medicine is becoming a widespread effort to provide the right treatment to the right... more Personalized medicine is becoming a widespread effort to provide the right treatment to the right patient at the right time. However, it lacks of consideration for nonmedical factors, such as patient preferences and psychosocial factors, that should not be avoided. The present study summarizes the psychosocial difficulties experienced by patients with inflammatory bowel disease (IBD) during different phases of the disease in order to identify methods to assess psychosocial risk factors and personalize treatment strategies. To reach this goal, the quantitative literature is matched with the patients' perspective, offering a broad overview of psychosocial risk factors that IBD patients experience. Quantitative results offer strong evidences for specific psychosocial risk factors in IBD and for weak results of psychosocial interventions, but show a lack of individually tailored researches, instruments and interventions, increasing the distance between the research findings and cli...
Gut, 2015
Background Crohn's disease (CD) is a chronic disabling and progressive IBD. Only strategies l... more Background Crohn's disease (CD) is a chronic disabling and progressive IBD. Only strategies looking beyond symptoms and based on tight monitoring of objective signs of inflammation such as mucosal lesions may have the potential for disease modification. Endoscopic evaluation is currently the gold standard to assess mucosal lesions and has become a major therapeutic endpoint in clinical trials. Several endoscopic indices have been proposed to evaluate disease activity; unvalidated and arbitrary definitions have been used in clinical trials for defining endoscopic response and endoscopic remission in CD. Methods In these recommendations from the International Organization for the Study of Inflammatory Bowel Disease, we first reviewed all technical aspects of available endoscopic scoring systems in the literature. Second, in order to achieve consensus on endoscopic definitions of remission and response in trials, a two-round vote based on a Delphi method was performed among 14 specialists in the field of IBDs. Results At the end of the voting process, the investigators ranked first a >50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) or Crohn's Disease Endoscopic Index of Severity for the definition of endoscopic response, and an SES-CD 0–2 for the definition of endoscopic remission in CD. All experts agreed on a Rutgeerts’ score i0–i1 for the definition of endoscopic remission after surgery.
Gastroenterology, 2017
Figure 1: Differential permeability morbidity, and mortality changes induced by DSS in zonulin tr... more Figure 1: Differential permeability morbidity, and mortality changes induced by DSS in zonulin transgenic HP2 mice compared to WT mice. A. In vivo small intestinal gut permeability at baseline in HP2 mice was increased compared to WT mice and further dropped after 7d DSS treatment + 4 days recovery despite no tissue damage. B,C. DSS caused a more severe impairment of gut barrier in the small intestine of HP2 mice compared to WT mice, despite absence of structural damage. D. DSS caused a more severe loss of barrier function in the colon of HP2 mice compared to WT mice commensurate to tissue damage. E. HP2 mice treated with DSS showed 70% mortality compared to 0% in untreated animals (both HP2 and WT) and WT mice treated with DSS. F: WT animals treated with DSS showed weight recovery after withdrawal of DSS, while HP2 animals continued to lose weight. *p<0.05; **p<0.01; ***p<0.001
Gastrointestinal Endoscopy, 2016
Non-experts (N[4) Ovarall accuracy 89% 92% 73% Accuracy when diagnosing with high confidence 98% ... more Non-experts (N[4) Ovarall accuracy 89% 92% 73% Accuracy when diagnosing with high confidence 98% 97% 79% Rate of high confidence prediction 80% 81% 79% Time for diagnosis per lesion (seconds) 0.2 8.7 12.2 EC-CAD, computer-aided diagnosic system for endocytoscopic imaging Output image of EC-CAD (computer-aided diagnostic system for endocytoscopic imaging)
European Journal of Gastroenterology & Hepatology, 2016
Introduction Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for d... more Introduction Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for decades. Nevertheless, current data provide equivocal evidence on the efficacy of MTX in CD. The aims of this study were to describe the efficacy of MTX for maintenance of remission in CD and to identify the factors associated with the probability of steroid-free clinical remission in a multicenter European referral center cohort. Patients and methods This was a retrospective cohort analysis. Consecutive patients treated with MTX for CD were included from 11 referral centers. Patients receiving concomitant treatment with tumor necrosis factor inhibitors or thiopurines were excluded. The main outcome was steroid-free clinical remission; the secondary outcomes included the rate of complications leading to MTX discontinuation and duration of relapse-free survival in patients achieving the main outcome. Results Between July 1992 and January 2012, 118 patients were identified for inclusion. MTX administration route was oral for induction in 31.4% and for maintenance in 49.1% of the patients. Steroid-free remission was achieved in 44/118 (37.2%) patients and was maintained relapse free by 28/44 (63.6%) for a median of 12 (3.5-18.5) months. At least one adverse effect was reported by 28.9% of the patients. No clinical or demographic factors were associated with either likelihood of achieving a clinical response or duration of relapse-free survival. Conclusion MTX treatment induced steroid-free clinical remission in over a third of CD patients and maintained it for a year in almost two-thirds of the responders. MTX should be considered a viable therapeutic option in CD patients refractory to other therapies.
