Publications by authors named "Gionata Fiorino"

186 Publications

ECCO Guidelines on Therapeutics in Ulcerative Colitis: Surgical Treatment.

J Crohns Colitis 2021 Oct 12. Epub 2021 Oct 12.

Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.

This is the second of a series of two articles reporting the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the management of adult patients with ulcerative colitis [UC]. The first article is focused on medical management and the present article addresses medical treatment of acute severe ulcerative colitis [ASUC] and surgical management of medically refractory UC patients, including preoperative optimization, surgical strategies, and technical issues. The article provides advice for a variety of common clinical and surgical conditions. Together, the articles represent an update of the evidence-based recommendations of the ECCO for UC.
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http://dx.doi.org/10.1093/ecco-jcc/jjab177DOI Listing
October 2021

Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT-P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study.

Clin Transl Sci 2021 Sep 15. Epub 2021 Sep 15.

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Gastroenterology and Endoscopy Unit, Milan, Italy.

Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT-P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX-double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single-switched from originator IFX to CT-P13 was performed, before and after an inverse probability of treatment weighting (IPTW)-based propensity score analysis. Fifty-two double-switched patients with IBD were enrolled. The 24- and 52-week proportions of patients continuing on IFX therapy following the second switch (CTP13 → SB2) were 98% (95% confidence interval [CI] 94%-100%) and 90% (95% CI 81%-99%), respectively. Four patients experienced a total of five AEs, all graded 1-3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24-week and follow-up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double-switch group with a single-switch group of 66 patients with IBD; all these results were confirmed by IPTW-adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT-P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.
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http://dx.doi.org/10.1111/cts.13131DOI Listing
September 2021

Adalimumab biosimilar in inflammatory bowel disease.

Lancet Gastroenterol Hepatol 2021 10 11;6(10):775-776. Epub 2021 Aug 11.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan 20072, Italy; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.

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http://dx.doi.org/10.1016/S2468-1253(21)00266-1DOI Listing
October 2021

Viral infections in inflammatory bowel disease: Tips and tricks for correct management.

World J Gastroenterol 2021 Jul;27(27):4276-4297

Humanitas Clinical and Research Center, IRCCS, Rozzano 20089, Milano, Italy.

Over the past decades, the treatment of inflammatory bowel diseases (IBD) has become more targeted, anticipating the use of immune-modifying therapies at an earlier stage. This top-down approach has been correlated with favorable short and long-term outcomes, but it has also brought with it concerns regarding potential infectious complications. This large IBD population treated with immune-modifying therapies, especially if combined, has an increased risk of severe infections, including opportunistic infections that are sustained by viral, bacterial, parasitic, and fungal agents. Viral infections have emerged as a focal safety concern in patients with IBD, representing a challenge for the clinician: they are often difficult to diagnose and are associated with significant morbidity and mortality. The first step is to improve effective preventive strategies, such as applying vaccination protocols, adopt adequate prophylaxis and educate patients about potential risk factors. Since viral infections in immunosuppressed patients may present atypical signs and symptoms, the challenges for the gastroenterologist are to suspect, recognize and diagnose such complications. Appropriate treatment of common viral infections allows us to minimize their impact on disease outcomes and patients' lives. This practical review supports this standard of care to improve knowledge in this subject area.
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http://dx.doi.org/10.3748/wjg.v27.i27.4276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8316900PMC
July 2021

The new frontier: Certifying quality standards in the inflammatory bowel disease care.

United European Gastroenterol J 2021 Jul 10. Epub 2021 Jul 10.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

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http://dx.doi.org/10.1002/ueg2.12122DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8435243PMC
July 2021

The IL23-IL17 Immune Axis in the Treatment of Ulcerative Colitis: Successes, Defeats, and Ongoing Challenges.

Front Immunol 2021 17;12:611256. Epub 2021 May 17.

Inflammatory Bowel Disease (IBD) Center, Laboratory of Gastrointestinal Immunopathology, Humanitas Clinical and Research Center-IRCCS, Rozzano, Italy.

