Publications by authors named "Paolo Gionchetti"

106 Publications

An expert consensus to standardise clinical, endoscopic and histologic items and inclusion and outcome criteria for evaluation of pouchitis disease activity in clinical trials.

Aliment Pharmacol Ther 2021 Mar 18. Epub 2021 Mar 18.

London, ON, Canada.

Background: Pouchitis is a condition with large unmet medical needs and no approved therapies. Lack of validated instruments to measure disease activity and treatment response is a major barrier to drug development.

Aim: To conduct a modified RAND/University of California Los Angeles appropriateness process to produce a standardised assessment of pouchitis disease activity in clinical trials.

Methods: A list of 164 items generated upon a systematic review and expert opinion were rated based on a 9-point scale (appropriate, uncertain and inappropriate), by a panel including 16 gastroenterologists, surgeons and histopathologists.

Results: Items rated as appropriate to evaluate in pouchitis clinical trials were: (a) clinical: stool frequency and faecal urgency; (b) endoscopic: primary assessment in the pouch body according to the percentage of affected area (<50%, 50%-75% and >75%), evaluation of the presence of ulcers/erosions according to size (erosions <5 mm, ulcers ≥5 mm to 2 cm and large ulcers >2 cm) and ulcerated area (<10%, 10%-30% and >30%); (c) histologic: two biopsies from each segment, from the ulcer's edge when present, or endoscopically normal areas, assessment of lamina propria chronic inflammation, epithelial and lamina propria neutrophils, epithelial damage, erosions and ulcers; and (d) clinical trial inclusion/outcome criteria: minimum histologic disease activity for inclusion, a primary endpoint based on stool frequency and assessment of clinical, endoscopic and histologic response and remission. The overall majority of items surveyed (100/164) were rated 'uncertain'.

Conclusion: We conducted a RAND/UCLA appropriateness process to help inform measurement of pouchitis disease activity within clinical trials and foster the development of novel therapies.
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http://dx.doi.org/10.1111/apt.16328DOI Listing
March 2021

COVID-19 in IBD: The experience of a single tertiary IBD center.

Dig Liver Dis 2021 03 26;53(3):271-276. Epub 2020 Dec 26.

Centro di Riferimento Regionale Malattie Infiammatorie Croniche Intestinali, DIMEC Azienda Ospedaliero-Universitaria Policlinico Sant'Orsola-Malpighi, Bologna, Italy. Electronic address:

Background: Italy has been one of the most affected countries in the world by COVID-19. There has been increasing concern regarding the impact of COVID-19 on patients with inflammatory bowel disease (IBD), particularly in patients treated with immunosuppressants or biologics. The aim of our study is to understand the incidence of COVID-19 in a large cohort of patients with IBD. Furthermore, we analyzed possible risk factors for infection and severity of COVID-19.

Methods: This was an observational study evaluating the impact of COVID-19 on IBD patients in a single tertiary center. A 23 multiple-choice-question anonymous survey was administered to 1200 patients with IBD between March 10th and June 10th 2020.

Results: 1158 questionnaires were analyzed. The majority of patients had Crohn's disease (CD) (60%) and most of them were in clinical remission. Among the 26 patients (2.2%) who tested positive for COVID-19, only 5 (3CD) were on biological treatment and none required hospitalization. Two patients died and were on treatment with mesalazine only. Of the 1158 patients, 521 were on biological therapy, which was discontinued in 85 (16.3%) and delayed in 195 patients (37.4%). A worsening of IBD symptoms was observed in 200 patients on biological therapy (38.4%). Most of these patients, 189 (94.5%), had stopped or delayed biological treatment, while 11 (5.5%) had continued their therapy regularly (p<0.001).

Conclusions: Our data are in line with the current literature and confirm a higher incidence compared to the general population. Biological therapy for IBD seems to not be a risk factor for infection and should not be discontinued in order to avoid IBD relapse.
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http://dx.doi.org/10.1016/j.dld.2020.12.012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7764386PMC
March 2021

Ustekinumab for treating ulcerative colitis: an expert opinion.

Expert Opin Biol Ther 2020 11 24;20(11):1321-1329. Epub 2020 Jul 24.

IBD UNIT AO, "Villa Sofia-Cervello" Hospital , Palermo, Italy.

Introduction: Biologic agents have revolutionized the therapeutic management of ulcerative colitis. Anti-tumor necrosis factor agents were the first biologic drugs used to induce and maintain remission in this inflammatory bowel disease. Recently, another biologic option, ustekinumab, has become available for the treatment of moderate-to-severe ulcerative colitis.

Areas Covered: In this article, the authors review the literature on the efficacy and safety of ustekinumab in the context of current biologic agents used for the management of this disease. The potential role of ustekinumab in the treatment paradigm of the disease is also discussed. : The UNIFI trial has demonstrated the efficacy and safety of ustekinumab in induction and maintenance phases of treatment for ulcerative colitis. Ustekinumab may provide clinical benefit in a range of settings in patients with ulcerative colitis, even for those with multiple treatment failures, which are relatively common in daily clinical practice. Future clinical trials should compare the efficacy of ustekinumab with existing biologic agents in the management of ulcerative colitis.
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http://dx.doi.org/10.1080/14712598.2020.1792882DOI Listing
November 2020

Long term remission after ileorectal anastomosis in Crohn's colitis.

Dig Liver Dis 2020 Jun 29. Epub 2020 Jun 29.