Gastroenterology, 2012
BACKGROUND: There are limited treatment options for patients with corticosteroid refractory ulcer... more BACKGROUND: There are limited treatment options for patients with corticosteroid refractory ulcerative colitis (UC). Tacrolimus belongs to a group of medicines known as immunosuppressive agents. Animal models of inflammatory bowel disease and uncontrolled studies in humans suggest that Tacrolimus may be an effective medication for patients with UC. Accordingly, although almost exclusively used in trial cases, Tacrolimus has shown significant efficacy in the suppression of UC relapse. This study compared the efficacy of oral Tacrolimus vs Cyclosporine (Cs)A in patients with UC, refractory to corticosteroids. METHODS: Between January 2006 and January 2011, a total of 113 patients with UC, all corticosteroid refractory were included in this study. The patients were randomly assigned to two groups, CsA (n= 80; 40 male and 40 female, average age 34.7 ± 13.9 years) and Tacrolimus (n=33, 23 male and 10 female, average age 41.4 ± 15.7 years). Lichtiger's clinical activity index (CAI) was applied to assess UC activity and treatment efficacy. Following an initial 14 days of remission induction therapy with CsA (2mg/kg body weight/day, iv) or Tacrolimus (0.05-0.15mg/kg body weight/day), patients who achieved a CAI score of 3 or better were followed for 12 months. During the 12 months follow-up time, maintenance rate of remission was monitored by using the Kaplan-Meier graphs for survival analyses. RESULTS: In the CsA group, the average CAI scores before and after the initial two weeks of treatment were 13.1 ± 2.92 and 5.6 ± 3.35, respectively (P<0.0001). The corresponding CAI scores in the Tacrolimus group were 9.75 ± 3.27 and 5.0±3.84, respectively (P<0.01). The clinical remission rates (CAI = 3 or better) after the initial two weeks of treatment were 30.0% (24 of 80 patients) in the CsA group and 45.4% (15 of 33 patients) in the Tacrolimus group, the difference was not statistically significant (P=0.11). Further, response rates (a decrease in CAI by at least 4 points) were 77.5% (62 of 80 patients) in the CsA group and 69.7% (23 of 33 patients) in the Tacrolimus group. Again, the difference did not reach significance level (P= 0.38). Likewise, the rates of remission maintenance at 12 months were 35.2% in the CsA group and 33.7% in the Tacrolimus group. The difference did not reach significance level (P= 0.26). CONCLUSIONS: In this study involving 113 patients with UC of corticosteroid refractory background, Tacrolimus and CsA showed similar efficacy both in the rate of remission induction and maintenance of remission.
Alimentary Pharmacology & Therapeutics, 2012
HAL is a multidisciplinary open access archive for the deposit and dissemination of scientific re... more HAL is a multidisciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L'archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d'enseignement et de recherche français ou étrangers, des laboratoires publics ou privés.
Journal of Clinical Medicine
The histological assessment has been advocated as a detailed and accurate measure of disease acti... more The histological assessment has been advocated as a detailed and accurate measure of disease activity in inflammatory bowel diseases (IBD). In ulcerative colitis (UC), histological activity has been demonstrated to be associated with higher rates of relapse, prolonged corticosteroid use and long-term complications, even when endoscopic remission is achieved. Therefore, histological healing may represent a potential treatment target. Several histological scores have been developed and are available today. The Robarts histopathology index (RHI) and the Nancy index (NI) are the only two recommended by the European Crohn’s and Colitis Organization (ECCO) for use in patients with UC. Conversely, in Crohn’s disease (CD), the discontinuous nature of lesions has limited standardized histological assessment. Most of the available histological scoring systems in CD are complex and not validated. The aim of this review is to comprehensively summarize the latest evidence regarding histological ...