Ulcerative colitis (UC) is a chronic relapsing disorder of the colonic tract, characterized by a dysregulated innate and adaptive immune response to gut microbiota that contributes to the perpetuation of intestinal inflammatory processes. The Interleukin (IL) 23/IL17 axis has been reported to play a key role in UC pathogenesis promoting Th17 cells and cytokines-related immune response. Recently, the blockade of IL23/IL17 pathways has been raised enormous interest in the treatment o several chronic inflammatory disorders. In this review, we summarize the emerging results from clinical trials that evoked both promise and discouragement in IL23/IL17 axis in the treatment of UC. Targeting IL23 p40 through Ustekinumab results safe and effective to induce and maintain clinical remission, low inflammatory indexes, mucosal healing, and a better quality of life. Studies targeting IL23 p19 through Mirikizumab, Risankizumab, Brazikumab and Guselkumab are still ongoing. To date, no clinical studies targeting IL17 pathway are ongoing in UC. IL-17 targeting is thought to have a context-dependent biological effect, based on whether cytokine is selectively targeted or if its function is dampened by the upstream block of IL23.
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http://dx.doi.org/10.3389/fimmu.2021.611256DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8165319PMC
June 2021

Epidemiology and clinical course of late onset inflammatory bowel disease.

Minerva Gastroenterol (Torino) 2021 May 31. Epub 2021 May 31.

Gastroenterology and Clinical Unit for Chronic Bowel Disorders, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.

With the increasing age of the general population in developed countries, the management of several chronic diseases becomes more and more complex due to comorbidities. Some, especially inflammatory bowel diseases, formerly believed to belong to the young adult population, have now been recognized as being present at disease onset also in the ageing population, representing medical challenges different from those in the younger population. In the past years, knowledge on this special older population has increased, changing initial beliefs concerning epidemiology and course of disease. In the present review, we will address the most recent evidence concerning their current incidence compared with other age groups, their clinical course, potential risk factors for the development of late-onset IBDs, associated diseases, and cancer risk beyond therapy-related neoplasias.
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http://dx.doi.org/10.23736/S2724-5985.21.02890-4DOI Listing
May 2021

Knowledge of Diagnostic and Therapeutic Aspects of IBD Among Nurses Working in Digestive Endoscopy: A Nationwide Italian Survey.

Gastroenterol Nurs 2021 May-Jun 01;44(3):E59-E66

Daniele Napolitano, RN, is a research nurse and ibd-nurse, CEMAD Digestive Disease Center, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.

The importance of inflammatory bowel disease (IBD) dedicated nurses in endoscopy services is poorly explored. Non-IBD healthcare professionals who work in endoscopy units may underestimate the discomfort and the secondary psychological distress that endoscopic procedures cause in IBD patients. We performed a nationwide survey to evaluate the level of knowledge of nurses working in endoscopy facilities throughout Italy related to IBD patients' needs undergoing endoscopic procedures. A non-validate 45 items questionnaire divided into six sections was assembled by a group of experts and supervised by nurses and IBD-physicians as part of the board of IGIBD, ANOTE-ANIGEA and AGGEI. The questionnaire was sent to 397 nurses of which 335 (84.4%) responded to the questionnaire. The median level of knowledge registered was 29 ± 12, corresponding to a medium level of knowledge based on the scores described in the method section. One hundred eighty-three nurses (54.6%) reported a high score, 113 (33.7%) a medium score, and 39 (11.6%) a low score. The majority of nurses worked in high volume endoscopy centers, where the 48% were educated in IBD management. A Low level of knowledge was recorded regarding disease severity definition, bowel preparation strategies in severe colitis and evaluation of perianal fistula. This nationwide survey clearly shows that there is a need for endoscopic nurses to acquire specific knowledge in the IBD field. Dedicated pathways for IBD management in endoscopy, continuous educational programs for nurses and further studies to improve nurse education are needed.
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http://dx.doi.org/10.1097/SGA.0000000000000593DOI Listing
June 2020

At the Crossroads of Caution and Intervention: Anti-TNF Therapy Prior to Elective CD Surgery.

J Crohns Colitis 2021 Oct;15(10):1778-1779

Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy.

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http://dx.doi.org/10.1093/ecco-jcc/jjab092DOI Listing
October 2021

Rediscovering histology: what is new in endoscopy for inflammatory bowel disease?

Therap Adv Gastroenterol 2021 16;14:17562848211005692. Epub 2021 Apr 16.

IBD Center, Humanitas Clinical and Research Center, IRCCS, Via Manzoni 56, Rozzano, Milan, 20089, Italy.