IBD Unit, Department of Medical and Surgical Science, Sant'Orsola-Malpighi Hospital -University of Bologna, via Massarenti 9, 40138 Bologna, Italy. Electronic address:

Background: Crohn's disease represents a heterogeneous entity, but its location tends to be relatively stable overtime. For extensive refractory Crohn's colitis, ileorectal anastomosis after colectomy is an engaging option, since the necessity of a permanent ileostomy is avoided.

Aims: In our study, the long-term outcome of two groups of patients with Crohn's colitis who underwent colectomy and ileorectal anastomosis was compared. The first group had isolated colonic Crohn's disease without rectal involvement and perianal disease, while the second group included patients who had rectal and/or ileal involvement, with or without perianal disease.

Methods: Between 1996 and 2016, in a single IBD tertiary center, 80 patients with a history of colectomy and ileorectal anastomosis for refractory Crohn's colitis were retrospectively identified.

Results: Recurrence of disease was diagnosed in 57/64 of patients with Crohn's colitis with rectal and/or ileal and/or perianal involvement compared with 1/16 of patients with isolated Crohn's colitis without rectal and perianal disease in a median time of recurrence of 2 years (IQR 1-6 years, minimum to maximum, 1-18 years, p < 0.001). Only 6 patients (7,5%) underwent definitive end ileostomy without proctectomy (1 in the noIRP group and 5 in the IRP group).

Conclusion: Our data suggest that colectomy with ileorectal anastomosis may represent a curative option in patients with refractory isolated colitis without rectal and perianal involvement.
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http://dx.doi.org/10.1016/j.dld.2020.06.021DOI Listing
June 2020

Aortic Stiffening Is an Extraintestinal Manifestation of Inflammatory Bowel Disease: Review of the Literature and Expert Panel Statement.

Angiology 2020 09 15;71(8):689-697. Epub 2020 Apr 15.

INSERM U970, Department of Pharmacology, Paris, France.

Current guidelines state that systemic inflammation, together with endothelial dysfunction, calcification, and hypercoagulability, predispose to premature atherosclerosis in patients with inflammatory bowel disease (IBD). We assessed whether IBD can affect aortic stiffness, a well-recognized vascular biomarker and an independent risk factor for cardiovascular (CV) disease (CVD) in several populations. Recent studies reported that aortic stiffness is increased in adults with IBD compared with matched controls. This association is dependent on inflammatory burden and disease duration, and is reduced by antitumor necrosis factor therapy. Considered together, current findings suggest that increased aortic stiffness is an extraintestinal manifestation of IBD. This is clinically relevant since measuring aortic stiffness in patients with IBD could improve risk assessment, especially in those without established CVD. Moreover, effective control of inflammation could lower CV risk in patients with IBD by reducing aortic stiffness. Further longitudinal studies are needed to better clarify (i) the relationship between disease duration and irreversible changes of the arterial wall, (ii) the clinical characteristics of patients with IBD that have an increased arterial stiffness at least in part reversible, and (iii) whether arterial stiffness is useful to evaluate the efficacy of immunosuppressive therapy.
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http://dx.doi.org/10.1177/0003319720918509DOI Listing
September 2020

Usefulness of panoramic 344°-viewing in Crohn's disease capsule endoscopy: a proof of concept pilot study with the novel PillCam™ Crohn's system.

BMC Gastroenterol 2020 Apr 7;20(1):97. Epub 2020 Apr 7.

IBD Unit, Department of Medical and Surgical Sciences (DIMEC), Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy.

Background: A new capsule endoscopy (CE) system featuring two advanced optics for 344°-viewing and a prolonged operative time has been recently developed for Crohn's disease (CD) patients. Hence, we evaluated, for the first time, the performance of this novel CE and the add-on value of the 344°-viewing in a multi-center real-life setting.

Methods: Consecutive patients with suspected or established CD received the PillCam™ Crohn's System as supplementary diagnostic work-up focused on the small-bowel between June 2017 and June 2018. Technical and clinical data, including the panenteric CE diagnostic yield, the Lewis score and the impact of small-bowel findings on clinical management during a 6-months follow-up (new diagnosis, staging or treatment upgrade) were collected, thereby evaluating the added value of the 344° panoramic-view (lesions detected by camera A and B) over the standard 172°-view (lesions detected by one camera only).

Results: Among 41 patients (aged 43 ± 20 years), 73% underwent CE for suspected CD and 27% for established CD. The rate of complete enteroscopy was 90%. No technical failure or retention occurred. Compared to the standard 172° view, the panoramic 344°-view revealed a greater number of patients with a relevant lesion (56.1% vs. 39.0%; P = 0.023), resulting in higher Lewis score (222,8 vs. 185.7; P = 0.031), and improved clinical management (48.8% vs. 31.7%, P = 0.023).

Conclusions: The panoramic 344°-view increases small-bowel CE accuracy, thereby improving the clinical management of CD patients with mild small-bowel active disease. This system should be regarded as a new standard for both small-bowel diagnosis and monitoring in inflammatory bowel diseases.
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http://dx.doi.org/10.1186/s12876-020-01231-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7140388PMC
April 2020

Management of patients with complex perianal fistulas in Crohn's disease: Optimal patient flow in the Italian clinical reality.

Dig Liver Dis 2020 05 31;52(5):506-515. Epub 2019 Dec 31.

Digestive Surgery Department, S. Orsola-Malpighi University Hospital, Bologna, Italy.