Supplemental material, sj-pdf-1-tag-10.1177_17562848211005692 for Rediscovering histology: what i... more Supplemental material, sj-pdf-1-tag-10.1177_17562848211005692 for Rediscovering histology: what is new in endoscopy for inflammatory bowel disease? by Virginia Solitano, Ferdinando D'Amico, Mariangela Allocca, Gionata Fiorino, Alessandra Zilli, Laura Loy, Daniela Gilardi, Simona Radice, Carmen Correale, Silvio Danese, Laurent Peyrin-Biroulet and Federica Furfaro in Therapeutic Advances in Gastroenterology
Journal of Clinical Medicine, 2022
Endoscopy is the mainstay of inflammatory bowel disease (IBD) evaluation and the pillar of colore... more Endoscopy is the mainstay of inflammatory bowel disease (IBD) evaluation and the pillar of colorectal cancer surveillance. Endoscopic equipment, both hardware and software, are advancing at an incredible pace. Virtual chromoendoscopy is now widely available, allowing the detection of subtle inflammatory changes, thus reducing the gap between endoscopic and histologic assessment. The progress in the field of artificial intelligence (AI) has been remarkable, and numerous applications are now in an advanced stage of development. Computer-aided diagnosis (CAD) systems are likely to reshape most of the evaluations that are now prerogative of human endoscopists. Furthermore, sophisticated tools such as endocytoscopy and probe-based confocal laser endomicroscopy (pCLE) are enhancing our assessment of inflammation and dysplasia. Finally, pCLE combined with molecular labeling could pave the way to a new paradigm of personalized medicine. This review aims to summarize the main changes that oc...
Journal of Clinical Medicine, 2022
Artificial intelligence (AI) is assuming an increasingly important and central role in several me... more Artificial intelligence (AI) is assuming an increasingly important and central role in several medical fields. Its application in endoscopy provides a powerful tool supporting human experiences in the detection, characterization, and classification of gastrointestinal lesions. Lately, the potential of AI technology has been emerging in the field of inflammatory bowel disease (IBD), where the current cornerstone is the treat-to-target strategy. A sensible and specific tool able to overcome human limitations, such as AI, could represent a great ally and guide precision medicine decisions. Here we reviewed the available literature on the endoscopic applications of AI in order to properly describe the current state-of-the-art and identify the research gaps in IBD at the dawn of 2022.
Journal of Clinical Medicine, 2022
Subjects affected by ulcerative colitis and Crohn’s disease with colonic localization have an inc... more Subjects affected by ulcerative colitis and Crohn’s disease with colonic localization have an increased risk of colorectal cancer (CRC). Surveillance colonoscopy is recommended by international guidelines as it can detect early-stage CRC. Based on previous evidence, in 2015 the Surveillance for Colorectal Endoscopic Neoplasia Detection and Management in Inflammatory Bowel Disease Patients International Consensus indicated dye chromoendoscopy (DCE) as the most effective technique for detecting dysplasia. However, advances in endoscopic technology such as high-definition colonoscopes and dye-less virtual chromoendoscopy (VCE) may change future practice. In this review, we summarize the available evidence on CRC surveillance in IBD, focusing on the emerging role of high-definition white light endoscopy (HD-WLE) and VCE over the standard DCE, and the current role of random biopsies.
Gastroenterology, 2019
time from CD diagnosis to first 5-ASA script (correlation: p<0.001); use of an oral 5-ASA formula... more time from CD diagnosis to first 5-ASA script (correlation: p<0.001); use of an oral 5-ASA formulation at initiation (correlation: tablets: p<0.001; granules: p=0.008); and dose optimisation (increase: 89.3 months, decrease: 111.4 months vs. 45.5 months for no change; both p<0.001). Conclusion: These data indicates that 5-ASA is used as a long-term treatment for CD, as evidenced by continuation rates extending beyond 10 years in a quarter of patients, and this is linked to relatively low levels of hospitalisations, surgery and supplementary treatments requirements. Moreover, patients that started 5-ASA earlier after diagnosis stayed on therapy significantly longer.