The potential of endoscopic evaluation in the management of inflammatory bowel diseases (IBD) has undoubtedly grown over the last few years. When dealing with IBD patients, histological remission (HR) is now considered a desirable target along with symptomatic and endoscopic remission, due to its association with better long-term outcomes. Consequently, the ability of endoscopic techniques to reflect microscopic findings without having to collect biopsies has become of upmost importance. In this context, a more accurate evaluation of inflammatory disease activity and the detection of dysplasia represent two mainstay targets for IBD endoscopists. New diagnostic technologies have been developed, such as dye-less chromoendoscopy, endomicroscopy, and molecular imaging, but their real incorporation in daily practice is not yet well defined. Although dye-chromoendoscopy is still recommended as the gold standard approach in dysplasia surveillance, recent research questioned the superiority of this technique over new advanced dye-less modalities [narrow band imaging (NBI), Fuji intelligent color enhancement (FICE), i-scan, blue light imaging (BLI) and linked color imaging (LCI)]. The endoscopic armamentarium might also be enriched by new video capsule endoscopy for monitoring disease activity, and high expectations are placed on the application of artificial intelligence (AI) systems to reduce operator-subjectivity and inter-observer variability. The goal of this review is to provide an updated insight on contemporary knowledge regarding new endoscopic techniques and devices, with special focus on their role in the assessment of disease activity and colorectal cancer surveillance.
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http://dx.doi.org/10.1177/17562848211005692DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8053840PMC
April 2021

Predictive Value of Bowel Ultrasound in Crohn's Disease: A 12-Month Prospective Study.

Clin Gastroenterol Hepatol 2021 Apr 22. Epub 2021 Apr 22.

Istituti di Ricovero e Cura a Carattere Scientifico Humanitas Research Hospital, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.

Background & Aims: Mucosal healing is associated with better outcomes in Crohn's disease (CD). Colonoscopy is invasive and poorly tolerated. Bowel ultrasound (US) is a noninvasive tool that increasingly is being used for CD assessment. We assessed the predictive role of baseline bowel US findings on disease course in a large prospective cohort of CD patients for 12 months.

Methods: Ileocolonic CD consecutive patients were followed up for 12 months after performing bowel US. The negative course of CD, defined as the need for steroids and/or change of therapy and/or hospitalization and/or the need for surgery, was assessed. We evaluated this composite end point and subsequently considered each individual end point separately. Predictors of negative disease course were analyzed by logistic regression analysis.

Results: There were 225 ileal and/or colonic CD consecutive patients included in the study. We analyzed the association between baseline bowel US parameters and endoscopic activity (defined as a Simplified Endoscopic Activity score for CD > 2) to set up a noninvasive quantitative ultrasound-based score (bowel ultrasound score). The multivariable analysis identified the following independent predictors of a worse outcome throughout the 12-month period as follows: bowel ultrasound score greater than 3.52 (odds ratio [OR], 6.97; 95% CI, 2.87-16.93; P < .001), presence of at least 1 disease complication (stricture, fistula, abscess) at baseline bowel US (OR, 3.90; 95% CI, 1.21-12.53; P = .021), fecal calprotectin value of 250 μg/g or greater at baseline (OR, 5.43; 95% CI, 2.25-13.11; P < .001), and male sex (OR, 2.60; 95% CI, 1.12-6.02; P = .025).

Conclusions: Bowel US predicts the 12-month course in CD.
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http://dx.doi.org/10.1016/j.cgh.2021.04.029DOI Listing
April 2021

Inflammatory Bowel Disease in Migrant Populations: Should we Look Even Further Back?

Curr Drug Targets 2021 ;22(15):1706-1715

Clinical Pharmacology Unit, Sao Joao Hospital University Center, Porto, Portugal.

Background: The incidence of inflammatory bowel disease (IBD) continues to rise worldwide. Despite the advances in pharmacotherapy, the etiopathogenesis of Crohn's disease (CD) and ulcerative colitis (UC) remains underexplained. The migratory waves are a challenging setting to analyze the evolution of IBD prevalence and to infer its triggering factors.

Objective: Our study aimed to overview the literature regarding IBD prevalence and phenotype in first- and second-generation migrants Also, we aimed to summarize the migration history and to draw a possible correlation with IBD distribution.