Perianal fistulizing Crohn's disease (PFCD) is a common, disabling and aggressive phenotype that negatively impacts on the quality of life of affected patients. Its successful treatment is still a struggle for both physicians and patients. Significant advances in the management of this condition have occurred in the last two decades holding promise for a better future. This culminated into the concept of a collaborative multidisciplinary approach using the latest medical therapies combined with modern surgical and endoscopic techniques. Despite this, PFCD management and treatment have not been standardized yet. Thus the gastroenterologist and surgeon have to be familiar with several approaches and/or techniques. The positioning of each therapeutic option will certainly evolve with new data, but for the time being it should be driven by patient's characteristics, physician's preference and/or experience, costs and availability in local practice. Additionally, patient's perception of benefits and risks of treatment may differ from those of physicians and recognition of this difference is a starting point for difficult clinical decision-making. In this paper, a multidisciplinary group of Italian IBD experts explore and discuss current medical and surgical therapeutic options, highlighting areas of unmet needs in PFCD, with particular focus on the optimal patient flow within the Italian clinical reality.
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http://dx.doi.org/10.1016/j.dld.2019.11.016DOI Listing
May 2020

ECCO Guidelines on Therapeutics in Crohn's Disease: Surgical Treatment.

J Crohns Colitis 2020 Feb;14(2):155-168

Department of Surgery, Shamir Medical Center [Assaf Harofe], Tel Aviv, Israel.

This article is the second in a series of two publications relating to the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the management of Crohn's disease. The first article covers medical management; the present article addresses surgical management, including preoperative aspects and drug management before surgery. It also provides technical advice for a variety of common clinical situations. Both articles together represent the evidence-based recommendations of the ECCO for Crohn's disease and an update of previous guidelines.
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http://dx.doi.org/10.1093/ecco-jcc/jjz187DOI Listing
February 2020

Unmet Medical Needs in the Management of Ulcerative Colitis: Results of an Italian Delphi Consensus.

Gastroenterol Res Pract 2019 2;2019:3108025. Epub 2019 Sep 2.

IBD Unit, Department of Medicine and Surgery (DIMEC), University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.

Background: The lifelong and remitting nature of ulcerative colitis results in considerable disability and a substantial negative impact on quality of life. The major goal of the therapy of ulcerative colitis is considered to be the modification of the course of the disease, so that the patient's quality of life can be improved while minimising disease-related disability. Although considerable progress in understanding the molecular pathways involved in ulcerative colitis has led to improved treatment options, there is currently no definitive cure for ulcerative colitis, there remain considerable unmet needs in terms of long-term efficacy and safety, and there are many patients who continue to be burdened by physical and psychological symptoms. Defining unmet needs can help to increase the awareness of the shortcomings of current therapeutic management and highlight the need to achieve not only a control of clinical symptoms but also control of mucosal healing, in order to attain the best possible long-term outcomes.

Methods: With the aim of providing a better understanding of the unmet needs of patients towards improving overall care, a Delphi process was used to obtain consensus among a group of Italian ulcerative colitis experts. The consensus group met with a major focus of delineating the unmet needs of current treatment strategies and overall management of ulcerative colitis, while also focusing on quality of life and patient care.

Results: Three main areas were identified: (i) treatment, (ii) monitoring and risk management, and (iii) patient-related issues. A high level of consensus was reached on all but one of the statements identified.

Conclusions: The findings arising from the Delphi process provide valuable insights into the unmet needs in the management of moderate-to-severe ulcerative colitis from the clinician's perspective, while emphasising the benefits of therapeutic individualization and suggesting areas that need additional study with the aim of optimising the treatment of patients with ulcerative colitis.
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http://dx.doi.org/10.1155/2019/3108025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6745180PMC
September 2019

Refractory Complex Crohn's Perianal Fistulas: A Role for Autologous Microfragmented Adipose Tissue Injection.

Inflamm Bowel Dis 2020 01;26(2):321-330

Surgery of the Alimentary Tract, S. Orsola-Malpighi Hospital and Department of Medical and Surgical Sciences University of Bologna, Bologna, Italy.

Background: Complex perianal fistulas represent one of the most challenging manifestations of Crohn's disease. Combined surgical and medical therapy with biologic drugs today represent the first-line treatment option, but its efficacy does not exceed 60%. Recently, new therapeutic approaches, such as the use of mesenchymal stromal cells, have shown promising results. The adipose tissue is an abundant and easy to access source. The effectiveness, safety, and feasibility of local injections of microfragmented adipose tissue in patients with refractory complex fistulizing perianal Crohn's disease (PCD) were evaluated.

Methods: Fifteen patients with persistent complex fistulizing PCD after biosurgical approach and subsequent surgical "rescue" repair were treated in S. Orsola-Malpighi Hospital with a single-local administration of microfragmented adipose tissue prepared using a minimal manipulation technique (Lipogems) in a closed system. Clinical outcomes were determined at 24-week follow-ups assessing success rate, defined as combined clinical and radiological remission.

Results: Upon clinical examination at 24 weeks, 10 patients had combined remission (clinical and radiographic), 4 patients showed improvements, and 1 patient failed. The results were confirmed in all patients by pelvic MRI. No relevant postoperative complications nor adverse events were reported.

Conclusion: These results suggest that the local injection of autologous microfragmented adipose tissue is a safe and promising "rescue therapy" for patients with multiresistant complex fistulizing PCD. This approach might be proposed as routine because it is affordable, is minimally invasive, has no risk of sphincteric damage, and can be carried out in a day-surgery setting.
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http://dx.doi.org/10.1093/ibd/izz051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6943693PMC
January 2020

Budesonide MMX: efficacy and safety profile in the treatment of ulcerative colitis.