United European Gastroenterology Journal, 2020
Background and aims: Restructuring activities have been necessary during the lockdown phase of th... more Background and aims: Restructuring activities have been necessary during the lockdown phase of the coronavirus disease 2019 (COVID-19) pandemic. Few data are available on the post-lockdown phase in terms of health-care procedures in inflammatory bowel disease (IBD) care, and no data are available specifically from IBD units. We aimed to investigate how IBD management was restructured during the lockdown phase, the impact of the restructuring on standards of care and how Italian IBD units have managed post-lockdown activities. Methods: A web-based online survey was conducted in two phases (April and June 2020) among the Italian Group for IBD affiliated units within the entire country. We investigated preventive measures, the possibility of continuing scheduled visits/procedures/therapies because of COVID-19 and how units resumed activities in the post-lockdown phase. Results: Forty-two referral centres participated from all over Italy. During the COVID-19 lockdown, 36% of first visits and 7% of follow-up visits were regularly done, while >70% of follow-up scheduled visits and 5% of first visits were done virtually. About 25% of scheduled endoscopies and bowel ultrasound scans were done. More than 80% of biological therapies were done as scheduled. Compared to the pre-lockdown situation, 95% of centres modified management of outpatient activity, 93% of endoscopies, 59% of gastrointestinal ultrasounds and 33% of biological therapies. Resumption of activities after the lockdown phase may take three to six months to normalize. Virtual clinics, implementation of IBD pathways and facilities seem to be the main factors to improve care in the future. Conclusion: Italian IBD unit restructuring allowed quality standards of care during the COVID-19 pandemic to be maintained. A return to normal appears to be feasible and achievable relatively quickly. Some approaches, such as virtual clinics and identified IBD pathways, represent a valid starting point to improve IBD care in the post-COVID-19 era.
Journal of Crohn's and Colitis, 2020
Background and Aims Dual targeted therapy [DTT] has been proposed as a novel therapeutic strategy... more Background and Aims Dual targeted therapy [DTT] has been proposed as a novel therapeutic strategy for the management of complicated patients with inflammatory bowel diseases [IBD]. Our aim here was to investigate the safety and effectiveness of this approach in a real-life setting. Methods We retrospectively extracted data from IBD patients receiving DTT in Italian IBD referral centres. Baseline characteristics, clinical activity of intestinal and extra-intestinal disease, and C-reactive protein levels were recorded. All adverse events were reported. Clinical effectiveness, biochemical remission and safety of DTT were investigated. Results Sixteen patients were identified; indications for DTT were: ‘active IBD’ or ‘active EIM’ despite ongoing biological therapy. The most commonly used DTT were: vedolizumab + ustekinumab [three patients] and vedolizumab + adalimumab [three patients]. Clinical response of intestinal or extra-intestinal symptoms, according to the indication for DTT, wa...
Journal of Crohn's and Colitis, 2020
Introduction Diagnostic delay >12 months is frequent in Crohn’s disease [CD]. Recently, the In... more Introduction Diagnostic delay >12 months is frequent in Crohn’s disease [CD]. Recently, the International Organization for Inflammatory Bowel Disease [IO-IBD] developed a tool to identify early CD and reduce diagnostic delay. Subjects with an index ≥8 are more likely to have suspected CD (odds ratio [OR] 205, p <0.0001). We aimed to validate this questionnaire at the community level in patients seen by the general practitioners [GPs] in two large areas of Lombardy, Italy. Methods Consecutive adult patients referring to the GP were screened. The GPs administered the Red Flags [RF] questionnaire to the eligible patients. All patients were referred to the nearest participating centre to confirm or exclude the diagnosis of CD. Sensitivity, specificity, and positive and negative predictive values [PPV, NPV] of the RF index [RFI] were calculated. Patients lost to follow-up after the first gastroenterological visit were analysed using a non-responder imputation, assuming they were ne...
Gastroenterology, 2020
µg/g at baseline, the proportion of patients achieving FCP £250 µg/g was 33.9% vs 24.5% at Week 3... more µg/g at baseline, the proportion of patients achieving FCP £250 µg/g was 33.9% vs 24.5% at Week 30 and 35.2% vs 28.9% at Week 52 for patients treated with vedolizumab vs adalimumab, respectively. Conclusion: Based on IBDQ total score and subscores, more patients with ulcerative colitis treated with vedolizumab than with adalimumab achieved clinically meaningful improvement and clinical remission. Reduced inflammation, as indicated by improvements in C-reactive protein and FCP, was consistent with improvements in QOL.