Methods: A non-systematic review was performed following electronic (PubMed and Web of Science) and manual searches on relevant topics.

Results: Overall, first-generation migrants tend to maintain the IBD risk of the native country. On the following generation, the risk tends to converge to that of the destination country. Earlier age at migration modulates IBD risk, suggesting that the degree of exposure to environmental and socio-economic factors can be decisive for disease progression. In general, CD needs more time to reach a disease burden similar to that of the host country, indicating that UC may be more affected by nongenetic factors and genetic-nongenetic interactions.

Conclusion: IBD phenotypes and natural history vary in migrants and according to ethnicity; however, the trends are not consensual among cohorts. Further studies are warranted to analyze the effect of genetic background and environmental risk factors in different ethnic groups, providing evidence to move towards the identification of at-risk individuals, prevention, and earlier diagnosis of IBD.
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http://dx.doi.org/10.2174/1389450122666210203193817DOI Listing
January 2021

TL1A: A New Potential Target in the Treatment of Inflammatory Bowel Disease.

Curr Drug Targets 2021 ;22(7):760-769

Humanitas Clinical and Research Center - IRCCS -, via Manzoni 56, 20089 Rozzano (Mi), Italy.

Inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), are chronic inflammatory diseases of the gastrointestinal tract. In the last few years, the development of biological agents targeting cytokines and receptors involved in IBD pathogenesis has led to better outcomes and has improved the course of the disease. Despite their effectiveness, drugs such as tumor necrosis factor (TNF) inhibitors, anti-Interleukin-12/23 and anti-integrins, do not induce a response in about one-third of patients, and 40% of patients lose response over time. Therefore, more efficient therapies are required. Recent studies showed that TL1A (Tumor necrosis factor-like cytokine 1A) acts as a regulator of mucosal immunity and participates in immunological pathways involved in the IBD pathogenesis. In this review article, we analyze the role of TL1A as a new potential target therapy in IBD patients.
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http://dx.doi.org/10.2174/1389450122999210120205607DOI Listing
January 2021

Nursing-sensitive outcomes in adult inflammatory bowel disease: A systematic review.

J Adv Nurs 2021 May 10;77(5):2248-2266. Epub 2021 Jan 10.

Department of Clinical and Experimental Medicine, University "Magna Graecia", Catanzaro, Italy.

Aims: To evaluate nursing activity through outcomes that are affected, provided, and/or influenced by nurses and defined as nursing-sensitive outcomes in adult IBD patients.

Design: Systematic review without meta-analysis.

Data Sources: PubMed, Embase, CINAHL, PsycINFO, and the Cochrane Library databases on August 2019.

Review Methods: Peer-reviewed articles published between 2000-2020 were reviewed. The outcome measures were contextualized and presented by OMERACT Filter 2.0.

Results: Twenty-four studies were included. Eighteen nursing-sensitive outcomes were identified. These outcomes defined eight domains for health intervention, fitting into three core areas (resource use/economic impact, life impact, pathophysiological manifestations). Fifty-three measurement instruments were identified.

Conclusions: Through 53 measurement tools, with use of OMERACT framework, 18 nursing-sensitive outcomes in the main 3 core areas were identified, highlighting the multidimensional role of nursing. Further insights are to be carried out to define nursing outcomes included in IBD nursing intervention studies.

Impact: These results could serve as a cornerstone for further investigations and validation by a panel of experts to standardizing nursing activity in a multidisciplinary context.
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http://dx.doi.org/10.1111/jan.14744DOI Listing
May 2021

Milan ultrasound criteria are accurate in assessing disease activity in ulcerative colitis: external validation.

United European Gastroenterol J 2021 May 16;9(4):438-442. Epub 2021 Feb 16.

Department of Gastroenterology, Humanitas Clinical and Research Center - IRCCS, Milan, Italy.

Introduction: The aim of this study was to provide an external validation of bowel ultrasound (US) predictors of activity in ulcerative colitis (UC) and quantitative Milan Ultrasound Criteria (MUC).

Methods: Forty-three consecutive patients with UC (16 in endoscopic remission and 27 with endoscopic activity) underwent bowel US and colonoscopy in a tertiary referral inflammatory bowel disease unit.