Expert Rev Gastroenterol Hepatol 2019 Jul 30;13(7):607-613. Epub 2019 May 30.

a IBD unit, Department of Internal Medicine and Gastroenterology , University of Bologna , Bologna , Italy.

: Ulcerative colitis is an idiopathic, chronic inflammatory disease of the colonic mucosa. Its clinical course is unpredictable, marked by alternating periods of exacerbation and remission. Traditional oral corticosteroids are still the mainstay treatment for the induction of ulcerative colitis remission in patients failing or intolerant to aminosalicylates, but the risk of side effects and complications limits their usefulness. Based on these considerations, new steroids with low systemic bioavailability, such as Beclomethasone dipropionate and Budesonide, have been developed. : We reviewed the current literature about the efficacy, safety and the role of budesonide MMX in the treatment of ulcerative colitis. The evidence reviewed in this article is a summation of relevant scientific publications, expert opinion statements, and current practice guidelines. : Budesonide MMX is a novel formulation that uses a Multi-Matrix System (MMX) technology to facilitate the release of high concentrations of active drug into the colon. Budesonide MMX at the dose of 9 mg/day for 8 weeks is effective and safe in inducing clinical and endoscopic remission in patients with mild to moderate UC, who had an inadequate response or were intolerant to either first line conventional therapy with topical and oral 5-aminosalicylic acid.
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http://dx.doi.org/10.1080/17474124.2019.1621745DOI Listing
July 2019

Implications of the Westernized Diet in the Onset and Progression of IBD.

Nutrients 2019 May 8;11(5). Epub 2019 May 8.

Department of Medical and Surgical Sciences, University of Bologna, Via Massarenti 9, 40138 Bologna, Italy.

Inflammatory bowel diseases (IBD) are currently considered multifactorial pathologies in which various combined environmental factors act on a genetic background, giving rise to a chronic inflammation of the gastrointestinal tract. Among the various environmental factors, it now seems clear that the diet plays the major role in IBD onset and progression. Several clinical studies have attempted to understand the impact of diet in the development and progression of these diseases in order to establish useful guidelines for their management. However, the modest and sometimes contradictory results did not lead to the definition of shared dietary suggestions. On the other hand, food fads and recommendations based on anecdotal episodes are often followed by IBD patients to improve their diet. This review provides a critical overview of existing data on the role of diet as a risk factor for IBD. The methodology used was that of analyzing the results of clinical studies conducted on diet and IBD over the last 12 years through PubMed, as well as analyzing the most relevant studies on nutrients and their possible roles in IBD through the knowledge of the mechanisms by which they can modulate the microbiota or the intestinal physiology.
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http://dx.doi.org/10.3390/nu11051033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6566788PMC
May 2019

A current overview of corticosteroid use in active ulcerative colitis.

Expert Rev Gastroenterol Hepatol 2019 Jun 22;13(6):557-561. Epub 2019 Apr 22.

a Department of Internal Medicine and Gastroenterology , University of Bologna , Bologna , Italy.

Introduction: Ulcerative colitis (UC) is a chronic inflammatory condition that causes continuous mucosal inflammation of the colon. New biological drugs have been developed in order to avoid colectomy, but corticosteroids still play a crucial role in management of active UC. Areas covered: We reviewed the current literature about the importance of corticosteroid use in the treatment of ulcerative colitis. The evidence reviewed in this article is a summation of relevant scientific publications, expert opinion statements, and current practice guidelines. This review is a summary of expert opinion in the field without a formal systematic review of evidence. Expert opinion: Corticosteroids represent the mainstay of treatment in patients with severe UC and are very effective in inducing remission in mild to moderate flares not responding to combined oral and topical mesalazine. A valid alternative to systemic corticosteroids is represented by poorly absorbed steroids, such as Beclomethasone dipropionate and Budesonide MMX. In mild-moderate distal disease topical administration of corticosteroids (both systemic and BDP) is an effective alternative to topical mesalazine. However, corticosteroids do not represent a therapeutic option as a maintenance treatment since they are associated with multiple adverse effects.
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http://dx.doi.org/10.1080/17474124.2019.1604219DOI Listing
June 2019

Risk factors and timing for colectomy in chronically active refractory ulcerative colitis: A systematic review.

Dig Liver Dis 2019 05 6;51(5):613-620. Epub 2019 Feb 6.

IBD Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy.

Background: In patients with chronic refractory ulcerative colitis (UC) the precise timing for indication to colectomy is unclear.

Aims: We performed a systematic review of the literature on the risk factors for colectomy in patients with chronic refractory UC in the biologic era.

Methods: PubMed Central/Medline and Embase were systemically searched for records published between January 2000 and December 2017. Current evidence was summarized and filtered by expert opinion.

Results: 70 studies were included in the qualitative synthesis. Several factors were found to be associated with a higher or reduced risk for colectomy, including variables at baseline - such as progression from proctitis/left-sided to extensive colitis, extensive colitis at diagnosis, high baseline C Reactive Protein or erythrocyte sedimentation rate, male gender, and younger age at diagnosis - previous medical history, and factors arising during therapy with biologics, including the absence of clinical response after induction with infliximab or adalimumab, and the lack of mucosal healing during therapy with anti-TNFs.