Journal of Crohn's and Colitis, 2020
The management of inflammatory bowel disease [IBD] is complex, and requires tight control of dise... more The management of inflammatory bowel disease [IBD] is complex, and requires tight control of disease activity, close monitoring to avoid treatment side effects, health care professionals with expertise in IBD, and an interdisciplinary, holistic approach. Despite various efforts to standardise structures, processes, and outcomes,1–8 and due to the high variability at the local, national, and international levels, there are still no clear definitions or outcome measures available to establish quality of care standards for IBD patients which are applicable in all contexts and all countries. For this reason, the European Crohn’s and Colitis Organisation [ECCO] supported the construction of a list of criteria summarising current standards of care in IBD. The list comprises 111 quality standard points grouped into three main domains [structure n = 31, process n = 42, outcomes n = 38] and is based on scientific evidence, interdisciplinary expert consensus, and patient-oriented perspectives...
Best practice & research. Clinical gastroenterology
Janus kinase inhibitors are small molecules, orally administered, under development for the treat... more Janus kinase inhibitors are small molecules, orally administered, under development for the treatment of ulcerative colitis. These molecules reduce the immune response, blocking the signal transduction of multiple cytokines implicated in the activation of inflammation. Currently multiple JAK inhibitors are being evaluated in clinical trials. The aim of this review is to examine the efficacy and the safety of the JAK inhibitors being tested and to discuss the available data on the use of these drugs in moderate-to-severe ulcerative colitis, in order to understand how these new molecules can fit into the therapeutic algorithm of patients with ulcerative colitis.
Current drug targets, Jan 2, 2017
Personalized medicine is becoming a widespread effort to provide the right treatment to the right... more Personalized medicine is becoming a widespread effort to provide the right treatment to the right patient at the right time. However, it lacks of consideration for nonmedical factors, such as patient preferences and psychosocial factors, that should not be avoided. The present study summarizes the psychosocial difficulties experienced by patients with inflammatory bowel disease (IBD) during different phases of the disease in order to identify methods to assess psychosocial risk factors and personalize treatment strategies. To reach this goal, the quantitative literature is matched with the patients' perspective, offering a broad overview of psychosocial risk factors that IBD patients experience. Quantitative results offer strong evidences for specific psychosocial risk factors in IBD and for weak results of psychosocial interventions, but show a lack of individually tailored researches, instruments and interventions, increasing the distance between the research findings and cli...
Gut, 2015
Background Crohn's disease (CD) is a chronic disabling and progressive IBD. Only strategies l... more Background Crohn's disease (CD) is a chronic disabling and progressive IBD. Only strategies looking beyond symptoms and based on tight monitoring of objective signs of inflammation such as mucosal lesions may have the potential for disease modification. Endoscopic evaluation is currently the gold standard to assess mucosal lesions and has become a major therapeutic endpoint in clinical trials. Several endoscopic indices have been proposed to evaluate disease activity; unvalidated and arbitrary definitions have been used in clinical trials for defining endoscopic response and endoscopic remission in CD. Methods In these recommendations from the International Organization for the Study of Inflammatory Bowel Disease, we first reviewed all technical aspects of available endoscopic scoring systems in the literature. Second, in order to achieve consensus on endoscopic definitions of remission and response in trials, a two-round vote based on a Delphi method was performed among 14 specialists in the field of IBDs. Results At the end of the voting process, the investigators ranked first a >50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) or Crohn's Disease Endoscopic Index of Severity for the definition of endoscopic response, and an SES-CD 0–2 for the definition of endoscopic remission in CD. All experts agreed on a Rutgeerts’ score i0–i1 for the definition of endoscopic remission after surgery.