Results: An MUC score >6.2 discriminated patients with active versus non-active UC with a sensitivity of 0.85 (95% confidence interval (CI) 0.66-0.96), specificity of 0.94 (95% CI 0.70-0.99) and an area under the curve of 0.902 (95% CI 0.772-0.971) in complete agreement with the derivation study.

Conclusion: The external validation of MUC confirms that it is an accurate tool for assessing disease activity in patients with UC.
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http://dx.doi.org/10.1177/2050640620980203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259285PMC
May 2021

New Paradigms to Help Decisions in Treatment Choice: Head to Head Trial of Biological Therapies in Inflammatory Bowel Diseases.

Curr Drug Targets 2021 ;22(4):370-378

Humanitas Clinical and Research Center - IRCCS- Via Manzoni 56, 20089, Rozzano, Milan, Italy.

The increasing armamentarium of drugs for inflammatory bowel disease (IBD) requires a direct comparison of different therapeutic options in order to guide physicians in the choice of the most appropriate treatment for their patients. Head-to-head trials, considered the gold standard in comparative research in IBD, allow to compare different therapies in the same population and setting, but also to evaluate different treatment strategies. Although head-to-head trials including biologics and immunosuppressive therapy in IBD have been performed decades ago, the interest in these direct comparisons is growing since the publication of the first randomized controlled trial directly comparing biologic agents with different molecular targets. This review provides an overview of the past and current IBD head-to-head trials, considering their respective strengths and limitations in a real-life setting.
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http://dx.doi.org/10.2174/1389450121666201211162527DOI Listing
January 2021

New drugs in the pipeline for the treatment of inflammatory bowel diseases: what is coming?

Curr Opin Pharmacol 2020 12 27;55:141-150. Epub 2020 Nov 27.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy. Electronic address:

Over the past twenty years several biological drugs and the first small molecule have been approved for the treatment of patients with inflammatory bowel diseases (IBD). However, a large percentage of patients do not respond to therapies and the demand for new effective drugs is still an unmet need. The better understanding of the pathophysiological mechanisms of disease has allowed to identify new therapeutic targets to block inflammatory pathways. To date, many emerging drugs have been developed and are being tested for both ulcerative colitis and Crohn's disease patients. Here, we summarize the efficacy and safety data of the most promising drugs that could soon enrich the therapeutic armamentarium of IBD patients.
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http://dx.doi.org/10.1016/j.coph.2020.10.015DOI Listing
December 2020

Application of Ultrasound Elastography for Assessing Intestinal Fibrosis in Inflammatory Bowel Disease: Fiction or Reality?

Curr Drug Targets 2021 ;22(3):347-355

Humanitas Clinical and Research Center - IRCCS -, via Manzoni 56, 20089 Rozzano (Mi), Italy.

Background: Intestinal fibrosis and subsequent strictures represent an important burden in inflammatory bowel disease (IBD). Both the detection and evaluation of the degree of fibrosis in stricturing Crohn's disease (CD) are important when deciding the best therapeutic strategy (medical anti-inflammatory therapy, endoscopic dilation, surgery). Ultrasound elastography (USE) is a non-invasive technique that has been proposed in the field of IBD for evaluating intestinal stiffness as a biomarker of intestinal fibrosis.

Objective: The aim of this review is to discuss the ability and current role of ultrasound elastography in the assessment of intestinal fibrosis.

Results And Conclusion: Data on USE in IBD are provided by pilot and proof-of-concept studies with small sample size. The first type of USE investigated was strain elastography, while shear wave elastography has been introduced recently. Despite the heterogeneity of the methods of the studies, USE has been proven to be able to assess intestinal fibrosis in patients with stricturing CD. However, before introducing this technique in current practice, further studies with larger sample sizes are needed. In addition, the use of homogeneous parameters, the assessment of reproducibility, and the identification of validated cut-off values are essential.
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http://dx.doi.org/10.2174/1389450121666201119142919DOI Listing
January 2021

Patients with Inflammatory Bowel Disease Are Not at Increased Risk of COVID-19: A Large Multinational Cohort Study.

J Clin Med 2020 Oct 31;9(11). Epub 2020 Oct 31.

Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090 Pieve Emanuele, Milan, Italy.