Conclusions: Two main points may help physicians to decide when the surgical option may be considered in patients with chronic refractory UC: (1) a first risk stratification can be obtained by analyzing factors at baseline and medical history, including the previous exposure to anti-TNFs; (2) during therapy with biologics, the early assessment (after 12-16 weeks of treatment) of clinical and endoscopic response is a strong predictor of the subsequent risk of colectomy.
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http://dx.doi.org/10.1016/j.dld.2019.01.018DOI Listing
May 2019

Predictors of early recurrence after strictureplasty for Crohn's disease of the small bowel during the years of biologics.

Dig Liver Dis 2019 05 8;51(5):663-668. Epub 2018 Dec 8.

Surgery of the Alimentary Tract, Department of Medical and Surgical Sciences, Sant'Orsola - Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.

Background: The identification of patients prone to early recurrence of Crohn's disease at the site of a strictureplasty is fundamental in the clinical practice.

Aims: Aim of the study is to detect the risk factors for early reoperation for recurrence after primary strictureplasty.

Methods: From 2000, patients undergoing a primary strictureplasty and a subsequent reoperation for recurrence of Crohn's disease at the site of a strictureplasty were included. Univariate and multivariable linear regression models were performed to analyse the relationship between the time to recurrence and independent variables.

Results: Fifty-nine patients were included. Median time to recurrence was 4.5 years (0.7-12.6). At the multivariate linear regression, early relapse was significantly associated with use of biologics before primary surgery (-2.69, p < 0.0001) and location of disease in the ileum (-1.61, p 0.017). The use of biologics after surgery was similar between groups (40.7 vs 37.5%, p 0.79).

Conclusions: The location of Crohn's disease in the ileum and the use of biologics before surgery are strong predictors of early site-specific recurrence after strictureplasty. In this group of patients, a tailored follow-up and aggressive postoperative treatment should be considered.
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http://dx.doi.org/10.1016/j.dld.2018.11.027DOI Listing
May 2019

The safety of beclomethasone dipropionate in the treatment of ulcerative colitis.

Expert Opin Drug Saf 2018 Sep 21;17(9):963-969. Epub 2018 Aug 21.

a Department of Medicine and Surgery (DIMEC), IBD unit, S. Orsola-Malpighi Hospital , University of Bologna , Bologna , Italy.

Introduction: Beclomethasone dipropionate (BDP) is a second-generation corticosteroid that uses novel drug technologies to ensure colonic targeting and potentially reducing systemic corticosteroid concentrations. It is approved for treatment of patients with mild-to-moderate ulcerative colitis (UC) who do not respond to mesalazine. The gut-selective mechanism of action has the potential to improve the safety profile of BDP compared with other conventional corticosteroids. Areas covered: We reviewed the mechanism of action, efficacy, and safety of BDP in the treatment of UC. The positioning of BDP in management algorithms is also discussed. Expert opinion: The highly selective mechanism of action of BDP restricts the steroid-related side effects. BDP is efficacious in the treatment of active UC. Topical formulation is the first choice in distal UC, while oral formulation is used in patients with an extensive involvement of the colon. The rates of adverse events (AE), serious AEs, and steroid-related side-effects are similar to placebo and mesalamine and slightly inferior to traditional corticosteroids.
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http://dx.doi.org/10.1080/14740338.2018.1510914DOI Listing
September 2018

Quality of Care in Ulcerative Colitis: A Modified Delphi Panel Approach.

Dig Dis 2018 3;36(5):346-353. Epub 2018 Jul 3.

Center for Observational and Real-World Evidence (CORE), Merck & Co., Inc., Kenilworth, New Jersey, USA.

Objectives: To establish clinical consensus on important and relevant quality-of-care (QoC) attributes in ulcerative colitis (UC) treatment that may improve treatment outcomes and guide best practices.

Methods: Thirty-eight QoC attributes were identified in a literature review. Sixteen European-based experts were selected based on their contributions to UC guidelines, publications, and patient care. A 3-round, modified Delphi panel was conducted including an interview round, and 2 web-based rounds to reach consensus and finalize a QoC attribute list.

Results: The draft QoC attribute list derived from a literature review and Round 1, expert interviews, comprised 63 attributes. In Rounds 2 and 3, the QoC attributes frequently rated as critically important were diagnosis (n = 15, 93.8%), treatment adherence (n = 15, 93.8%), and access to care/treatment (Round 2: n = 14, 87.5%; Round 3: n = 15, 93.8%). The final QoC attribute list consisted of 61 attributes across 20 domains, with the most attributes reported in the "treatment goals" domain (n = 9).

Conclusion: QoC is a complex and evolving concept that can improve outcomes while maximizing healthcare resources. Limited time and resources hamper clinicians' ability to openly and empathetically communicate with patients; novel technology may help to offer solutions.
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http://dx.doi.org/10.1159/000489845DOI Listing
August 2018

Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis.

Gastrointest Endosc 2018 08 13;88(2):360-369.e2. Epub 2018 Apr 13.

Robarts Clinical Trials Inc, London, Ontario, Canada; Department of Epidemiology and Biostatistics, University of Western Ontario, London, Ontario, Canada; Department of Medicine, University of Western Ontario, London, Ontario, Canada.

Background And Aims: Pouchitis is a common adverse event after proctocolectomy with ileal pouch anal anastomosis for ulcerative colitis. Evaluation of pouchitis disease activity and response to treatment requires use of validated indices. We assessed the reliability of items evaluating endoscopic pouchitis disease activity.