Gastroenterology, 2017
Figure 1: Differential permeability morbidity, and mortality changes induced by DSS in zonulin tr... more Figure 1: Differential permeability morbidity, and mortality changes induced by DSS in zonulin transgenic HP2 mice compared to WT mice. A. In vivo small intestinal gut permeability at baseline in HP2 mice was increased compared to WT mice and further dropped after 7d DSS treatment + 4 days recovery despite no tissue damage. B,C. DSS caused a more severe impairment of gut barrier in the small intestine of HP2 mice compared to WT mice, despite absence of structural damage. D. DSS caused a more severe loss of barrier function in the colon of HP2 mice compared to WT mice commensurate to tissue damage. E. HP2 mice treated with DSS showed 70% mortality compared to 0% in untreated animals (both HP2 and WT) and WT mice treated with DSS. F: WT animals treated with DSS showed weight recovery after withdrawal of DSS, while HP2 animals continued to lose weight. *p<0.05; **p<0.01; ***p<0.001
Gastrointestinal Endoscopy, 2016
Non-experts (N[4) Ovarall accuracy 89% 92% 73% Accuracy when diagnosing with high confidence 98% ... more Non-experts (N[4) Ovarall accuracy 89% 92% 73% Accuracy when diagnosing with high confidence 98% 97% 79% Rate of high confidence prediction 80% 81% 79% Time for diagnosis per lesion (seconds) 0.2 8.7 12.2 EC-CAD, computer-aided diagnosic system for endocytoscopic imaging Output image of EC-CAD (computer-aided diagnostic system for endocytoscopic imaging)
European Journal of Gastroenterology & Hepatology, 2016
Introduction Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for d... more Introduction Methotrexate (MTX) has been utilized for the treatment of Crohn's disease (CD) for decades. Nevertheless, current data provide equivocal evidence on the efficacy of MTX in CD. The aims of this study were to describe the efficacy of MTX for maintenance of remission in CD and to identify the factors associated with the probability of steroid-free clinical remission in a multicenter European referral center cohort. Patients and methods This was a retrospective cohort analysis. Consecutive patients treated with MTX for CD were included from 11 referral centers. Patients receiving concomitant treatment with tumor necrosis factor inhibitors or thiopurines were excluded. The main outcome was steroid-free clinical remission; the secondary outcomes included the rate of complications leading to MTX discontinuation and duration of relapse-free survival in patients achieving the main outcome. Results Between July 1992 and January 2012, 118 patients were identified for inclusion. MTX administration route was oral for induction in 31.4% and for maintenance in 49.1% of the patients. Steroid-free remission was achieved in 44/118 (37.2%) patients and was maintained relapse free by 28/44 (63.6%) for a median of 12 (3.5-18.5) months. At least one adverse effect was reported by 28.9% of the patients. No clinical or demographic factors were associated with either likelihood of achieving a clinical response or duration of relapse-free survival. Conclusion MTX treatment induced steroid-free clinical remission in over a third of CD patients and maintained it for a year in almost two-thirds of the responders. MTX should be considered a viable therapeutic option in CD patients refractory to other therapies.
Gastroenterology, 2012
BACKGROUND: There are limited treatment options for patients with corticosteroid refractory ulcer... more BACKGROUND: There are limited treatment options for patients with corticosteroid refractory ulcerative colitis (UC). Tacrolimus belongs to a group of medicines known as immunosuppressive agents. Animal models of inflammatory bowel disease and uncontrolled studies in humans suggest that Tacrolimus may be an effective medication for patients with UC. Accordingly, although almost exclusively used in trial cases, Tacrolimus has shown significant efficacy in the suppression of UC relapse. This study compared the efficacy of oral Tacrolimus vs Cyclosporine (Cs)A in patients with UC, refractory to corticosteroids. METHODS: Between January 2006 and January 2011, a total of 113 patients with UC, all corticosteroid refractory were included in this study. The patients were randomly assigned to two groups, CsA (n= 80; 40 male and 40 female, average age 34.7 ± 13.9 years) and Tacrolimus (n=33, 23 male and 10 female, average age 41.4 ± 15.7 years). Lichtiger's clinical activity index (CAI) was applied to assess UC activity and treatment efficacy. Following an initial 14 days of remission induction therapy with CsA (2mg/kg body weight/day, iv) or Tacrolimus (0.05-0.15mg/kg body weight/day), patients who achieved a CAI score of 3 or better were followed for 12 months. During the 12 months follow-up time, maintenance rate of remission was monitored by using the Kaplan-Meier graphs for survival analyses. RESULTS: In the CsA group, the average CAI scores before and after the initial two weeks of treatment were 13.1 ± 2.92 and 5.6 ± 3.35, respectively (P<0.0001). The corresponding CAI scores in the Tacrolimus group were 9.75 ± 3.27 and 5.0±3.84, respectively (P<0.01). The clinical remission rates (CAI = 3 or better) after the initial two weeks of treatment were 30.0% (24 of 80 patients) in the CsA group and 45.4% (15 of 33 patients) in the Tacrolimus group, the difference was not statistically significant (P=0.11). Further, response rates (a decrease in CAI by at least 4 points) were 77.5% (62 of 80 patients) in the CsA group and 69.7% (23 of 33 patients) in the Tacrolimus group. Again, the difference did not reach significance level (P= 0.38). Likewise, the rates of remission maintenance at 12 months were 35.2% in the CsA group and 33.7% in the Tacrolimus group. The difference did not reach significance level (P= 0.26). CONCLUSIONS: In this study involving 113 patients with UC of corticosteroid refractory background, Tacrolimus and CsA showed similar efficacy both in the rate of remission induction and maintenance of remission.