The impact of COVID-19 on inflammatory bowel disease (IBD) patients under pharmacological immunosuppression is still not clearly understood. We investigated the incidence of COVID-19 and the impact of immunosuppression and containment measures on the risk of SARS-CoV-2 infection in a large IBD cohort, from a multicenter cohort from 21st of February to 30th of June, 2020. Ninety-seven patients with IBD (43 UC, 53 CD, one unclassified IBD) and concomitant COVID-19 over a total of 23,879 patients with IBD were enrolled in the study. The cumulative incidence of SARS-CoV-2 infection in patients with IBD vs. the general population was 0.406% and 0.402% cases, respectively. Twenty-three patients (24%) were hospitalized, 21 (22%) had pneumonia, four (4%) were admitted to the Intensive Care Unit, and one patient died. Lethality in our cohort was 1% compared to 9% in the general population. At multivariable analysis, age > 65 years was associated with increased risk of pneumonia and hospitalization (OR 11.6, 95% CI 2.18-62.60; OR 5.1, 95% CI 1.10-23.86, respectively), treatment with corticosteroids increased the risk of hospitalization (OR 7.6, 95% CI 1.48-40.05), whereas monoclonal antibodies were associated with reduced risk of pneumonia and hospitalization (OR 0.1, 95% CI 0.04-0.52; OR 0.3, 95% CI 0.10-0.90, respectively). The risk of COVID-19 in patients with IBD is similar to the general population. National lockdown was effective in preventing infection in our cohort. Advanced age and treatment with corticosteroids impacted negatively on the outcome of COVID-19, whereas monoclonal antibodies did not seem to have a detrimental effect.
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http://dx.doi.org/10.3390/jcm9113533DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7693947PMC
October 2020

Activities related to inflammatory bowel disease management during and after the coronavirus disease 2019 lockdown in Italy: How to maintain standards of care.

United European Gastroenterol J 2020 12 18;8(10):1228-1235. Epub 2020 Oct 18.

Gastroenterology Unit, Mauriziano Hospital, Turin, Italy.

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.
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http://dx.doi.org/10.1177/2050640620964132DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7724532PMC
December 2020

Medical therapy versus surgery in moderate-to-severe ulcerative colitis.

Dig Liver Dis 2021 04 10;53(4):403-408. Epub 2020 Oct 10.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Division of Colon and Rectal Surgery, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy. Electronic address:

Ulcerative colitis, a chronic inflammatory condition that affects the colon from rectum to caecum, is characterized by periods of increased bowel movements, blood in feces, rectal urgency, tenesmus, and abdominal pain, with periods of remission and flares of disease, which negatively impact quality of life. A number of therapeutic options are available for patients with moderate-to-severe ulcerative colitis, however, no clear treatment algorithm exists. Therapeutic goals include short-term benefits for patients (i.e., the reduction/absence of symptoms, essentially stool frequency and rectal bleeding) and long-term benefits (i.e., sustained clinical remission, steroid-free remission, and mucosal healing). Therapies currently approved and available for the treatment of moderate-to-severe ulcerative colitis include monoclonal antibodies such as those targeting anti-tumor necrosis factor α (i.e., infliximab, adalimumab, golimumab), anti-adhesion molecules (i.e., vedolizumab), anti-interleukin 12/23 agents (i.e., ustekinumab), and Janus Kinase inhibitors (i.e., tofacitinib). Surgical approaches should also be considered in patients refractory to medical therapy or with complications (including toxic megacolon or colonic dysplasia/cancer). This review provides an overview of currently available treatment options for patients with moderate-to-severe ulcerative colitis and summarizes factors that should be considered during the therapeutic decision.
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http://dx.doi.org/10.1016/j.dld.2020.09.022DOI Listing
April 2021

Validation of the Red Flags Index for Early Diagnosis of Crohn's Disease: A Prospective Observational IG-IBD Study Among General Practitioners.

J Crohns Colitis 2020 Sep 28. Epub 2020 Sep 28.

Humanitas University, Biomedical Sciences, Pieve Emanuele, Italy.

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 negative for CD diagnosis.

Results: From November 2016 to November 2019, 112 patients were included. A total of 66 subjects [59%] completed the study after the first gastroenterological visit. The prevalence of CD was 3.6% in the study population [4/112]. The RF index had 50% sensitivity, 58% specificity, 4% PPV, and 97% NPV. A combined diagnostic strategy with faecal calprotectin [FC] [RFI ≥8 and/or FC >250 ng/g] resulted in significantly improved accuracy: sensitivity 100% [29-100%], specificity 72% [55-85%], PPV = 21% [5-51%], NPV = 100% [88-100%].