Methods: Twelve panelists used a modified RAND appropriateness methodology to rate the appropriateness of items evaluating endoscopic pouchitis disease activity derived from a systematic review and also identified additional potential endoscopic items based on expert opinion. Four central readers then evaluated 50 pouchoscopy videos in triplicate, in random order. Intra- and inter-rater reliability for each item was assessed by calculating and comparing intraclass correlation coefficients (ICCs). A Delphi process identified common sources of disagreement among the readers.

Results: Ten existing endoscopic items were identified from the systematic review and an additional 7 exploratory items from the panelists. ICCs for inter-rater reliability were highest for the existing item of pouch ulceration (.72; 95% confidence interval [CI], .60-.82) and for the exploratory item of ulcerated surface in the pouch body (.67; 95% CI, .53-.75). Inter-rater reliability for all other existing and exploratory items was "moderate" (ICC < .60). The item "ulcerated surface in the pouch body" demonstrated the best correlation with a global evaluation of lesion severity (r = .80; 95% CI, .73-.85).

Conclusion: Substantial reliability was observed only for the endoscopic items of ulceration and ulcerated surface in the pouch body. Future studies should assess responsiveness to treatment in the next stage toward development of an endoscopic pouchitis disease activity index.
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http://dx.doi.org/10.1016/j.gie.2018.04.2330DOI Listing
August 2018

Ustekinumab in the management of Crohn's disease: Expert opinion.

Dig Liver Dis 2018 07 11;50(7):653-660. Epub 2018 Mar 11.

Gastroenterology Unit, Mauriziano Hospital, Turin, Italy.

This expert-opinion paper reviews available evidence for the use of ustekinumab, a human interleukin 12/23 monoclonal antibody, in the treatment of Crohn's disease and discusses its potential role in the current treatment scenario for the condition. Ustekinumab appears to be associated with rapid and sustained clinical effect, as reported from the clinical research program, with additional support for potential mucosal healing. These characteristics are paralleled by a favorable safety profile, lack of immunogenicity and the presence of systemic anti-inflammatory activity. Importantly, ustekinumab requires only one single intravenous administration, while subsequent dosing is administered subcutaneously, with potential advantages for home-based therapy. Lastly, the dosage of ustekinumab is flexible. On the basis of the evidence, ustekinumab has a role in patients with primary failure or secondary loss of response to anti-tumor necrosis factor agents, as well as in those who have adverse events on front-line biologics or are reinitiating therapy after a treatment holiday. Current evidence suggests that ustekinumab may be particularly suitable in patients who present extra-intestinal manifestations of the disease or are at risk of infections. Ustekinumab may also be considered in the first-line setting, especially in frail patients, in young subjects or in those who have concomitant immune-mediated diseases.
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http://dx.doi.org/10.1016/j.dld.2018.02.017DOI Listing
July 2018

Multidisciplinary Management of Spondyloarthritis-Related Immune-Mediated Inflammatory Disease.

Adv Ther 2018 04 7;35(4):545-562. Epub 2018 Mar 7.

Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.

Introduction: Immune-mediated inflammatory diseases (IMIDs) are chronic autoimmune conditions that share common pathophysiologic mechanisms. The optimal management of patients with IMIDs remains challenging because the coexistence of different conditions requires the intervention of several specialists. The aim of this study was to develop a series of statements defining overarching principles that guide the implementation of a multidisciplinary approach for the management of spondyloarthritis (SpA)-related IMIDs including SpA, psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis and uveitis.

Methods: A Delphi consensus-based approach was used to identify a core set of statements. The process included development of initial questions by a steering committee, an exhaustive search of the literature using complementary approaches to identify potential statements and two Delphi voting rounds for finalization of the statements.

Results: Consensus was achieved on the related nature of IMIDs, the existence of a high prevalence of multiple IMIDs in a single patient and the fact that a multidisciplinary approach can result in a more extensive evaluation and comprehensive approach to treatment. The goals of a multidisciplinary team should be to increase diagnosis of concomitant IMIDs, improve the decision-making process, and increase patient satisfaction and adherence. Early referral and diagnosis, early recognition of concomitant IMIDs and optimizing treatment to improve patient quality of life are some of the advantages of using multidisciplinary teams. To be effective, a multidisciplinary team should be equipped with the appropriate tools for diagnosis and follow-up, and at a minimum the multidisciplinary team should include a dermatologist, gastroenterologist and rheumatologist; providing psychologic support via a psychologist and involving an ophthalmologist, general practitioners and nurses in multidisciplinary care is also important.

Conclusion: The present Delphi consensus identified a set of overarching principles that may be useful for implementation of a multidisciplinary approach for the management of SpA-related IMIDs.

Funding: Aristea and Hippocrates.
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http://dx.doi.org/10.1007/s12325-018-0672-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5910456PMC
April 2018

Prepouch Ileitis After Ileal Pouch-anal Anastomosis: Patterns of Presentation and Risk Factors for Failure of Treatment.

J Crohns Colitis 2018 Feb;12(3):273-279

Surgery of the Alimentary Tract, Department of Medical and Surgical Sciences, Sant'Orsola - Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.

Background And Aims: There is a lack in the literature about prepouch ileitis [PI], in particular regarding risk factors associated with failure of the medical treatment. Aim of the study is to analyse the characteristics of PI patients and to compare those who required surgery with those who were successfully treated with conservative therapy.

Methods: All cases presenting a diagnosis of PI were included and analysed. Patients eventually requiring surgery were compared with those who were managed conservatively, for symptoms of presentation, endoscopic characteristics, and rate of response to medical treatment. A sub-analysis of outcomes based on the final histology was performed.

Results: The overall incidence of PI among 1286 patients was 4.4% [57], after a median of 6.8 years from pouch surgery. Symptoms included increased frequency [26.4%], outlet obstruction [21%], and bleeding [15.8%]. Afferent limb stenosis affected 49.1% of patients. The comparison showed that patients requiring surgery had a higher rate of Crohn's disease and indeterminate colitis [42.1 vs 0% and 15.8 vs 2.6%, p < 0.0001], outlet obstruction as main symptom [47.4 vs 7.9%, p = 0.0023], and afferent limb stenosis [73.7 vs 36.8%, p = 0.008] at endoscopy. Rate of failure of medical treatment at 5 years was 8.2% in patients with ulcerative colitis and 75% in the presence of both indeterminate colitis and Crohn's disease [p < 0.0001].

Conclusions: Crohn's disease, indeterminate colitis, and stenosis with outlet obstruction are risk factors for failure of treatment after diagnosis of PI. Early aggressive therapy and surgery should be considered in these cases.
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http://dx.doi.org/10.1093/ecco-jcc/jjx140DOI Listing
February 2018

Transabdominal salvage surgery after pouch failure in a tertiary center: A case-matched study.

Dig Liver Dis 2018 May 26;50(5):446-451. Epub 2017 Nov 26.

Surgery of the Alimentary Tract - Digestive Disease Department, Sant'Orsola - Malpighi Hospital, Alma Mater Studiorum University of Bologna, Bologna, Italy.

Background: Salvage surgery after failure of ileal pouch-anal anastomosis (IPAA) could be offered to selected patients. However, the results vary widely in different centers.

Aims: To assess the outcomes of salvage surgery by comparison with a control group matched for confounding variables.

Methods: From a prospective database of 1286 IPAA, patients undergoing transabdominal salvage surgery were compared for perioperative and functional outcomes and quality of life (QOL) to a 1:3 control group of primary IPAA cases.

Results: Salvage surgery patients (30) had a higher rate of hand-sewn anastomoses (80 vs 20%, p <0.0001) and reoperations (10 vs 2.2%, p 0.02) than control group (90). A higher number of daytime and nighttime bowel movements (7.4 vs 4.1, p <0.0001, and 2.6 vs 1.8, p=0.002), a lower median CGQL score (0.7 vs 0.8, p=0.0001) and a higher rate of pouch fistulae (13.3 vs 1.1%, p=0.003) were reported after salvage surgery. Pouch failure rate after salvage surgery was 10.1%, 18.7% and 26.8% at 1, 5 and 10 years (vs 0%, 3.5% and 8.4% in control group, p=0.0085).

Conclusions: Although worse functional outcomes and decreased QOL have to be expected, salvage surgery after pouch failure is associated with acceptable outcomes when performed in a referral center.
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http://dx.doi.org/10.1016/j.dld.2017.11.011DOI Listing
May 2018

Real-time elastography for the detection of fibrotic and inflammatory tissue in patients with stricturing Crohn's disease.

J Ultrasound 2017 Dec 26;20(4):273-284. Epub 2017 Oct 26.

Department of Medical and Surgical Sciences (DIMEC), Alma Mater Studiorum-University of Bologna, Sant'Orsola-Malpighi Hospital, Via Massarenti 9, 40138 Bologna, Italy.

Purpose: The distinction between active inflammation and fibrosis of the bowel wall is essential for therapeutic decisions in stricturing Crohn's disease. We aimed to assess whether real-time elastography (RTE) with strain ratio measurement could be useful in differentiating fibrotic from inflamed bowel strictures and to evaluate the possible relationship between US techniques and the histology of the stenotic bowel wall.

Materials And Methods: Bowel ultrasonography (including RTE, color-Doppler and CEUS examination) was prospectively evaluated in 26 patients with symptomatic stricturing Crohn's disease, before surgery. RTE was adopted to evaluate bowel stiffness: five loops of 20 RTE frames were recorded for each stenotic segment and the mean strain ratio (MSR) was obtained. Histology scoring systems both for inflammation and fibrosis were established for surgical specimens.

Results: No significant correlation was found between MSR and fibrosis score ( = 0.877). Color-Doppler score was significantly related to gut wall and submucosal thicknesses ( = 0.006 and  = 0.032, respectively). There was no significant correlation between the number of vessels counted at histology and color-Doppler and CEUS examinations ( = 0.170 and  = 0.302, respectively).

Conclusion: MSR detection was not able to distinguish fibrotic from inflammatory tissue in our selected population. This result could be influenced by the presence of the superimposed inflammation. Larger cohort of patients, further analysis with shear wave elastography, and validated histopathology classification systems for fibrosis and inflammation are necessary to assess if intestinal fibrosis could be reliably detected on the basis of bowel elastic properties.
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http://dx.doi.org/10.1007/s40477-017-0265-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698189PMC
December 2017

Multidisciplinary management of patients with coexisting inflammatory bowel disease and spondyloarthritis: A Delphi consensus among Italian experts.

Dig Liver Dis 2017 Dec 23;49(12):1298-1305. Epub 2017 Jun 23.

Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Potenza, Italy.

Background: Treatment of patients with coexisting spondyloarthritis (SpA) and inflammatory bowel disease (IBD) often requires multidisciplinary collaboration between gastroenterologists and rheumatologists.