Conclusions: The RF Index combined with FC is a valid tool to identify patients with high probability of having CD at early stage.
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http://dx.doi.org/10.1093/ecco-jcc/jjaa111DOI Listing
September 2020

Inflammatory bowel disease course in liver transplant versus non-liver transplant patients for primary sclerosing cholangitis: LIVIBD, an IG-IBD study.

Dig Liver Dis 2021 Jun 21;53(6):712-716. Epub 2020 Sep 21.

Italian Group for the study of Inflammatory Bowel Disease IG-IBD, Florence, Italy.

Background: Data regarding the effect of orthotopic liver transplantation (OLT) for primary sclerosing cholangitis (PSC) on inflammatory bowel disease (IBD) course are scarce and conflicting.

Aims: To compare the incidence of refractory IBD in two groups (OLT and non-OLT) of patients affected by IBD and PSC.

Methods: An observational, multicentre, cohort retrospective study was conducted by the Italian Group for the study of IBD in Italy. The primary outcome was the need for biologic therapy or bowel resection for medically refractory IBD or hospitalization due to IBD relapse during the follow-up. Secondary outcomes were rate of colonic dysplasia, colorectal cancer, other solid tumours, lymphoma.

Results: Eighty-four patients were included in the study. The primary outcome was not different between OLT and non-OLT groups (11/27, 40.7%, versus 20/57, 35.1%, respectively, p = 0.62). The lymphoma and other tumours (thyroid cancer, kidney cancer, ileal tumour, ovarian cancer, cervical cancer) rates were significantly higher in the OLT group (p = 0.04 and p = 0.005, respectively), at the limit of statistical significance for high-grade colonic dysplasia (p = 0.06).

Conclusion: OLT in patients affected by IBD and PSC is not a risk factor for a more severe IBD course, but it is associated with a higher occurrence of cancer.
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http://dx.doi.org/10.1016/j.dld.2020.09.011DOI Listing
June 2021

Biosimilar switching in inflammatory bowel disease: from evidence to clinical practice.

Expert Rev Clin Immunol 2020 10 29;16(10):1019-1028. Epub 2020 Sep 29.

Department of Biomedical Sciences, Humanitas University , Milan, Italy.

Introduction: After patents' expiration of biological originators, several biosimilars of infliximab and adalimumab have been authorized. The approval is based on data extrapolated from other indications for which the originator has been previously tested. Despite rigorous approval processes by regulatory entities, physicians' and patients' knowledge about biosimilars is limited and some concerns about their use persist.

Areas Covered: This article summarizes the evidence on efficacy, safety, and immunogenicity of biosimilars currently approved in Europe for IBD treatment, by reviewing the literature on PubMed, EMBASE, and Web of Science databases up to mid-July 2020. Particular emphasis was placed on the need to further improve communication with patients and physicians' knowledge on biosimilars.

Expert Opinion: Adoption of biosimilars in clinical practice represents a great opportunity from an economic point of view, reducing healthcare costs and increasing patients' access to effective biologic treatments. Clinicians should be aware and confident of the latest evidence on available biosimilars and be very careful in communicating information to patients. Nocebo effect should not be overlooked since it can negatively influence outcomes of biosimilar-treated subjects, limiting the wide use of biosimilars. Evaluating the outcomes of reverse, multiple, and cross-switch will be a challenge for the next years.
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http://dx.doi.org/10.1080/1744666X.2021.1826311DOI Listing
October 2020

Key Strategies to Optimize Outcomes in Mild-to-Moderate Ulcerative Colitis.

J Clin Med 2020 Sep 8;9(9). Epub 2020 Sep 8.

Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20090 Milan, Italy.