Aim: To describe the results of the first Delphi consensus to define shared therapeutic strategies for the best management of patients with coexisting SpA and IBD.

Methods: A scientific steering committee of 10 Italian experts in the field of SpA and IBD developed 27 statements on 5 possible clinical scenarios and selected 40 specialists from across Italy, both gastroenterologists and rheumatologists, to vote them using a Delphi method. Each participant expressed a level of agreement on each statement using a 5-point scale (1="absolutely disagree"; 5="absolutely agree"). Total cumulative agreement was defined as the sum of the percentage of responses to items 4 ("agree") and 5 ("absolutely agree"). Total cumulative agreement ≥70% defined consensus for each statement.

Results: After the first round, positive consensus was reached for 22 statements. Statements without consensus were discussed in a plenary session before the second vote. Positive consensus was then reached in all statements, with final total cumulative agreement ranging from 80% to 100%.

Conclusion: This is the first Delphi consensus defining specific treatment algorithms for patients with coexisting SpA and IBD.
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http://dx.doi.org/10.1016/j.dld.2017.06.004DOI Listing
December 2017

Case-control Study on Dactylitis, Enthesitis, and Anterior Uveitis in Spondyloarthritis Associated with Inflammatory Bowel Diseases: Role of Coexistent Psoriasis.

J Rheumatol 2017 Sep 15;44(9):1341-1346. Epub 2017 Apr 15.

From the Rheumatology Division, Hospital of Prato; Department of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.

Objective: To evaluate the frequency of dactylitis, enthesitis, and anterior uveitis (AU) in spondyloarthritis (SpA) associated with inflammatory bowel disease (IBD-SpA) compared with other SpA, and to assess the role of associated psoriasis in the occurrence of dactylitis and enthesitis.

Methods: In a 12-month case-control study, the frequency of dactylitis and enthesitis in 29 patients with ulcerative colitis (UC) and 59 with Crohn disease (CD) who satisfied the Spondyloarthritis international Society criteria for axial or peripheral SpA was compared with 176 controls, including 97 (55.1%) with psoriatic arthritis (PsA), 47 (26.7%) with ankylosing spondylitis (AS), and 32 (18.2%) with nonradiographic axial SpA (nr-axSpA). The occurrence of these features in IBD-SpA with and without psoriasis was also evaluated.

Results: Axial, peripheral, or mixed involvement was observed in 46 (52%), 29 (33%), and 13 (15%) patients, respectively; and 14/88 (16%) had psoriasis. Dactylitis was recorded in 4/88 patients (4.5%) with IBD-SpA and in 30 controls (17.4%; p = 0.008), enthesitis in 16 cases (18.1%) and in 78/176 controls (44.3%; p < 0.001), and AU in 3 patients (3.4%) with IBD-SpA and in 26 controls (14.7%; p = 0.01). No significant differences were found between patients with UC-SpA and those with CD-SpA. Dactylitis and enthesitis were significantly more common in patients with IBD-SpA who also had psoriasis compared to those without skin disease (p = 0.009 and 0.003, respectively).

Conclusion: Dactylitis, enthesitis, and AU are significantly less frequent in IBD-SpA compared with other types of SpA. Given the frequent association of psoriasis and IBD, overlooking coexistent skin disease may lead to overestimating the frequency of these features.
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http://dx.doi.org/10.3899/jrheum.161518DOI Listing
September 2017

Use of corticosteroids and immunosuppressive drugs in inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease.

Dig Liver Dis 2017 Jun 25;49(6):604-617. Epub 2017 Jan 25.

Gastroenterology and Digestive Endoscopy, ASST Fatebenefratelli Sacco, University of Milan, Milan, Italy.

The two main forms of intestinal bowel disease, namely ulcerative colitis and Crohn's disease, are not curable but can be controlled by various medical therapies. The Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) has prepared clinical practice guidelines to help physicians prescribe corticosteroids and immunosuppressive drugs for these patients. The guidelines consider therapies that induce remission in patients with active disease as well as treatment regimens that maintain remission. These guidelines complement already existing guidelines from IG-IBD on the use of biological drugs in patients with inflammatory bowel diseases.
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http://dx.doi.org/10.1016/j.dld.2017.01.161DOI Listing
June 2017

Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).

Dig Liver Dis 2017 04 17;49(4):338-358. Epub 2017 Jan 17.

San Giuseppe Hospital, Gastroenterology, Milan, Italy.

Inflammatory bowel diseases are chronic conditions of unknown etiology, showing a growing incidence and prevalence in several countries, including Italy. Although the etiology of Crohn's disease and ulcerative colitis is unknown, due to the current knowledge regarding their pathogenesis, effective treatment strategies have been developed. Several guidelines are available regarding the efficacy and safety of available drug treatments for inflammatory bowel diseases. Nevertheless, national guidelines provide additional information adapted to local feasibility, costs and legal issues related to the use of the same drugs. These observations prompted the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) to establish Italian guidelines on the safety of currently available treatments for Crohn's disease and ulcerative colitis. These guidelines discuss the use of aminosalicylates, systemic and low bioavailability corticosteroids, antibiotics (metronidazole, ciprofloxacin, rifaximin), thiopurines, methotrexate, cyclosporine A, TNFα antagonists, vedolizumab, and combination therapies. These guidelines are based on current knowledge derived from evidence-based medicine coupled with clinical experience of a national working group.
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http://dx.doi.org/10.1016/j.dld.2017.01.141DOI Listing
April 2017