Mesalamine (5-ASA) is the mainstay therapy in patients with mild-to-moderate active ulcerative colitis (UC). However, non-adherence to therapy and practice variability among gastroenterologists represent long-standing barriers, leading to poor outcomes. Additionally, targets to treat in UC are increasingly evolving from focusing on clinical remission to achieving endoscopic and histological healing. To date, systemic steroids are still recommended in non-responders to 5-ASA, despite their well-known side effects. Importantly, with the advent of new therapeutic options such as oral corticosteroids with topical activity (e.g., budesonide multimatrix system (MMX)), biologics, and small molecules, some issues need to be addressed for the optimal management of these patients in daily clinical practice. The specific positioning of these drugs in patients with mild-to-moderate disease remains unclear. This review aims to identify current challenges in clinical practice and to provide physicians with key strategies to optimize treatment of patients with mild-to-moderate UC, and ultimately achieve more ambitious therapeutic goals.
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http://dx.doi.org/10.3390/jcm9092905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564568PMC
September 2020

Thrombosis in IBD in the Era of JAK Inhibition.

Curr Drug Targets 2021 ;22(1):126-136

Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Patients with inflammatory bowel diseases (IBD) have an increased risk of thrombosis. The interaction between inflammation and coagulation has extensively been studied. It is well-- known that some drugs can influence the haemostatic system, but several concerns on the association between therapies and increased risk of thrombosis remain open. While biologics seem to have a protective role against thrombosis via their anti-inflammatory effect, some concerns about an increased risk of thrombosis with JAK inhibitors have been raised. We conducted a literature review to assess the association between biologics/small molecules and venous/arterial thrombotic complications. An increased risk of venous and arterial thrombosis was found in patients treated with corticosteroids, whereas anti-TNFα were considered protective agents. No thromboembolic adverse event was reported with vedolizumab and ustekinumab. In addition, thromboembolic events rarely occurred in patients with ulcerative colitis (UC) after therapy with tofacitinib. The overall risk of both venous and arterial thrombosis was not increased based on the available evidence. Finally, in the era of JAK inhibitors, the treatment should be individualized by evaluating the pre-existing potential thrombotic risk balanced with the intrinsic risk of the medication used.
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http://dx.doi.org/10.2174/1389450121666200902164240DOI Listing
January 2021

Absence of COVID-19 Infection in Patients Accessing IBD Unit at Humanitas, Milan: Implications for Postlockdown Measures.

Am J Gastroenterol 2020 10;115(10):1719-1721

IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy.

Introduction: The risk of coronavirus disease-19 infection for healthcare professionals and patients in hospitals remains unclear.

Methods: We investigated whether precautions adopted in our inflammatory bowel disease (IBD) unit have minimized the risks of infection for all patients accessing our facilities in a 1-month period by assessing the rate of coronavirus disease-19 infection in the follow-up period.

Results: Three hundred-twenty patients with IBD were included. None were infected from severe acute respiratory syndrome-coronavirus 2 in the follow-up period. None of the IBD team members were infected.

Discussion: Neither pharmacological immunosuppression nor access to the hospital seem to be risk factors for infection in patients with IBD.
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http://dx.doi.org/10.14309/ajg.0000000000000829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7499879PMC
October 2020

Endoscopy after surgery in inflammatory bowel disease: Crohn's disease recurrence and pouch surveillance.

Expert Rev Gastroenterol Hepatol 2020 Sep 18;14(9):829-841. Epub 2020 Aug 18.

IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center - IRCCS , Rozzano (Mi), Italy.

Introduction: Crohn's disease (CD) and ulcerative colitis (UC) are immune-mediated disorders characterized by a chronic inflammation, with intermittent exacerbations of symptoms and inflammation. In both diseases, medical treatment has made revolutionary steps forward. Nevertheless, surgery is still required in many cases due to inefficacy of multiple medical therapies. It is not clear whether surgery rates in inflammatory bowel diseases (IBD) are currently decreasing despite all improvements.

Areas Covered: Multidisciplinary management is critical in surgical patients to improve long-term outcomes. Endoscopy plays a crucial role, both before and after surgery, in planning therapeutic strategies and stratifying risk of recurrence. Aim of this review is to provide a deeper insight into the central role of endoscopy in the postoperative management of IBD patients, focusing on recent research advances, future challenges and unresolved questions.

Expert Opinion: Both UC and CD surgical patients need endoscopy to define the correct therapeutic choice, predict subsequent disease course and adopt the correct surveillance strategy. In the next future, newer endoscopic techniques could be systematically applied in IBD patients after surgery, to assess early postoperative inflammation, response to treatment, or, regarding UC, to provide enhanced pouch surveillance, allowing for early detection of inflammation and dysplasia.
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http://dx.doi.org/10.1080/17474124.2020.1807325DOI Listing
September 2020
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